Transcripts For CSPAN2 Prescription Drugs Law Enforcement And The Opioid Epidemic 20171227

[gavel banging] welcome, everybody, and thank you for your attendance, particularly those who have to testify and answer questions for us because i know you put in a lot of extra work to be ready for it. This hearing is on the oversight of a bill that has a long name called insuring Patient Access and effective Drug Enforcement act. Now somebody is going to have us pronunciation for the acronym. Im not going to. Im going to refer to as the law and the bill. Some would like to see this law repealed. Others insist that it should remain in place. I havent made my mind up on that issue. So i am interestedn hearing both sides of the argumt. This discussion is particularly important giving the continuing Opioid Epidemic that has ravaged this country through the past several years. I do have concerns with how we got to where we are today and the discussions that were having today. When Congress Took this bill up in 2015, and 2016, there was little, to no fanfare about the proposal. The basic goal of the bill seemed very modest, provide a definition for the term, imminent danger. Distributors and other providers would have more clear guidance for what was required of them before dea could issue an immediate suspension order called iso in this industry an iso can be a death sentence. From their standpoint the clarification seemed not only fair but a necessary step in helping figure out how to comply with the law. There was another practical concern, that of ordinary patients with legitimate needs having access or losing access to essential prescriptions if legitimate distributors were shut down. Dea understandably had some concerns about curbing their Enforcement Powers but unlimited, undefined Enforcement Authority needed some refinement. Dea also had litigation risk with such undefined authority. So dea too had an interest in working towards amending the language to reduce their own risk. My understanding was that dea provided Technical Assistance to both house and senate staff for other members who were responsible for drafting the bill. In fact, dea admitted as much in testimony before the house representatives october of this year. When the bill came to the senate it was referred to this committee. I took up the bill based in part on assurances from dea and the department of justice that they agreed to the language in the final bill. We discharged the bill from committee. We did that by unanimous vote. The bill then passed the senate by unanimous consent. It also passed the house by unanimous consent. President obama signed the bill into law april 2016. Dea testified that they had advised president obama to do just that. So let me be clear. If dea or the department of justice didnt want this bill, i wouldnt have taken it up, period. Then the Washington Post and 60 minutes ran pieces criticizing the new law. Both stories highlighted former dea employees and quoted a law review article from the acting chief Administrative Law judge for dea. The reports in the media suggest that congress was in the back pocket of the opioid industry, and that this bill was a giveaway to the Prescription Drug industry. So as i have described it should be fair to everybody to see, fairly clear to everybody to see that nothing could be further from the truth. I have worked hard my entire career trying to combat illegal drug trafficking. My friend here from california and i have worked together on a group called the drug caucus, to do just that, besides the work we do on this committee. We did it to provide more effective ways for Law Enforcement it do their job in the Drug Enforcement area. Im especially frustrated by the dea itself, which Gave Congress the go ahead to enact this legislation. We wouldnt be here today if the dea told us they objected. The news reports also suggest that the law effectively stripped dea of its enforcement power. The data appears to show otherwise. Prior, in other words, the data shows this, the, prior to passage of the bill, between the years 2011 and 2015, the amount of immediate suspension orders dramatically decreased since the law was passed, the amount of the immediate suspension orders has increased. Moreover, the number of opiates distributed overall decreased between 2016 and 2017, which all comes after passage of the bill. Dea has said that the law, quote, did not stop dea from doing its job in in the diversin space. Even though this bill was vetted by congress once, we all have to be open, at least im open to reexamining the criticisms of the law and hence were here. Im looking forward to the hearing what those are. In other words, what the criticisms of the law are. But we shouldnt be repealing laws just because the loudest person in the room, and solely based on one persons sayso. The dea agent who was the center piece of the news article is a consultant for trial lawyers for suing the industry. So his objectivity could be questioned. The sensational news stories failed to question this conflict of interest. I look forward to hearing the testimony from the witnesses and finding new ways to strengthen our Law Enforcement efforts without preventing legitimate access to medications that real patients with real legal prescriptions need. Opioids continue to be a huge problem if this country. It is vital that our federal laws keep up with the best way to combat illegal opioid use. Before we start, i have a prepared statement from congress manage tom marino, author of this legislation, original cosponsor of the bill and he introduced the house version. I have a statement from congressman tom marine yo that im going to enter into the record without objection. Now senator feinstein. Thanks very much, mr. Chairman. Im very disappointed that neither the dea nor the Justice Department would allow dea chief Administrative Law judge mulroney who wrote a law review article that was critical of this law to testify. In that regard im going to put in the record a letter dated december 12th from an assistant attorney general who didnt bother to sign it himself and i cant make out the handwriting of the person who did but essentially saying we have other people and they will not make him available. First time in 25 years ive had this kind of thing where somebody we wanted to be a witness was not permitted to come before the committee. Today we are confronted with three indisputable facts. One,ere in the mid of an Opioid Epidemic, the likes of which this country haser seen. Two, we have a collective responsibility to better address it. And three, clearly, Law Enforcement cant keep up with it. Recent news reports claim that this bill, which was enacted in 2016 is partially to blame for this struggle. The law does four things and let me point them out. It outlines the conditions that must be met by drug manufacturers and distributors in order to obtain a dea registration. Two, it defines whats, quote, imminent danger to the Public Health or safety. End quote. In doing so, it lays out the circumstances under which did. Ea may issue an order to show cause. An immediate suspension order or revoke a registration. These circumstances were not previously defined, which left registrants unsure when dea might ache action against them. This point was underscored in the 2015 gao report which made three recommendations to dea how to improve communication with registrants in order to insure. Third the law allows registrants to submit a corrective action plan prior to dea suspending or revoking the registration. It also stipulates when an imminent danger exists, dea may immediately suspend a registration. Even if the registrant submit as correction action plan. Finally, the law required by the department of health and Human Services to report to congress on how Law Enforcement can better collaborate with the pharmaceutical industry to increase Patient Access and prevent drug diversion. The department is eight months late in submitting this report, and it has failed to respond to the inquiry the chairman and i made about it. Data provided by dea does not seem to support the argument that this law has hipped dered its enforcement efforts. To the contrary it shows that dea Enforcement Actions, while now starting to increase, pebegan declining well before law is enacted. Between 2011 and 2016 immediate suspension orders filed against pharmacies went from 21 to four and those filed against practitioners went from 43 to five. The last time an immediate suspension order was filed against a manufacturer or distributor, and this order immediately stops the distribution of pills was guess what . In 2012. Between 2010 and 2016 Civil Penalties leveled against distributors dropped from 3. 1 million to a mere 115,000. Sounds to me like something isnt working. So during the same years that we saw opioid Overdose Deaths increase by 57 , deas Enforcement Actions in many categories substantially declined. What i want to know is why . Something isnt working. It needs to be fixed. If it is not the law, and i have asked dea and the Justice Department for their assistant assistant assistance in looking at the law then we need to figure out where the problems lie. Ive been struck by the examples of negligent distributors raised in recent hearings and round tables. Let me give you an example. In a twoyear period nearly nine million opioids were delivered to a single pharmacy in West Virginia. Nine million pills to a single pharmacy in a small state West Virginia. Further, between 2007 and 2012, distributors delivered 780 million oxycodone and hydrocodone pills to pharmacies throughout that state. The result . A reported 17 billiondollar profit for distribution companies. And heres the price. 1728 fatal overdoses over six years. 1728 fatal overdoses versus a 17 billiondollar profit for distributors. Consequently many distributors faced and settled lawsuits with the state. Yet almost all of them maintain that prescribers, pharmacies, and Law Enforcement are better situated than they are to prevent diversion. It is hard to imagine a circumstance under which a request for nine million pills to a single pharmacy, or 780 million pills to a single state would not set off warning bells to those distributing them. In my judgment there was no excuse for the continued shipment of these drugs. The regulations promulgated by the controlled substances act require manufacturers and distributors to conduct Due Diligence of their customers. To detect and disclose suspicious orders to dea, and to keep complete and accurate records relating to the manufacture or distribution of controlled substances. It may well be that dea nodes to issue more guidance as to what constitutes a suspicious order thesexamples illusate the fact that some distributors appearedo be more concerned with their bottom line than fulfilling their responsibilities under this law. Bottom line, we cant turn a blind eye to this kind of reckless disregard. And Law Enforcement must actively pursue these kinds of cases. With that i look forward to hearing from our witnesses about how and whether this law should be modified. We can not continue, ladies and gentlemen, to lose more than 33,000 americans each year to an epidemic thats entirely preventable. Thank you, mr. Chairman. I want to associate myself with the disappointment that senator feinstein expressed that the witness we asked to come was denied coming by the administration. And today we sent a letter to ask reasons why because we didnt get proper justification. Of course now writing that letter doesnt do any good except to give justifiable reason if they have one, and i doubt if they do. If it is okay with my colleagues, i want to call on senator hatch before i introduce our witness because of his leadership on this issue. So would you proceed senator hatch. Thank you, mr. Chairman, for holing this hearing, allowing me to make a statement. Too often in this town narrative gets ahead of facts. A newspaper prints explosive heading it is off to the races. Doesnt matter what the actual facts are. Bandwagon starts rolling and Everyone Wants on or off as the case may be. Mr. Chairman i was dispriced how everyone was running from the bill the moment negative news reports came out from senator mccaskill, to senator manchin, to attorney general sessions seems like everyone tried to wash their hands of it, but no one ever told me they were dubious about this bill when it was going through. No one enter ad statement of opposition into the record or offered an amendment to change the bill. To the contrary the bill passed this committee by voice vote and passed the full senate by unanimous consent. So these last two months have been deeply frustrating to me, mr. Chairman. I wish some of my colleagues would stop trying to rewrite history or pretend this was some sort of shell game. Thats why im glad were holding this hearing today. I want to talk about the facts, the facts of this law, the facts of my involvement and this committees involvement and the facts of the laws impact. Lets start with the i impetus r this law. This law came about not because i or anyone else got some giant check b because of very real ncerns that the way dea was operating was threatening Patient Access. Representative marino said he became involved after meeting with a Community Pharmacist in his district who was, quote, having so much trouble obtaining prescription opioids, that he had to turn away legitimate patients, unquote. I heard similar concerns from constituents. One of whom who will be testifying today. It wasnt just utah and pennsylvania. Across the nation pharmacies were facing supply chain problems. January 2014 survey by the national Community Pharmacists Association Found that 75 of respondents had experienced three or more problems would stop ship. S in the previous 18 months. A majority had to turn patients away as a result. News reports from indiana to florida detailed stories of legitimate patients who were having significant difficulty obtaining needed medication. No doubt these supply chain problems had multiple causes but deas activities were a contributing factor. According to a 2015 gao report the lack of clear guidance from dea to distributors what cons stouts a suspicious order and what can trigger an enforcement action was leading many distributors it place quotas on drug shipments to pharmacies, a practice the report found can quote, negatively impact patients access unquote. The report detailed how fear of Enforcement Actions coupled with lack of Agency Guidance was leading distributors to decline to fill orders even in cases where a distributor had no evidence that a pharmacy or doctor was engaging in diversion. It wasnt just a lack of guidance. I have had a number of individuals tell me that deas attitude towards registrants during this period wasdown rite antagonistic. I have a letter here from a vcu professor that describes some really troubling conduct by diversion control agents and that explains how difficult he found it to work with the agency in good faith. It wasnt just the private sector having difficulty with dealing with dea either. In 2015 separate report about drug shortages, they described great difficulty getting information from deas office of diversion control. According to the report, completion of gaos work was quote, delayed significantly because of deas refusal to comply with gaos request for information for over a year, unquote. Only after the intervention of quote, senior doj management officials, unquo was gao able to obtain the data it was seeking. Insuring Patient Access and effective Drug Enforcement act was an effort to respond to these problems, to provide clearer guidance for supply chain members and to encourage greater cooperation between dea and the requested community. Thats why it defined agencys immediate suspension Order Authority and thats why it provided for corrective action plans. This wasnt some effort to help Drug Companies to kill people. Give me a break. This was an effort to insure that deos praise worthys efforts to stem abuse dont end up hurting legitimate patients. Id like to just say a word about how this law came together. Want to be clear right at the outset this was not a pharma bill. Dont tell me i did this bill because pharma donated however much money to me. Prior to introductions senator whitehouse and i negotiated with dea distributors and Patient Advocacy groups. We may have talked to a Pharma Company at one point or another but they were not key players. You know what . The bill senator whitehouse and i introduced doj was okay with it. They said so in writing to this committee. Of course legislation is a process and aft intduction i thought it was necessary to make changes in order to move the bill forward. I would have preferred not to but we all know that legislation requires compromise. So i had to accommodate some requests from industry sheikh stakeholders at requests of other members of this committee. I negotiated changes with dea and doj in fact the department of justice gave me the substantial likelihood language that critics seem so fixated on. Once dea and i came to a point where we agreed on a path forward i asked the chairman to put the pull on a markup. I kept my end of the bargain. I told other members that what dea had asked me to tell them and made the floor and record statements i promised dea i would make. I did all of this in good faith. I later came to find out notwithstanding our agreement, dea and doj were telling other offices they still had some concerns with the bill. For reasons i dont understand, they never shared these concerns directly with me. But evidently the concerns were not that significant as dea did not try to stop the bill. As all of us on this committee know, any bill can be stopped by agency opposition. All it takes is one hold. That is how we got here. The bill addressed a very real problemnd it did so in a carefullycrafted, carefullynegotiated way. If dea has concerns with the bill im happy to hear them but i would also ask dea to explain why those concerns did not cause it to stop the bill 18 months ago before it became law. With that i thank you for allowing me to make comments, mr. Chairman. Mr. Chairman . Senator whitehouse. I will only speak briefly. I accept and adopt the remarks of senator hatch. The only thing i would add to them is that in addition to everything that he has said we even then built a backstop into this bill to make sure that there was no harm from it and we gave responsibility for that backstop to a separate agency than dea, hhs was given the legal obligation to do a report on what the result of this bill was so that we would know how to respond. They are now late and in violation of law. They have not provided that report, and i think it would be very helpful if we were having this hearing with the legallyrequired hhs report that we demanded. I think it is fine to go ahead without it, given that they have delayed but this would be more productive hearing if hhs had done its job as we required. We would have better information to look at this, and in terms of the good faith of this proceeding, very clearly building in that review backstop was a strong signal that we really wanted to get this right. Okay. Im now going to introduce our first witness, miss ashley. Then i will swear her. Well listen to her testimony. Then well have questions her. She represents the u. S. Drug enforcement administration. Miss ashley is currently the acting assistant administrator the Diversion Control Division of that agency. Has worked whin that agency for now over 30 years. As acting assistant minute tore for dea, miss ashley oversees investigations an influences regulations and advises National Security staff, government agencies, media and private organizations on matters related to the diverse of legallyproduced controlled substances. Would you please stand and let me issue an oath. Do you affirm that the testimony youre about to give before the committee will be the truth, the whole truth and nothing but the truth, so help you god . [inaudible] thank you for your ascent. You may proceed with your testimony. As usual if you have much longer testimony it will be placed the in the record. I never rap the gavel after five minutes, but try to wrap up as soon as you can after that time happens. The red button. Chairman grassley, Ranking Member feinstein and distinguished members of the committee. Thank you for the opportunity to discuss the insurance Patient Access and effective Drug Enforcement act. This legislation altered the procedures that government, the manner in which dea seeks to revoke registration against those who continued, whose continued authority no longer, is no longer consistent with the Public Interest. Sadly over the past 17 years our nation has been devastated by the opioid abuse with more than 300,000 open i cant thinkrelated deaths. The epidemic created a generation of abusers, currently estimated at 12 million. While prescriptions for schedule 2 opioids have begun to decline, making schedule 2 opioids less accessible, mexican drug cartels filled the void by producing cheap heroin, counter fit pills often mixed with fentanyl. The results are tragic. With 64,000 estimated Overdose Deaths in 2016. I want to assure this committee that dea uses all stools, administrative, civil, criminal, to insure the 1. 7 million registrants comply with the law. Since 2011 dea revoked nearly 1000 registrations each year. Through orders to show cause, immediate suspension orders, voluntary surrenders. Isos are used judiciously and historically used against those directly responsible for causing harm in the community. Doctors writing illegitimate prescriptions and pharmacies that filled those prescriptions. As someone with 30 Years Experience as a diversion investigator and now as head of the dea Diversion Control Division i have used all these tools to counter the drugs, the diversion of controlled Prescription Drugs. Isos are not our only tool and should not be the sole metric by which dea measures success or failure. We have also aggressively pursued civil actions designed to assure compliance with the csa. Over the last decade dea levered nearly 390 million worth of fines against opioid distributors. Entered into memorandums of agreement with each distributor that established additional compliance measures to assure they report suspicious orders. The same distributors are now the subject of investigation by a coalition of 41 states attorneys general. The dea is sharing information in support of those investigations. Dea is also, has also prioritized this criminal investigators by embedding them alongside diversion investigators in groups called tactical diversion squads. These groups are solely dedicated to investigating, disrupting, and dismantling individual organizations involved in diversion schemes. Since 2011 dea has more than doubled the number of tactical diversion squads to a present total of 77. Last week we announced results of operation faux pharmacy. This ongoing effort targeted 26 pharmacies in california, nevada, and hawaii. To date this ongoing evident resulted in 23 arrests, 4. 3 million in cash, and perhaps most importantly, for purposes of this hearing 10 voluntary surrenders of pharmacy registrations. We are also scheduled to increase the number of tactical diversion squad to 100 by 2019. The Diversion Control Division also works closely with registrant community to educate them of their regulatory requirements under the controlledded substances act. We currently complete ad, recently completed a nationwide Training Initiative to raise awareness on the importance of the, that pharmacists play in filling valid prescriptions. We offered this training free of charge in all a states, the District Of Columbia and puerto rico and trained 13,300 pharmacies and pharmacy technicians. Im happy to announce in 2018 we will begin a Similar Initiative to train doctors on recordkeeping and other regulatory requirements. Many of our colleagues have asked how is this legislation impacted dea . While it has not prevented us from issuing isos, we have issued nine since the bills enactment, the new standard does make it more difficult to issue an iso to noncoy ply ant manufacturers and distributors this law has changed the manner in which dea pursues orders to show cause against registrant. The law gives the registrant opportunity to submit corrective action plan. A very small percentage of registrants who have been subject of an order to show cause proceeding have submit ad corrective action plan and none have been approved. Regardless of the Legal Framework which we operate dea will continue to work tirelessly to combat this devastating Opioid Epidemic. If congress decides to revisit this issue, let me assure you that our agency will work with the department, we will be there to assist as we have done many times before. Thank you for your commitment to combating this epidemic and i look forward to your questions. Thank you, miss ashley. Well have five round of questions. Rounds. Leading into my first question i will not a repeat a lot of stuff i made in my Opening Statement but kind of adds up to the law when it was passed, it was not controversial. So my first question is, my understanding is that dea is in favor of quote, unquote changes to the law but would not give congress an answer whether dea wants to repeal it. Does your agency have an answer to that basic question here today of whether or not you want it repealed . Seems to me a Pretty Simple question. Do you favor repealing the law or do you favor amending it in some way. Im sorry, senator, in collaboration with the department of justice, dea and the department of justice are in, we are in agreement with a change. And that change what that change will look like ultimately is, was going to require further discussion but, what we believe now, were leaning more toward just amending it. Making changes . Yes, just making changes to the existing. Do you agree that there was a need to change the law in the first place . Isnt that why dea agreed to provide tech al assistance to the members ofongress who drafted the bill, talking about the bill that is now law . Sir, im in a difficult position here today because i wasnt present for any of those conversations and to that measure, neither were, it was a different administration. So its really difficult for me to try and put, piece together who the conversations were with and how they went about, but i can tell you here today, i can give you a feel for how its made it harder. That is since its enenactment. When i came on board. You see we have a chart up here. Both senator feinstein and senator hatch made reference to some of these figures as i did. This data was provided by dea showing the number of immediate suspension orders or isos as we call them between the years 11 and 17. The data shows isos went down dramatically between each. In 2011 dea issued 65 isos. By 2015, the number was down to five. This all happened prior to the enactment of this legislation. My question, couple questions. Doesnt this data pretty clearly show that particular bill had no effect on deas enforcement ability and would you say, in answering that question, that the data directly contradicts claim, that quote, congress effectively stripped the dea of its most potent weapon by enacting the legislation, end of quote, that the law made it, quote, virtually impossible for dea to freeze suspicious narcotics shipments, end of quote . Senator, im careful not to conflate the two because when dea, when we conduct investigations, we go where the evidence takes us. So we do what needs to be done is the bottom line. And in those, so if order to show cause is not warranted at time, that is not the direction we go in. So i dont want to conflate the two number of isos went down. It could have increased increasn another area. It could have increased, we have several tools in our tool box. When dea engages with a registrant we have the responsibility to detect and prevent diversion and we also have the responsibility to insure medicine gets where it is supposed to be. That access is available. So when we engage we may have made the decision to administer a letter of admonition or to do a memorandum of agreement, or to do an informal hearing. So again im not necessarily wanting to conflate the two because isos or im sorry order to show causes may have gone down but may have gone up in another area. Without agreeing or disagreeing with your decision not to conflate, it seems to me when someone else from dea testified in house that this bill, quote, did not stop dea from doing its job in the diversion space, end of quote, isnt that, somebody else in the Department Says that, isnt that right . He also testified that the same hearing, at that same hearing that this data did not show that the law fueled the Opioid Epidemic . Isnt that right . Because that is coming from somebody in your department. In our department, and i agree wholeheartedly it does not stop us from doing our job. We find a way because, you know, again as, this committee, speakers have already stated, this is a prescription opioid, this is open i cant think epidemic. We use every tool within our boundaries that we are authorized to use to combat this, to combat this problem. How, this will be my last question, i have to go to senator feinstein, how exactly has the dea had to change its iso procedures after the bill was enacted . Senators the way i can do that best is to provide an example. Prior to the legislation we were able to, well, our mindset was to pursue these types of investigations, from a preventative measure. I will give you the example, even the one brought up is a little earlier, distributor shipping millions of dose ann units of bills to a pharmacy in West Virginia. That pharmacy is responsible by law and regulation to report suspicious orders to the dea. Theyre response to do Due Diligence whether or not the controlled substances they are handling, they are accountable for, and to make sure basically try and prevent any diversion. So prior to the law if there were distributors who would do these types of things, send those type of, millions of those units to a pharmacy, not reports suspicious orders, we have found in particular cases internal documentation that would state, basically giving guidelines how to circumvent dea regulions. So prioro the law that was enough grod for an order to show cause. No now that the law has passed it state has it has to be a substantial likelihood of an issue, it has to be immediate, it has to show abuse. So, if i could give you this example, real quickly, im looking at my time here, give you example of a distributor, of a patient who has died. So we have death now, going getting a prescription from a pharmacy, the pharmacy and the patient fills the prescription at pharmacy, sells that medication and someone dies. With the law in place now, i need to make connection and nexus between that distributor and a death, versus prior to the legislation i can do it on the prevention, on the prevention level. This is before the pill, i can start immediate suspension order on the distributor before it leaks out and gets down and connects to a death. So the legislation now states that there must be death, serious bodily harm or abuse. Prior to that it was diversion. Senator feinstein. Then i will step out for a minute. After time is up senator hatch if i dont get back. But i think i will be back. Thanks, mr. Chairman. I am looking at the dea immediate suspension orders from 08 to 2017. In 2011 there were 65. In 2017 there were six. In 2015 where i pointed out 33,000 people died of overdoses, there were five. I look at the aggregate production quotas and there are four criteria. These factors do not include trends of abuse or overdose death rates for specific classes of drugs. They should. I mean how do we keep functioning and let this happen . Senator, if i could answer the question in two parts. First, addressing the immediate suspension orders. I will go back to investigators going where the evidence takes us. If, if immediate suspension order is warranted, that is where we pursue the investigation. In speaking to the quotas, the difference is, im sorry senator, your question in the beginning regarding to the quotas . Well the quotas dont include trends of abuse or overdose death rates or specific classes of drugs. Why knots . I recall, so that is something we have to be very careful about. As i mentioned, we want to prevent and detect diversion. We have to sure adequate supply. As far as making the determination of the, of the trends we are bound by statute when we make, when we determine what the aggregate quota is going to be. Were bound by statute so some things have to be there. I would need to take back to our quota section and to our office and have a more lengthier discussion how that type of, how that type of thing can be added to, what the statute already exists. Let me say something. I just take this with the greatest sense of alarm that we have all these deaths going on an nothing changes . If i can say i think your answer is really not a good answer. I mean every alarm signal is out. People are dying by the tens of thousands. Yes, senator. And yet the shipments go on, and dea, in my view is not doing its job. Senator, if i could respond to that. Again we are bound by statute when it comes to quota but there is something that we can do on that, on that subject. If the dea can determine that a specific Manufacturers Product has been tied to you know, the proliferation of drugs in one community how about the West Virginia case of small pharmacies . No exactly. In that type of circumstance what can happen, now this is after one specific drug is identified, one specific manufacturers drug is identified. We can decrease their quota. I hear you, senator, and i understand and i would very much like to take that back and continue to work with your committee. So in other words presently small pharmacy can receive millions of pills and nothing happens . That is not the way it should work, senator. What should it is working that way. You just said that is the way it work. Senator what, a distributor is responsible to do to exercise Due Diligence. They are responsible to have great care and accountability over the shipments that they send out. That is where dea comes in with the oversight and regulatory controls. Well, when 33,000 people die in a year from overdoses, maybe a few distributors should be shut down. That is exactly the way i feel. I hear you, senator. I think this whole view of business as usual is just not working. So, the administration really becomes libel for not making the changes that are necessary to prevent these Overdose Deaths from happening. And, i have never said this before. I have bee on this committee for a long time. But i have never seen a more lax operation. I just, i cant help but say that. When people die, because of it, get really angry. Thank you. You bet. Senator hatch. Before i begin i would like to ask if we can do second round of questions with this witness after everyone else had their opportunity to go . I think we will have time for that. Okay. Make a judgment after we see how many members come, but the way it is right now i think we can. Okay. As you can imagine i have a number of questions for her. I would like to start, miss ashley, by talking about immediate secession orders, or isos. There is a lot of allegations that the immediate suspension act gutted deas ability to give secession orders and plummeted. Lets look at actual data. I have a chart of isos issued by dea over the last 10 years. This data comes from dea. I have give ive enyou a copy to refer to. You see isos start off in low double digits in 2008, peak in 2011. Decline until around 2014. Then stablize thereafter. The vertical dotted line represents when the insured, insuring Patient Access act was passed. This did actually, when you look at this chart, which shows the decline in isos began four years before the insuring Patient Access act, is there any way the act could have decaused a decline in isos . Senator, this is a tool for immediate suspension orders that the dea historically used sparingly. We move forward where the evidence takes us. They have been used sparing but used for the most part predominantly for physicians and also for pharmacies. Its a difficult challenge to connect a distributor and i was asking for a yes or no answer . Has it changed . Has it impacted our ability to do, to issue isos . No, sir, it has not. In fact you will note dea issued more isos in 2017, the year before the act passed, then it did in 2015, the year before it passed. I also direct your attention to the short orange bars on the chart. These represent isos against distributors and manufacturers. The blue bars are total isos, and the orange bars are isos against distributors and manufacturers. Isos against distributors and manufacturers have been particular focus of news reports criticizing t bill. Now these reports have described these is as deas most effective tool against large Drug Companies. Now this actually, looking at the chart, when the insuring Patient Access act passed in april 2016, how many years had it been since dea had issued an iso against a distributor or manufacturer . The last one was 2012, sir. Im sorry, i didnt hear you. The last one was 2012, sir. Okay. It had been just under 3 1 2 years as i see it. So not only could this law not possibly have caused a decline in isos, but at the same time the law passed it had been over three years since dea had issued an iso defense the distributor or manufacturer. Simply put the notion that isos against distributors manufacturers were a frequently used tool before the insuring Patient Access act passed and that the act caused deas use of the tool to dry up, is simply not correct, would you agree . Yes. I do agree, sir but okay that is all, in fact over the last decade the most isos against distributors or mervers that dea ever issued in a single year was three. Now there is also been criticism of the acts requirement that dea notify companies of the ability to submit a corrective action when issuing a showcause order. Judge mulrooney in fact used strangely intel rat language in is article, it was akin to allowing bank robbers to rob and return inkstained money and be agree not to rob anymore banks. I have to say that is a bit much. The it was to insures greater cooperation between dea and supply chain members t was to avoid a situation some doctors and phaacts wereacing in which dea aljs would not allow them to present any evidence of corrective action unless they first accepted responsibility for all of the conduct that dea alleged, even if the doctor or pharmacy had not committed all of the alleged conduct. In just, just to clarify the corrective action plan provision applies only to show cause orders. There is no requirement in the act that dea provide an opportunity to submit a corrective action plan before issuing an iso. Suggestions to the contrary are incorrect. I do have another chart. I guess i will have to wait until i senator leahy. Thank you, mr. Chairman. This is troubling. Obviously dea or someone totally dropped the ball in West Virginia. Deaths occurred. The people selling the drugs made a lot of money. They knew they were selling far, far more than there could conceivably be a need for medicinal purposes and, while the legislation were talking about passed the house and Senate Nobody at dea opposed it when asked. So the whole thing is so murky. It seems the people selling, and the pharmaceuticals are about doing ones who are coming out well in all of this. Now there has been a lot of discussion regarding the startling drop in deas use of immediate suspension orders but isos dont capture all the story. During that same period when they went from 65 in 2011 to to is 10 in 2010, i understand to 110, i understand there were voluntary, as many as 1000 a year, is that correct . Yes, sir. Can not a voluntary surrender be a quiet resolution to any serious criminal investigation . Its a resolution and its a great tool for us, sir. But it also having to avoid paying any criminal, criminal charges, is that correct . So with the order to show cause in the iso there would not be criminal charges, sir. But it is administrative action that would immediately stop the registrants ability to handle controlled substances. So its a great tool for us. But they dont have any penalty or public admonishment. Somebody else can step in and starting doing exactly the same thing, that correct . Yes, sir, that is correct. I, as former prosecutor, i did think sometimes of criminal actions as being a deterrent. If you have a 1000 of these noncriminal actions a year, is that really working much as a deterrent in your estimation. Its a deterrent stir, one thing we keep in mind, we have a 1. 7 million dea registrants and overwhelmingly majority are doing the things the right way. There is that very small percentage, may be violators, bad actors of the substances controlled act. Theyre a tightknit community as most professionals and when theyre in the same business activity, i believe in my experience it does cate deterrent effect. Would you look at that letter and respond to us . Yes. You said that the d. E. A. Said they working to provide specific guidance regarding the identification and reporting of suspicious orders, as of a year ago, when will we see that guidance. Yes, and i anticipate it will be spring, and actually, in the spring, we also have a meeting with a stake hold registrant. Are you affected at all by President Trump saying youre going to have a regulation, youre going to get rid of two former regulations . Certainly, we have to be in compliance with, you know, with the acts that are place. Certainly, we have to be in compliance with that, but that doesnt prevent us from continuing to draft regulations. Thank you, mr. Chairman, i think under those circumstances, if i was going to be involved with criminal activity, i would love that order one step forward two steps back. I thank you for your commitment to get that letter and ill look forward to it. Absolutely, sir. Thank you mr. Chairman. How long have you been with the d. E. A. Over 30 years, sir. And youre the acting assistant commissioner. Yes, sir. Does that mean youre the number two. No, id say im three down, but theyre top five . Top nine. Host top five . Top nine, sir. What was your position under president obama . For a period of time i was the Deputy Assistant administrator and prior to that i was the Program Manager in the chicago field division. So you were a senior official . Yes, sir. What was your opinion at the time of the insuring drug access enforcement acts. So if i can clarify, sir, i reported under basically under the end of president Obamas Administration in october of 2015. So, by the time i recorded all of those conversations had already passed. I appreciate that clarification, you were aware of this act . Yes, sir. When it was a bill. Yes, sir. Were you for it or against it. I was concerned about it, sir. To whom did you express those concerns . It internally to my staff. Okay. Did you express you crcerns to anybody senior . At the time would have been by immediate boss who is no longer there. Did you tell your immediate boss about it . Yes, if i could explain, we all reported. And it was a sweeping new management and he was just familiar with the bill so he was not about of the conversations. Among those top ten people when this act was a bill. Among the top ten people at d. E. D. E. A. , who opposed this bill . Sir, i could name names, but none of those individuals are currently at d. E. A. Okay, name names. The prior Deputy Assistant administrator, mr. Joseph he opposed it or for it. He opposed it. Who else . It would have been his management staff. Id like some names, if you could. Immediately under him, he had a deputy and i would be not precise on their time frames or when they were in the chair. Alex santos at the time. Okay, who else . The administrator at the time would have been michelle lynnheart. Who else opposed it . Has a i can think of, sir. If youhink of others, could you write me . Sure. Who among the top ten managers d. E. A. At the time, who enforced it . I wasnt present so difficult for me to say who did support it. Who did you hear . I didnt have had a conversation with anyone that told me they supported the bill. Okay. So nobody did . And you were im saying i didnt have a conversation, its not that no one did. Im not aware of it is what im saying. Well, somebody had to. I believe youre correct, sir. All im saying, i didnt know that, i didnt have conversation with those who had. Well, who would know that . Im trying to think of someone who is currently at d. E. D. E. A. , that would have been part of those conversations. Currently our acting administrator was not part of that conversation and myself, and my direct i directly report to the principal, deputy administrator. He was not part of the conversation. And i appreciate it, but you know, were limited on time. Tell me who at d. E. A. Pushed this bill at the time. Sir, i dont have a name for you, but i would like to get back with you if id make those determinations. I had id like to do that. Here is what it looks like to me, i know senator hatch and senator whitehouse and i dont believe that for a second that they would support legislation over d. E. A. s objection that would hurt people. I dont believe they would do that i think d. E. A. Or somebody d. E. A. Said this was a good piece of legislation and now all of a sudden, we cant find them with a map or a search party and i just want to know who did. And if everybody was so opposed to it at d. E. A. , why werent they raising all matter of hell . When she has a chance to think about answering your question, she can answer in writing for you. Do you want me to shut up now, mr. Chairman . I was on a roll. [laughter] well, were going to have a second round so youll get another chance. Ill take that a yes and apologize for going over, thank you, miss ashley. Senator durbin. Thanks, mr. Chairman. Miss ashley, thanks for being here. I guess it came as a shock to me there was testimony in this very room by the acting administrator of the Drug Enforcement administration and senator kennedy i learned something i didnt know, the education of a senator is a daunting task and what i learned was that there was a federal agency which controlled the amount of opioid pills, the number, the volume, each year. They established quotas and they told pharmaceutical Companies Across america, these are how many you can produce. It turns out that for a long period of time, the pharmaceutical companies had been demanding more and more and more. Ive got a chart here that shows a couple of the most popular of the opioid pills. What happened to the production of them. And in order to hit these levels of production for hydro codone and oxycodone, they needed the area na you worked for and they testified about the terrible Opioid Crisis and when i pinned them on it, they were given the green light for the production of the opioid pills and pharma in general was asking for more and more and more, i said to the head of the d. E. A. , i think youre part of the problem. He said yes, we are part of the problem. Were talking about a unique situation where the Drug Enforcement agency is telling america out to get drugs out, in one office and an another office telling how to make more drugs. Currently we produce 14 billion, billion opioid pills a year. Enough for every adult in america to have a one month prescription. Now, i know there are people with chronic pain and illness who need it and i will fight for their right to get it, but a one month prescription for every one of us in this room and every adult in america . Common, as they say in one of those sports shows. And you also, i think what brings you here today is a question about distribution. I represent and know pretty well a county called Madison County in illinois. 2014, 14. 4 million oxycodone and hydrocodone pills sold in Madison County, illinois. Thats 54 pills for every resident of Madison County, illinois. West virginia, a single pharmacy in a town of a population of 392 people received 9 million hydrocodone pills over two years. Population 392. 9 million pills. Who is the cop on the beat . Drug enforcement administration. And the question is whether or not we did anything to make your job easier or harder. I have watched the 60 minutes segment many times and i couldnt agree with senator kennedy more and my colleagues, i cant believe any of us voting for this felt we were making it easier for people to distribute an indefensible level of these drugs, but it happened and i gue the question that were basically asking you is, now that 44 attorney generals say did we make a mistake . Did we make a mistake . Should we repeal the insuring access of Drug Enforcement act to make sure you have more tools and you can get tougher with those who are clearly abusing the production and distribution of these pills . Thank you for the question, senator. Again, we have tools and we have a bucket of tools, and the immediate suspension order is just one of them. We have not been hamstringed in a manner that we could not do our jobs. We look forward to the committee if theres something done with the current administration. And well continue to work within those bounds. Let me see here, the d. E. A. Ordered suspension orders, 65 in the year 2011 and this was in the earliest stages of our Opioid Crisis. Five in 2015, nine in 2016, i think the cops on the beat are not spending time looking for criminals here. If we are truly dealing with an Opioid Epidemic with numbers that ive just read to you, these suspension orders dont match up to that rhetoric, dont tell me this is killing americans right and left, almost 2000 last year in my home state of illinois, and then tell me that nine suspension orders in the year 2016 shows that you have all the tools that you need . I dont buy it. I dont buy it at all. Either youre not doing your job or you dont have the authority to do your job. Im speaking generically as an agency, not about you personally and thats what i worry about. Senator, this is, again, this is just one tool. Certainly were using other tools to do our job and we have a dedicated work force as im sure ive met with you a couple of times and had the discussion about quota, and yes, it did rise over several years under, you know, prior management at the time, it was deputy administrat administrator, ands quota is determined by the statute, i dont know what he had in front of him to make those determinations and im sure they were very careful determinations, but when i met with you, sir, we had discussions and we went back to the table. I met with you and withlso a our previous administrator, chuckrosenbg, we went back to the table and we had discussions and we have lowered it, the first year. Ill just close, mr. Chairman. Were not dealing with a run away virus here. Were not dealing with ebola, were dealing with decisions by people in your agency and others in terms of the volume of production in america which led to this epidemic and the producing and distribution by doctors and pharmacies and inadequate, thats why were sitting here today. Senator. Thank you, police ashley for being here and testifying. I want to follow up on some of the questions that senator kennedy asked you and youre just here testifying on behalf of the d. E. A. Did the d. E. A. As an agency take a position when this legislation was pending before congress . Again, i hate to keep repeating myself. I was not present during those conversations, but its my understanding, yes, concern was expressed the entire time. Okay, your personal knowledge, youre testifying on behalf of an agent. Yes, sir. So presumably somebody at the d. E. A. Knows whether the d. E. A. Took a position on this piece of legislation. Yerz. The agency as a whole has a collective memory. The agency knows. Yes, sir. How would that position have been expressed . I believe it was expressed and discussed in discussions through the department and to the initially working with the house and also with the Senate Judiciary committees. Did the department of justice express a position on this legislation . I believe that, yes, yes, sir. Did they support this legislation . In the end, they support the ultimate language. I believe that concern of how the bill would affect how we conduct our certifications was expressed throughout. I just want to understand. So, the department of justice supported the legislation in the version that actually passed, is that correct . Yes, sir. And the d. E. A. Supported the legislation in the version that actually passed . Yes, sir. What advice did the d. E. A. And the department of justice give president obama on whether to sign this legislation . That conversation would have been through the department of justice. Im not certain what it was, but i know that Technical Assistance was provided on the final language. All right. So, is the legislation working . Set aside whether d. E. A. And doj and wther the entire executive branch was supporting that legislation. That aside. Were a year into it and is it working or are inunintended consequences . We were continued to issue isos as in the past, it didnt hamstring us from doing that. The concern was distributes and that remains to be scene under the case and is that a problem, is that a lack of Legal Authority . Why havent you, what are we missing . Actually, sir, the distributors and manufacturers that we were looking at that were doing the most shipment much drugs had resent they had recent actions taken against them, and the other distributors, they, you know, theyre close enough knit community, its a deterrent effect that kicks in, but the larger distributors, you know, the big three we call them, they had recent action taken against them. So since the implementation of the iso, theyre already under memorandum of agreement to be in compliance with the controlled substances act. So, it hasnt been warranted, so far. So if im understanding it, there hasnt been a factual predicate, there hasnt been a need for it, correct . There hasnt been a test case, sir. What is not working about this legislation, if anything . Congress is trying t understand, if legislation was enacted that made things worse, we would like to know that, but you all are on the front lines dealing with it and we need your expert judgment to help us in assessing that. So the concern now prior to the legislation, we were in a preventative mode. We want to stop this distributor from making shipments before harm is done. We could identify violations of the controlled substantial act solely that the distributor committed. The current legislation requires that we have a substantial likelihood of immediate death, bodily harm and abuse. And other than that, the increased potential for diversion. Does the d. E. A. Believe this legislation needs to change . D. E. A. Along with the department of justice supports a change in the legislation. What change does the d. E. A. Support . Now, so there is where i have to be careful. Im not an attorney so i dont want to throw out the potential for language that could make a worse about you, im happy to continue as we have many times worked with this committee to have the language. Im going to ask you if the d. E. A. As an agency has a position supporting a change in legislation . I would askhat you convey that to mendy cleagues would be interested in writing. Es, the specific language you believe would work better. Yes, sir. We cant understand what youre requesting if the agency doesnt request is clearly and with language attached. Yes, sir, i will do that. Thank you, miss ashley. Senator whitehouse. A followup on senator cruzs point. We had these conversations with the d. E. A. When the bill was developed and we reached an agreement, the d. E. A. Signed off on that was approved by the administration, that was approved by the attorney general of the United States on the recommendation of the attorney general of the United States and signed into law. So, forgive me for just a bit of frustration when we are now in a situation in which the executive branch in the form of hhs, which is to be advised by you all at dea, is under a legal obligation to do analysis of what changes are needed in this bill and has refused to do so, despite being required to by law, and we have the testimony now of your agency, that you have no proposal, despite a recommendation that there be a change. And thats a little tough for us to work with. We are happyo try to do this, and to try to make sure that we gett right, but at the moment the state of the record is that d. E. A. Signed off on the bill as it is. D. E. A. Has no proposal to change it and hhs refuses to do the report that congress commanded. That doesnt give us a great position. So, i hope that in whatever way you can, you can friday to get these basic questions answered so we can proceed. No, your testimony has been that you have a bucket of tools and that you have not been ham strung by this piece of legislation because you have that bucket of tools. So let me take a minute and just go through that bucket of tools and make sure im not missing any. One is letters of admonition. And the second is you can call administrative hearings and you can drag that distributor in to answer for their conduct, can you not . Yes, sir and those would be informal hearings. And you can require a memorandum of understanding to be entered into by a registrant as a resolution of a dispute with d. E. A. , correct . Thats correct, sir. And you can even demand voluntary surrender of the license and give it up and cash in and go away. Yes, sir. You can go to court if a registrant is recalcitrant and get an Administrative Law judge of yours, to issue an order to show cause requiring them to defend tir licee, correct . Yes, sir. And that puts immense pressure on them, even the threat of that to come into compliance. Yes, sir. And the ability to push for show cause is unilateral on your part. Providing evidence, yes, sir. And you can bring Civil Penalties and civil action, and go into lawyers and court against them. Indeed, in 2017 you hit a record, in Civil Penalties against distributors, correct . Im not going to hold you to correct. Yes. And its been against diversion. Yes, sir. And finally criminal action. Its my understanding you make about 1500 diversion cases a year in the criminal courts in which you have the requisite intent to show and somebody is actually inks is aed and goes to jail for criminal fines levied against them for that. Yes. 1500 a year. Average, sir. If you have that authority, in the context the last time you did an iso with contributor or manufacturer was in 2012, correct . Yes, sir. And lets just say you were hesitant in 2015 in the agency because the bill that was coming up in 2016, but so lets go back two whole years to 2014. You only did eight isos in that whole year compared to 1500 criminal cases, correct . Yes, sir. So it doesnt sound like a center piece of your enforcement bucket of tools. Sir, if i could say that most of the isos and orders of show cause on physicians in pharmacy, historically its been on distributors and manufacturers. And theres a reason for that. Lets focus on distributors, thats this legislation. Usually distributors arent a a factor, really, in the direct diversion of pills and millions you find that they have lost control of their inventory, and are slipping stuff out to the public, what theyre doing, mostly in these cases, as i understand it, is failing to report to d. E. A. Where drugs are going in inexplicable numbers. I mean, how often do you see a diversion case where the opioid pills are directly leaving a distributor into the hand of the illic user . It doesnt, sir, but what happens, the distributor is responsible. Correct. To Due Diligence. So its a reporting and Due Diligence issue and not diversion. It leads to potential. On the part of the doctor, the pharmacy, whatever is happening down street where the opioid pill meets the consumer. And so do you have recommendations, were eager to hear them. I will conclude by saying its incredibly frustrating to have the agency that signed off on this and supported all the way to the president of the United States now needs a chaek and is unable to articulate what the change is and the hhs which is under legal obligation to report to us on how this is working and what we should do refuses to comply with the law and well continue to mike inquiries. Thank you for your service. If they are opposed to, and not having done yet. If we pass a law, they ought to make the report, they ought to make a report. A date on it. Are you saying theyre never going to do the report . I have no idea. Theyre eight or ten months late right now and theres no sign of it on the horizon. It would be great if it was done timely, but i think whats important is that we have the report that the law commands. Senator and be nice that it happened in the time frame na the law commanded. Thank you, mr. Chairman. Miss ashley, ive long worked on these issues including first passing with one of the drug takeback laws with senator cornyn. Im a cosponsor of the bill to appeal the insuring patient act, effective Drug Enforcement act and i guess id start with this. Do you have reason to believe that the d. E. A. Would have issued more isos had the law not been enacted . Its difficult to answer, senator. I dont believe and the reason i dont believe so is when we conduct investigations, we take them where the evidence takes us, so that would be. So they happened to be a drop off as the crisis was growing . For immediate suspension disorders, when you talk about the distributors, theyre used very sparingly. Its become a unique thing. So, lets go with backo the numbers. I ha that the d. E. A. Issued an average of more than 40 suspension orders a year. That abled them to stop the shipment and then the d. E. A. Issued seven isos. In 2014. 2014. Since 2014, yes. And i had i understand there has not bb one issued to since 2012. There a reason only pharmacies and practitioners are the subject of the recent isos . I can explain when investigators engage with distributors and manufacturers, because we have a responsibility to make sure that the patients have access. Weve wanted to keep them in business and we want to bring them into compliance. Its only the most egregious that we would ever use to order an immediate suspension order for. There have been no manufacturers, neville they should go after . We may have engaged, but theres a different tool that senator whitehouse mentioned and to do to bring them into compliance. I understand in addition to the immediate suspension orders asenator whitehouse mentioned the d. E. A. Has other norths through which they can suspend the drug km. It you elaborate on that on the immediate suspension and d. E. A. Enforcement efforts . The immediate suspension order is a tool that d. E. A. Would use and reveal when theres something egregious going on. In the sense that we would need to stop. Its not in the Public Interest for you to have a registration and this needs to be satisfiesing immediately. Theres a process behind it. Drafted. Theres still an opportunity for a hearing. Theres still negotiations and conversations with the prosecutors and defense attorney. So, its still a process, it didnt happen immediately as the word says, but its always been used sparingly. Although my intention, with changes to the 2016 law at this hearing, im interested in hearing your views on the other provision of the law for the opportunity for corrective action plans to the d. E. A. Prior to having their license revoked. What is the d. E. A. s position on this and how frequently has it been passed in the last year. Opposition on it, its redundant and unnecessary and the reason is, when we engage with registrants, were having the conversations. The opportuni for mitigation and you know, remedy have already occurred. We always try to bring a registrant into compliance, but we have that conversation sometimes for several months so piatt with time we get to the point. Were issuing an order to show cau cause. And 194 million in Civil Penalties in 2017 thats more than the Civil Penalties in the pass years combined. Can you tell me about the recent increase and why the d. E. A. Has been pursuing more Civil Penalties . Actually, senator, it wasnt more registrants. One registrant paid a fine of 150 million. Again, the second one paid additional fine. Do you think there are others out there that should be paying that kind of money . I think that theyre on side of disclosing evident that support it, absolutely. It seems the idea that would ask for this. There are three distributors that mostly are the market on the opiate drugs. What are the other two . The other two are other cases against them and other types of actions. Are those pending right now . One is, one is not. Okay. Senator blumenthal. Mr. Chairman, a lot of the discussions seems to come down to unintended consequences of this law and one of the chief unintended consequences seems to involve the term substantial likelihood. Would you agree . Yes, and also the word immediate and also debts i was going to come to those issues as well, i thank you for pointing them out. Im sorry, sir. Under the law that were here to discuss, the d. E. A. Can shut down drug shipment immediately whenever it includes that therapy is a quote, unquote, substantial likelihood, that failure to do so will result in some harm, including the harm of illegal drug use or other kind of harms. I wonder if you could give us an idea of how the d. E. A. Describes the term of substantial likelihood and also some examples of situations where the d. E. A. Would want to shut down drug shipments, but it does not believe that there is a substantial likelihood. Some real world experience as to what the definition of the term is and how it has, in effect, finished your ability to stop the shipments . So, the mission of a diversion investigator is to detect and prevent diversion while at the same time assuring access to those that need it. So what the statute did was take away the prevention piece of it. We would want an immediate order, stop the shipments and take away the d. E. A. Registration so no further shipments could go and and you can still do it you have to meet a different standard. My question to you is, how in practical terms give me some examples. You face the situation where i face the situation where a distributor willfully, with great knowledge, avoiding the controlled substantials act, not reporting suspicious orders, not exercising Due Diligence, constructing shipments structuring shipments so they can remain under d. E. A. s radar. For that, those would be groundsalone, solely too an immediate suspension order. With the new legislation, i would need to go upstream from the harm and thats a death or bodily harm or abuse. I would need to work backwards. And so a substantial likelihood of some farm. Yes. And some like before. We were aiming to prevent diversion. Because its forseeable if drugs are verted and they get to someone who should not c them. We always use a tool as a preventive member. And those shippers who are stopped likely to have had violations previously . Likely . Its possible, yes, sir. My guess is that the distributors who would be shut down were repeat offenders, correct . Its elevation wouldnt you be able to use this law showing the harm previously arising . This law we will, this is the law of the land. So d. E. A. Is going to continue to work within, you know, what we have. Were going to continue the use of resources. If thats necessary, absolutely we would do it. What we would like to do is continue using the use of legislation as it previously was to prevent you want to go back to the legislation that existed previously with the lower bar or standard . With the standard in which we can prevent diversion. And let me ask you in the short time i have remaining, should congress be providing more funding for this kind of effort . Isnt that as big an obstacle to you in terms of diversion control and prevention as you rightly highlighted as this legal standard, and the change in the legal standards . Additional resources, sir and additional tools always good to support Law Enforcement, i appreciate that. If congress could do one thing to crack down on illegal diversion, which would you recommend, more funding or a change in this law . Thats a tough question. Well, if its a tough question, i gather. On both. Funding is as important as the change in this law . It is, sir. Thanks, mr. Chairman. Thank you, mr. Chairman, obviously, if we need to make changes to this law you have testified we need to know what specific changes we need to make, and in addition, mr. Chairman, if you could go after hhs for producing the report that theyre supposed to have produced. Senator whitehouse has gone through a list of other stools that you have testified because weve been focusing on the number of isos and that number seems to be that criminal action and et cetera, et cetera. Has the d. E. A. Made use of other tools over the course of time that you can provide to us . A dramatic increase. You say that isos are going down and so, there are other tools, 1500 criminal cases. I dont know, got compared to when . This sounds like youre doing going in the right direction, but how does that number of criminal cases, position how does that compare over time to the number of cases that d. E. A. Has brought. There are several that grow approtec neek, i would need to get back to you to demonstrate it because theres so many of them that i can tell you, yeah, we have more loas. So, is it your sense or you may not have the actual numbers. But is it your sense that the d. E. A. Has increased the use of other tools because we have an ongoing and growing Opioid Crisis in our country . So, please provide us with some kind much information along those lines. Im interested in this chart though as provided to us by senator durbin and just thats this chart that they had and it looks as though there is a decreased number of requests from manufacturers for drug increased drug production. Is this just a temporary decrease . Because there was a pretty high approval rate. Whats going on that leads to this lower drug production in 2017 and 18 . So, senator, were bound by statute when we develop the aggregate quota and every year we start over fresh and make that determination based on the facts before us, what the United States, the medical and scientific need and all types of factors and inventory and that sort of thing. We met with senator durbin, actually, a couple of times and had these conversations with some other senators present and in making those analysis, we termed and for the 2017, a tq that it was possible to reduce it and that was an actually an easy one, that was a cushion put on for emergency purposes only. For 2018 production quota, we were able to reduce it again and thats again, looking at whats required by statute and doing some critical analysis on whats necessary. And well do the same thing again for the 2019 aggregate production quota. Thats good. I think thats going in the right direction. Because as senator durbin indicated, its hard to believe that our country needs 14 sh billion opioid tools per year. Pan i and i really dont know how you determine what the country needs, but the fact that were in a crisis and approvals are going down. Thats a good thing. I wanted to ask you about your 360 strategy for attacking the Opioid Crisis and hawaii has been relatively low key weve been spared the Opioid Crisis, but the state focus six years, prevention and public education, data, pharmacy based invention, supporting Law Enforcement and responders, so it sounds sort of le your0 strategy youre in a number of states. So based on ur experience with your 360 strategy, what are the most effective ways for states or, in fact, cities to combat the Opioid Epidemic and ive listed things that hawaii has come up with. The most important thing that our agency has been focused on is engagement and enforcement. Its going to be necessary especially when this comes to those who handle our those who legitimately handle controlled substantials. Continuing our engainingment, getting out to anyone listening, to the public, to our registrants and also, enforcement and thats making partnerships. Im running out of ive gone over i wanted to ask whether theyre in hawaii. Do you work with people in hawaii . Yes, it have. New, mr. Chairman. Weve had at least two, senator kennedy and senator hatch, and i hope we can limit it to five minutes. Well start with senator hatch. Weve got a second panel weve got to get to and give them time, too. Id like to start the second round raising an issue of concern. Its come to my attention, theres a move afoot by trial lawyers to make pharma the next big tobacco. Discussing plans to bring multistate class actions ainst dru manufacturers and distributors and turn them into villains. One recent articles about this effort quoted one of the leaders of the effort by saying, the vilification of this industry has not even begun yet. This litigation will vilify them and wont make the Companies Look like legitimate business people, it makes them look like they take advantage and a lot of people who died from their products. Its my understanding some of the most vocal opponents of the legislation were discussing today. Some of the loudest voices calling for repeal are serving as paid consultants of the trial lawyers suing the drug industry. That doesnt mean we should discuss their views, but what i dont want to happen is this committee to be a vehicle for trial lawyers pursuing a carefully mapped out strategy. I understand that these trial attorneys intend to get the state attorney generals as well. Lets be cognizant of some of the other things going on here. Now to my questions, i have here another chart right here. This shows d. E. A. Show cause orders over the last nine years. Na was as far back as i could get the data. Again, the vertical dotted line on that chart indicates that when the insuring Patient Access act passed, i had id like to make two quick points. Rather than the show cause orders, actually increased by nearly 40 and second, d. E. A. Issued more show cause orders this year than at any time in the last nine years. Simply put, the ensuring Patient Access act has not caused a slow down in show cause orders. Now, the ensuring Patient Access act showed imminent danger where one didnt previously exist. Let me ask you, why is it a problem for d. E. A. To have to meet a publicly known clearly defined standard when issuing an iso . Isnt it appropriate for individuals and companies to know the standards theyre being held to . Senator, the new legislation in one manner doesnt apply to the orders to show cause, it only applies to the immediate suspension in other words. And thats the corrected action plan where registrants are able to come back and come back to d. E. A. And, you know, explain what their recommemedy is or chs to the violation disclosed. At a house meeting back in october. Neil daughterty was asked whether he agreed if congress repealed the Patient Access act and quotes, didnt supplement it with something else, then the same thing that raised concerns from a whole host of constituencies would come to bear once again and he replied, yes, sir, yes, sir, i believe we need to mechanism at that level with respect to that tool, unquote. Do you agree with mr. Daughterty, simply repealing the Patient Access act and nothing for imminent danger is not a viable course of action . Senator, in our collaboration, in d. E. A. s collaboration with doj, we believe that a change should be made, but, now, how, what that looks like in the end. Its going to require additional conversations, sir. Okay. Chairman grassley invited d. E. A. Chief Administrative Law judge john mull rooney who testified at this hearing. As we know, judge mull rooney has written an article sharply critical of t patie access act and this has formed the basis of much of the criticism and the law. Its my understanding that the agency declined to allow judge mull rooney to testify because, both, Administrative Law judges are neutral finders of the fact and administrator law judge is not in a position to testify in his personal or official and my question, how do you skwa i remember this with the fact that judge mulroney is being quoted extensive ly from the agency. If an Administrative Law judge is not in a position to comment on legislation, why is he in a position to write a law review article excoriating a law that he himself is tasked with adjudicating. These are legitimate questions. Did d. E. A. Authorize judge mulroney to publish his article . I can tell you the d. E. A. Has a public review boardment im not aware if judge mulroneys publication what was the d. E. A. s reaction when they saw the article. As a whole i dont know. Okay, its a common practice for judges to opine on merits of law theyre adjudicating, why or why not . Sir, it may be, but it has to we have a process within our agency where would be approved, and once the approval is met, that can happen. Mr. Chairman, before closing this i ask for unanimous consent to enter several documents into the record. The 2014 pharma survey. Two gao reports, and from representative marino, describing origins of the bill. And letter from the bcu professor describing troubling conduct by d. E. A. Diversion control agents and paper copies of these two charts and i also unanimous concept to enter into the record, two records from efficacy groups excomplaining r plank the need of this the second of which is signed by 31 organizations. Without objection, so ordered. Senator kennedy. Ms. Ashley, i want you to thank you for coming today. Thank you, sir. Youre a brave american. You ought to ask whoever made you come for a pay raise. Who else is here with you today from the d. E. A. . Could you just raise your hand . We also hear from the Justice Department. Welcome to all of you. This excited by senator durbin, miss action. From kermit, West Virginia, 9 million hydrocodone pills over two years sent to a single pharmacy in a town of 392 people. Were you familiar with that . Yes, i am, sir. Its breathtaking. The American People are watching this and let me tell you what theyre thinking, in my opinion. They dont care about the meaning of the word immediate immediately, or imminent danger, or theyre not interested in the ico or the d. E. A. Or the csa or nba or the nfl. What they want to know is how a federal agency or agencies allowed 9 million hydrocodone pills over two years to be sent to a single pharmacy, not five, not four, not but not three, but one pharmacy in a town of 392 people. Thats 23,000 pills per person. Thats 31 pills a day for every man, woman and child in kermit, West Virginia. How could you allow that to happen . You know what the people of america are thinking . They dont care how many lawyers can dance on the head of a pin. They want to know how were allowing this to happen. Theyre asking, what, what planet did we all parachute in from . How could the d. E. A. Let this happen . You talked about all the tools you had. Were they not sharp . How could this happen . Go ahead. Sir, i hear you and i share i truly share your sentiment and so do the men and women of d. E. A. I have here with me today mike sutton hes a senior in check and i hold him very close. And what is his name . Omari. Omari, welcome. And these kieptypes of thing and when we read the news reports of and the age group, 18 to 24 it breaks my heart. Miss ashley, i agree with you, but how did this happen . I can tell you that we have processes. We have worked very hard to change those processes. Could we do some things better, absolutely, sir. We have to work heard. We have work harder, this is instant. I heard the senator say there are 14 billion pills distributed in the United States every year. There are 323 million americans. Thats 43 pills for every man, woman and child in america. Yes, sir, and i agree with you. Well, tell me what we need to do to stop this . We have to do everything possible, what were doing today, having these conversations and developing different laws and tools that can help the d. E. A. And all of Law Enforcement. I mean no disrespect and i meant what i said. I am so pleased you would come today, but i dont want to keep having conversations. Id like you to have whoever makes decisions at d. E. A. And justice to send me a letter and say, this is what we need to do to stop someone from sending 9 million hydrocodone pills over a twoyear period to a single pharmacy in a town of 392 people. Yes, sir, im happy to do that. Yes, sir. Send a copy of that letter to me, too, would you, please . I wouldnt mind having one, too. Yeah, okay. Miss ashley, were at least for now, were done with you. And youve been very brave coming here and we know that a lot of things that arent in your hands, youve tried to answer because you are the witness, youll also maybe receive some questions in writing from us or people that arent here today, so, they should be received in at least a week and then a if you do get questions inwriting. We thank you very much. Yes, sir, thanks, senators for your time today. Would the next panel come, please, and while the next panel is coming, im going to introduce the next panel, even though you arent seated. Our first witness is jan chambers. Miss chambers is the president of the national my fibromyalgia organization and the mission is to Issue Advocacy programs regarding to care, scientific research, diagnosis and treatment for people suffering from those diseases and chronic pain. Our second witness on our panel is attorney general brian farsh, served as attorney general for the state of maryland since 2015. Through his position as attorney general for maryland, he represents the interests of the state of maryland in cases involving community safety, environment damage, consumer fraud, predatory Business Practices and civil rights issues. Prior to his position as marylands attorney general, he served in the maryland General Assembly for 28 years, while also working as an attorney in private practice. He served five terms in marylands state senate and four terms in iowa, or in the maryland house of representatives. Or house of delegates. Next we have dr. Carman the catazone. The doctor is the executive director of the National Association of boards ever pharmacies and secretaries. Associations, executive committee. In this capacity, he is responsible for the oversight of the National Association of board of pharmacies, delivery and quality of programs products and Services Offered by that association. He is also responsible for assisting the executive committee of the nabp, fulfill its governance functions and he is also a registered pharmacist. And our last witness, john gray, president and ceo of Health Care Distribution alliance and held these positions since 2004. He is responsible for oversieg all operations and activities of the Health Care Distribution alliance, which is an organization that represents primary pharmaceutical distributors. Were going to start with you, miss chambers and go the way i introduced from my left to right. Thank you, sir. Thank you, senator grassley, senator feinstein, senator hatch, to allow me to testify and to accomplished members. Committee and thank you for having this hearing. In december of 2005 my world changed after hysterectomy surgery and electrifying body and i hurt everyone, and curled up on the couch and additional problems. Nobody could touch me because of so much pain and lay with pill less to support my arms and legs were touching each other. And waiting for the days past. And people cannot just lay and hope for the pain to stop. I couldnt find anyone to find out what was wrong with me. Were going to break away from this hearing momentarily to brief bring you a brief pro forma session from the u. S. Senate. The presiding officer the senate will come to order. The clerk will read a communication to the senate. The clerk washington, d. C. , december 27, 2017. To the senate under the provisions of rule 1, paragraph 3, of the standing rules of the senate, i hereby appoint the honorable tom cotton, a senator from the state of arkansas, to perform the duties of the chair. Signed orrin g. Hatch, president pro tempore. The presiding officer under the previous order, the Senate Stands adjourned until 11 30 a. M. On friday, until 11 30 a. M. On friday, the senate is back january 3 with 2 new senators, doug jones of alabama, and tina smith of minnesota. When the senate returns, live coverage on cspan2. Now we take you back to the Senate Judiciary Committee Hearing on the Opioid Epidemic. Within a couple of years. Pharmacies began turning legitimate patients away asking for cash and only giving partial fills. Patient organizations begin hearing about wholesale and midlevel distributors, pharmacies and prescribers unsure why the being investigated. Shutdowns the pharmacies and doctors offices were happening. Patients were scared and in pain and doctors reported dea was Holding Meetings with prescribers to one them about overprescribing. Doctors reported the red flags were not clearly defined and ambiguous. Doctors begin requiring random and frequent urine test and confining contracts the patient but where and when they could get the prescription filled on which days. At meetings doctors told me they were nervous to treat patients for chronic pain because it did not go might be lying to them to get a prescription for opioids. They resented being defensive to protect their livelihoods and that the families were fearful of the making of the state and going to jail. The general response for the primary doctors was to stop treating people with chronic pain. Insurance Companies Including cms are squarely to share the blame for the skyrocketing use of prescription opioids rather than nonpharmacological treatments. Paying for opioid especially a generic opioid is simply cheaper than paying for integrated health treatments. Steps set people back with seris pain and cost harm to them by increasing the symptoms of their disease, chronic pain. Doctors pointed to the ruined reputations of t colge under dea investigation. Two doctors under investigation asked me to help them find of the doctors to take care of their patients. I never could. The cdc guidelines for prescribing opioids was released with great fanfare and press release on a tuesday in march 2016. These recommendations not lost no statutes state legislatures are implementing them as it they are hard fast Standard Practice rules. This is significantly harming people who need higher doses of prescription opioids for legitimate medical reasons that are documented between a doctor and the patient where those decision should be made and not at the pharmacy window go with insurance benefit managers. The National Paint strategy was quietly published by hhs in the federal register on the following friday afternoon in march. This left little death in the minds of millions of how much they dont matter to federal officials. Recently a staff member called five primary care doctors offices in utah to find a doctor to help chronic pain on her chest wall and the feeling of and while this. All of them said issue seeking care for pain that theyre not taking new patients. Then she found a lump in her breast and last which had a double mastectomy for states to Breast Cancer which metastasize to her lymph nodes. What is of increasing dea investigations cost the Chilling Effect on doctors willing to treat patients. Patient access to care with significantly affected after the rescheduling of hydrocodone from schedule three three to two and october of 2014. At the end of the fda hearing, 12 of the 29 member said their concerns about the impact of chronic pain patients and i contacted fda Deputy Director about monitoring the unintended consequences. After several minutes passed with no action by the federal government are Nonprofit Organization sponsored a National Survey which is included in my written testimony. Thank you very much and now general. Mr. Chairman, Ranking Member, senator hatch im very grateful for the opportunity to be a today and to testify. Last month as you know 43 of my colleagues and i sent a letter to leaders of Congress Regarding the ensuring Patient Access and effective Drug Enforcement act which i which is referred to as the act. The act has been we believe a a step backward in our collective efforts to prevent the unlawful distribution and diversion of opioids that have contributed to our National Epidemic of drug addiction and death. The dea is of vital federal partners for all of the attorneys general across the country. It needs a complete set of tools to be effective in this struggle, in interview the act handcuffs the dea. It makes it more difficult to stop dangerous and illegal shipments of narcotics. The act also gives additional protection to those suspected of illegal activity. It requires the dea to evaluate corrective action plans instead of moving swiftly to suspend or revoke the registration of bad actors. The consequences of the epidemic include as has been noted in part, in 2016 more than 2 million americans were suffering from addiction to opioids. Since the year 2000, about 200,000 americans have died from overdoses of prescription opioids. Another 100,000 from other illicit drugs like heroin and fentanyl. It keeps getting worse. In this year, 2017, we are projected to reach 70,000 deaths. Thats as many deaths, thats more deaths than americans killed during the entire vietnam war, just this year. The epidec rages on, despite clear evidence that the prescription distribution and manufacture of opioids in excess of medical needs is contributing to its severity. The letter from the state attorneys general put it last month in part as follows. The act effectively strips the dea of admission critical tool, namely the ability to issue an immediate suspension order against drug manufacturer or distributor whose unlawful conduct poses an imminent danger to Public Health or safety. Under the controlled substances act, the dea has authority to issue suspension orders where the dea find theres an imminent danger to Public Health or safety. The act altered this standard definition by requiring a substantial likelihood of an immediate threat of death, serious bodily harm or abuse of a controlled substance, and this language has essentially or effectively eviscerated the deas ability to act drawing the standard so narrowly that in the words of the judge has been cited often this morning, it is now quote all that logically impossible, end quote for the dea to suspend a distributor for failing to comply with the law. The act also further constrains deas effectiveness by giving manufacturers and distributors a new opportunity to avoid sanctions for engaging in unlawful diversion. The new law allows a registrant to file a corrective action plan prior to an appearance for show cause proceeding. Dea is required to first give the manufacturer or distributor at least 30 days to prepare a corrective action plan, and then to consider that cat in determining whether enforcement proceedings should continue. In effect it affords lawbreakers leverage to obtain additional chances, and as the judge points out it is, can mandating that Law Enforcement authorities allow shoplifting suspects caught in the act the opportunity outline how the intend to replace the prolonged items on store shelves. I remain mindful of the imperative that in fighting this crisis, we must be careful not to over correct. We must not impede Patient Access to Prescription Drugs that serve immediate and legitimate medical needs, but my colleagues and i believe that the act from last year does not advance this important goal. It just diminishes deas ability to prevent unlawful opioid diversio we face as been said a number times already this morning a Public Health emergency. The countrys success in defeating this threat depends on all of us, state, local, federal authorities working together effectively. We are fighting a Public Health conflagration of epic proportions, and i believe that last years act stands on the fire hose. I urge you to repeal it. Thank you very much. Thank you, general frosh. Now dr. Catizone. Thank you, chairman grassley, Ranking Member feinstein and senator hatch. Thank you for the opportunity to inform the committee of our concerns about the law and the need to repeal or modify the law. Id like to modify my comments this morning and address some of the issues which the Committee Member said raised. First, it was not one of the groups simply jump on the bandwagon once the Washington Post or 60 minutes article hit. We said our concern a letter to senators grassley and leahy back in september 5, 2014 and in those letters we commented that the law would have a detrimental impact on the protection of Public Health and do irreparable damage to enforcement ability and authority of the Drug Enforcement administration. The ability to act decisively with an imminent gauge the Public Health or safety exists is critical to protecting Public Health. It is an enforcement action legislatively mdated to the state boards of pharmacy and utilize repeatedly and effectively by the state boards of pharmacy. The defining of imminent danger to the Public Health or safety by the epa, dea or the law is concerning from the perspective of state regulatory agencies that successfully utilize these provisions as formally defined in a controlled substance act to act with expediency, and in the foremost interest of the public protection. Regard to the date in which the committee has supplied, in terms of the actions taken against wholesale distributors, the immediate suspension orders and the fact that the word orders of 2012 forward, and the fact is only a small percentage of orders taken against the wholesale distributor industry, from a wholesale perspective begs the question where was the problem . What was the regulatory problem that mandated that the definition be changed and that there were problems with access to pharmacists, pharmacies and patience . As a pharmacist was in this industry all the time we heard those concerns and we saw what some of those problems were that it did not appear to be the definitions of imminent danger that were contained in the original controlled substance act and later amended by the new act. Also ask an Expert Witness for the dea and u. S. Attorney offices across the state, i can personally attest the cases ive assisted with were unequivocal instances of the egregious activities by wholesale distributors, pharmacists and prescribers that threaten the Public Health and were ultimately responsible for the deaths of patients. In those cases, the access to controlled substances for legitimate medical purposes and legitimate patients were not issues and would not have been interrupted by the changes that were proposed and enacted by the act. Fortunately these cases represent the majority of practitioners and have been used, nearly 700 wholesale distributors who are verified wholesale distributor accreditation program. Through that program with come to better understand the wholesale distributor industry. Our collaborative event for witness states and significant number of wholesale distributors who have become accredited allow was to competently represent that those distributors who achieve accreditation have processes in place to comply with the controlled substances act and regulations and are determined to be comply with all federal and state laws. Additional consequence of the enactment of the law the issue of suspicious orders. Once again in the cases ive been involved with as an Expert Witness there was no question as to what constituted a suspicious order. State boards of pharmacy, many of which require the reportingf suspicious orders, consistently conveyed to an apb has reported a suspicious orders to them is simply an obstetrician of information and attempt to break the state boards of pharmacy and meaningless paperwork. In situations reported by the state boards of pharmacy, the reporting entity makes no effort to distinguish a legitimate suspicious order. The reporting seems be nothing more than a statement to the boards of pharmacy saying we have complied with reporting suspicious orders by reporting everything and anything. Now you can figure it out. Nabp believes that this is one of the areas that need to be modified by a change in the law. In closing, nabp appreciates ae opportunity to appear before the hearing today. We offer our assistance to the committee and strongly urge the repeal or extensive modification of the insuring Patient Access and effective Drug Enforcement act, specifically which change would make in response to questions are eliminating the corrective action plan language and changing the definition of imminent danger to the Public Health and safety back to the original definition that is in the controlled substance act. It is utilized by all the state boards of pharmacy and has been utilized for years and years. Thank you. Thank you, dr. Catizone. Now mr. Gray. Push the red button. Im sorry. There we go. Good morning. Chairman grassley, Ranking Member feinstein, thanks for the opportunity to coming to do this today to talk about 483. Hda, represent hta and americas 35 primary wholesale drug distributors. A vital link between manufacturers, pharmacies and healthcare providers. Our industry primary mission is to offer the most secure and efficient supply chain in the world as logistics experts, pharmaceutical distributors deliver all types of medicine. Specially produce, cutting disease treatment, cancer medicines and more to license Healthcare Professionals for their patients. Distributors were closely with our supply chain partners, regulars including dea, fda and the 50 states. Of the distributors do not manufacture we dont prescribe, dispense will drive demand for these medicines, hta and members agree with the president s recent Oakland Convention and the National Academy of addressing the drug abuse issues overdose problem requires the collaboration by the entire industries stakeholders. Hda innocents are committed to be part of the solution. We endorse a comprehensive set of policies to prevent opioid abuse including the clinical appropriate guidelines and recommendations to curb overprescribing and approving the use of technology and data sharing. For many years those rightly by dea were challenged by a lack of communication and information sharing by the dea which ive lived through with my tantrum at this association. Over the past 11 years dea repeatedly evolved its interpretation of suspicious order monitoring regulation either the regulation itself has not changed since 1973. Over the same type dea revised its use of a controlled substances act requiring manufactures and distributes intimate effective controls against the version of particular controlled substances. Let me be clear hta and our members are committed to working collaboratively with dea and have been to address this issue of Opioid Epidemic. Hth is that wish to undermine the deas Enforcement Authority or deprive it of any of its enforcement tools. Our members have worked to comply with the deas expectation to adjust to the challenges that accompany this epidemic. Companies have invested heavily in i. T. Systems to better reflect suspicious order and patterns and an expert teams tracking customer orders. Hta has also repeatedly asked da to clarify its expectations by publishing some guidelines or regulations to develop an effective systemwide strategy the entire supply chain must understand where the agency is cong from. Others agree gao as youve all mention found a lack of communication between dea and distribute pharmacy physician registrars with hampering efforts to combat the diversion problem. Even the deas acting administrator told this Committee Last year in his view the agency had been slow and opaque in communicating with registrants. Deas use of immediate suspension order also raise concerns as the background introduced in the pharmaceutical supply chain must have dea registration to land in these controlled substances. It dea once kurt volker registration the standard process is the order to show cause which gives a registrant full due process before replication. The iso is an alternative remedy and an extraordinary remedy. Iso email immediately stops the registrar from distributing any controlled substance medications before any due process hearing happens. To issue an iso did minister must find the registration presents an imminent danger to the Public Health or safety. Until 2016 the definition of imminent danger was left at the subjective determination of the dea reviewed case by case by a judge only after dea suspended the registrar. In some cases dea issued iso claim imminent danger of activities that registrant had already halted and fixed. A lack of guidance plus dea shipping expectations has generated great uncertainty to the supply chain. Community pharmacist described difficulty in obtaining controlled substances affecting their legitimate patients. In 2016 congress about the need for clari and as for it through congress defined imminent danger for the first time. Members of the congress negotiated the law transparently with doj and dea. Passed both chambers without dissent with bipartisan support reflecting legislation offered some common sense solutions. Recent mischaracterizations have called for repeal of the law. Critics are saying the law passed in april 2016 hindered deas enforcement efforts in 2012 and 2013. Simply repealing the law would unveil legitimate patients and reintroduce uncertainty. It dea remains fully empowered to the comedic action against registrar. It retains and uses wide range of additional tools youve heard about this morning which range negotiations, voluntary action to criminal charges and forfeiture. The law has had undefended consequences. They dea and doj should bring the suggested changes to the congress. We will gladly work with you and the administration to address and identify these concerns if need be. We are committed to being part of the solution to the crisis while opioids are small, small fraction of the medicines we do distribute every day, were committed to collaborate and develop solutions. I want to thank you all for this opportunity. Its been a Long Time Coming and thank you for letting me via. Thank you. Going to start with general frosh. 43 of attorneys general including yourself asking a letter asking for repeal of the law. That letter said the language quote effectively eviscerates the deas the ability to act, and you also said that in your testimony. This first question probably doesnt take a long answer. Its the second one i would like to have more, the first question, do you have any data to support what youre telling us . And if not, right now, would you be willing to provide that data . Thank you, mr. Chairman. Yes and no is the answer is do we have dated. You have put updated that i think shows how infrequently isos are used, and with all respect i think some of the comments were looking at it from the wrong end of the telescope. You see how few there are. I mean, even before the act you saw that they were in the Single Digits for i think it was 2011, perhaps there were 65 and dropped precipitously down to eight, five, nine, et cetera. What that shows you is that the isos used extremely infrequently. So to pass a law that makes more difficult to use one, when the actual numbers were in the low Single Digits doesnt really make sense. I think you have 40 year history of language that exists, that existed in the statute before last years act. Maybe you could give us some examples in your state of where the law has negatively impacted your investigation. We work closely with dea. We just did a major case with them two weeks ago. We have busted pill mills and doctors who are selling prescriptions out of their cars. We dont have the authority to stop distribution. All we can do is catch it on the backend, and so it hasnt impeded our office but its pretty clear i think from the article written by judge mulrooney and the cases that are brought that the law is at best unnecessary, and at worst harmful. Mr. Gray, my first question may appear to be confrontational not my second and third one. In advocating for change wasnt the industry trying to weaken deas Enforcement Authority so that your companies would not be shut down in the face of isos . [inaudible] that was not my take at the time all this happened. I lived through the process of the communication shutdown with dea when they changed hands in 2006, and i witness listening to our members and the groups that we put together to talk about this. Struggle mightily with determining various standards and algorithms for determining what is a special order, special suspicious order and what is a this went on for a number of years. Enforcement began happening. In one case as indicated in testimony the problem had already been fixed, yet the enforcement was done. The bottom line is, the reality in the minds of people to do with the, it appeared to our members the glenwood costofliving shifted and it was no steadystate by which a company would look at in order and say yeah, this is awfully suspicious, i should report. In fact, i can tell you anecdotally i met i can type one company i think you just answer my second question. Why wasnt the previous language sufficient to provide the companies clear guidance on how to operate effectively and lawfully . The guidance was merely to letters come to page and a half letters that called for the reporting of suspicious orders. There was no definition of work behind it. We then begin asking can you do some regulations around this so we have an idea with some of these terms in this led me for reporting these orders. We submitted over 40 questions three times to the agency, got an answer. So the bottom line is, wholesale distributors were on their own developing their own algorithmic system to determine some of my members had to do by hand, some have the resources to invest in computers and make it more effective and quick. The bottom line is they did this in the blind, and the consequence was at a time when this opioid problem was beginning to expand as ms. Chambers noted, a bit ability to these drugs became limited because our members, the old adage when a doubt cut it out, whe the dea would not answer, that is or is a suspicious order, of which is t off the pharmacies. This is my last question. Do you, can the distributes work effectively with the dea without limiting deas authority to make sure opioids dont fall into the wrong hands . Well, we try to make that in our daily delivery how the process moves we try to make sure that only gets to license dea pharmacies but. We dont ship to anything that doesnt have dea license. I hope that answers your question. Let me state it again. I dont think it does. Cant the distributors work effectively with the dea without limiting deas authority to make sure opioids dont false be absolutely. I think we can. I will tell you this. Since the change at dea, theres two deas, the dea between 20062017 and the dea today. I think our members would agree the working relationship is been dramatically improve it is a because of this law or the change, i dont know but there is definitely a more open communication line. I fed my own personal conversations. Without her own meetings. There is clarity. I will tell you as an example dea put on a wonderful meeting a year ago and the young judgment on the legal team came in and discussed the masters case if you make may may not know the details of that. Its not important but what he did is the outline for all the registrants can pharmacists, said look, here is this case. This is what were expecting on the appeal. If this happened to the south dea can use this case to enforce. That helped our members to understand where the lines were being drawn. That all happened in the last 24 months. It has improved and will continue to work with them. Senator feinstein. Thanks, mr. Chairman. Im from a medical family. My father was a general surgeon and my husband, passed away, a neurosurgeon. So im very much delay with the term do no harm. In my view, this bill has done harm, and i look at these figures and i look at the answers that we got from the dea. It seems to me that we should look very closely at repeal. My question, general, is how do you view the possibility that this could really be turned into something that could be workable . There is so much money to be made and so much that has been made that its very hard for me to see any amendments turning this around. Thank you, senator. I am not able to tell you what could be done to fix this. The positn thateaken, the one that my cagues, the 43 other attorneys general have taken is that it ought to be repealed. We think it does do harm. I think opioids are overprescribed, and taken too often in the United States. We are 4 of the worlds population. We consume 30 of the opiates, prescription opiates. We experienced 27 of the Overdose Deaths in the world. Thats an extraordinary relationship. We are punching 8. 5 times about our weight in terms of consumption and death. As everyone has noted, 14 billion pills per year for our country, it is way, way too many. And we have of course to will to make sure people are suffering horrible pain get the relief they need, but we are so far in the other direction that we need not just a course correction. I believe that last years act went in the wrong direction, taking us back to where we were before is at least a step forward. Thank you. Dr. Catizone, if the bill were repealed, what would the board of pharmacy do what actions would you take most likely . Senator, if the bill was repealed i think the states would continue to utilize the resources they have and probably provide for cases over to the dea, that theyve invested and found. Perhaps i can, just a little bit further. Please. Theres either something wrong with the data, something the facts of match. If we have a situation with the committee and dea are reporting the issuance of isos were minimal against wholesale distributors, four years prior to the enactment of the law, but the industry saying it was a device that was threatening or stopping shipment come something is not correct. Either isos were being issued or not, either the industry was being affected or not impacted by it. Any of the question, if you ship 9 million dosage units to one pharmacy, where are the safeguards if the dea is not able to stop that . Whats the responsibility . Thats what we think the law would need to be amended. Well, im looking at this chart of iso suspension orders from 200817, and in 2011 there were 65 and asked the question why andy was the pill mills. And then he began to drift down. In 2014 it drifted down to Single Digits,nd it has remained in Single Digits. So this, in view of what we know is out there, indicates to me that the agency isnt properly functioning. Because the suspension order should be way up. I dont know whether there is interference. I know there to be made. Interference from the pharmacy industry or anyone else, but it appears to me based on these figures that the law is not working. Do you agree with that, or do you find otherwise . We agree the laws are not working. Mr. Frosh . Absolutely they are networking, senator. We have so many, well, 200,000 deaths since 2000, the year 2000. 2 Million People Million People in our country addicted to opioids. They are clearly not working. Mr. Gray . Well, as far as the law, really since 20122013 that was the High Water Mark in the West Virginia situation is a good example. And that was a systemic failure from overprescribing. We lives Logistics Group with it and a whole system. The product, it is pulled by the prescriber, filled by the pharmacist and in the pharmacist orders to the wholesaler. The wholesaler only shifted dea licensed. All the way down to the manufacturer. There was a systemic failure of reporting. Our members based on the lawsuit in West Virginia did file suspicious reports. They filed all this data with dea, and yet there was no enforcement action. At the same time i know for a fact that our Companies Working overtime on these i. T. Systems to determine suspicious orders. What i would argue what happened since 2012 and 2013 because ive because i found it quite down, phone calls to quiet it down, its less and less concentration between dea agent i believe in my members because i think they are doing, my members are doing a better job now that they have self defined for each company do you really believe that with all of the pills that are out there . You a member still realize this is too many . No. Again, the dea sets that quota. The product comes into we only ship comes up every 50 50 statn the union orders this product, mathematically, its high that we ship. We are reporting are suspicious orders. And so there havent have been enforcement action and i visited meetings about issues but its not been, its not been followed on. You know, i think as far as my 35 companies its trending in the right direction. My time is up. Thank you very much. Senator hatch. Thank you, mr. Chairman. Madame cochairmen. I like to begin by thanking witness for appearing here today, a particular like to thank ms. Chambers who is a constituent of mine and i appreciate her coming. I think youre played an Important Role in bringing this issue to my attention. You have shown a lot of courage by being here today and i really appreciate it. Let me just ask mr. Frosh, id like to ask about the letter you and a number of other state attorneys general are calling for repeal of the bill. I found the literature is because making the case for repeal, the letter essentially relies exclusively on the article of the judge mulrooney. Sites no data or indeed anything other than judge mulrooneys article in describing the impact. Impact. My question is this. What independent analysis of the law to you and your colleagues conduct before deciding to send the letter . Evidently you judge judge mulrooneys article. Did you do anything else . Yes, senator. First let me say i found judge mulrooneys article to be a very powerful and persuasive, but there is no data since the law was passed we dont have that to work with. But each one of us, all 44 of us are attorneys, and we look at the law. And i know when you try to prove a case, when a standard changes, its significant and the changed year is an extraordinarily high standard. When you have to prove a substantial likelihood of an immediate threat of death, serious bodily harm or abuse of a controlled substance, its extraordinarily difficult. That is a very, very high standard. The need lawyer can tell you, it makes a big difference. So theres no Statistical Analysis that i i can give yout there is a legal analysis, and it is shared by 43 other ags, and were easily divided among republicans and democrats. Okay. Mr. Gray, the report i referenced earlier described clear guidance of vat distributors regarding what constitutes a suspicious order. And what can trigger an enforcement action. Will can you explain to the committee at the absence of clear guidance is impacting distributive practices and how the ensuring Patient Access act address that particular problem . I can and to if you just wao lead off by saying the following up with senator feinstein. I think the key to this law is like any of the law we need to get a time and find out if there are issues and concerns. After 18 months this law has not been really tested in the marketplace. I think time will tell and if its appropriate then well go back and demand if you have to. But as far as the process unfolded, right, our members struggled between 20072012, 2013 by numerous attempts at meetings. I went to one of them. That happened to be the last meeting in 2010 and we never met again with dea. We submitted written questions, very specific questions about suspicious oers, the nature of suspicious orders, things get into the location of pharmacies, are then your pain clinics, yr state boards and what have you. And we received, we submitted this questions three times that we still dont have any feedback from them. So our members as i said they went on, they had to go on their own initiative to try to define those lines. You indicated they stop supplying with no evidence. I cant speak to an individual Company Decisions but i do know many of them i spoke with wood, after their dea meetings, quite honestly terrified saying look, i think theyre going to for my license. We are not sure. This stuff is on the edge because of the problem is with our members submit to one pharmacy, a shipment of pills, we report that order whether its suspicion or not to the dea on a weekly basis. So the dea has that. But whats not told is the dea also has data regarding multiple other distributors because many pharmacies are served by more than one wholesale distributor. And so the dea has all the socalled arcos data. I asked dea for years, hand can the dea look at us as partners and try to share some blind dea data . Are full data so you can see the full picture of the pharmacy, so my wholesaler can look at and say my shipment is on the edge but if theres the other wholesaler also submitting, then its clearly in the realm of suspicious and we should cut them off. I have been, i asked about three times formally can we do this, can we get together at a competing answers that we cant blind the date and this and that and the other. I never have quite believed the legal argument they like to use but thats fine, but i sure wish arcos data is a powerful tool and it is something hasnt come up in the ceiling but arcos data sharing with wholesale distributor would help clear a lot of this problem. I have said for years if the dea sat down with my 35 members and constructively used arcos data i would believe within 24 months most of the bad players in this country could be ferreted out very, very quickly as opposed to the conjugate with them playing. Glad to have your testimony. With everything from former dea officials expressing concerns about the act and other aspects of deas interactions with registrants. From your perspective as communication with dea imprint in the last 18 months since the ensuring Patient Access act became law . It actually has. With the change of personnel i was able to open a line of communications with the head of the diversion control. With several conversations personally at some of our meetings. The dea has been developed for our comforts. They come and speak directly to our members, and instead of bringing the old slideshow which they showed tenures in a row we now have new information they are sharing with us which i think its a huge improving. Moreover, as indicated, another stakeholder meeting in the spring, we had one a you and have to go when the young attorney from the office came in to give his musings on the matthews case and what it would mean if the dea when that case. They dea won the case which is great but now my members at least have an idea what dea is think in terms of what the next legal boundary is. I think its 100 improved in the last 18 months, and yeah, i can be very complicated dea since then your it was not the case from 20062016. Thank you so much. Thanks, mr. Chair ear. [inaudible] thank you, mr. Chairman. Like to ask the committee and id like to on behalf of all of us on the committee thank those of you on the panel that testified today. The ongoing opioid addiction crisis is something that is on every Single Community come has affected every state. Just my small state of delawe lost more than 300 people who died from drug overdoses last year. What were trying to do a strike the right balance between making sure that people suffer who sum persistent and chronic pain like ms. Chambers can get access to a properly prescribed and manage opioids, and those who are abusing them or misusing them are abruptly held to account. So striking that balance is the purpose of her hearing today and i would appreciate if you pointed at you to some simple hopefully pointed questions. To attorney general frosch, delaware, under the leadership of our attorney general recently enacted new regulations that allow prescribers to better monitor each opioid prescription and limits an adult from receiving a firsttime prescription of for more than seven days here except under exceptional circumstances. That has led to a 12 decrease in the number of opioid prescriptions just since april 1. Shouldnt we be look at some of the positive innovative work that is being done in states like delaware . Yes, absolutely. A number of states have Prescription Drug monitoring programs. They can be asked what nearly effective they can be extraordinarily. Despite the fact loss of in enacted we still have this hideaway opioids washing across, and those are important steps forward but we have a lot of work that remains to be done. Help me, the deas use of immediate suspension orders has dropped but other enforcement tools like orders to show cause have increased. Are these other tools sufficient to combat the misuse or miss prescription opioids . I dont think they are. You only have to look at results to come to that conclusion. Dea has essentially had the same tools for four decades, and they have not been sufficient to overcome the wave of opioids that is washed across the country. So i would say not. The prescription that i would give is holistic, we not only need effective Law Enforcement interdiction of illegal and, illegal supply, but we also need treatment, Prescription Drug monitoring. We dont have nearly enough treatment thats in our country. We are not making forward progress. We are making progress but its incremental. It needs to be much more rapid. I agree with you. Dr. Catizone, what else can we do as a committee and as a society to address the significant problem of opioid addiction . The answer is the bouncer spoke about. We need to have bounced between access and effective Law Enforcement. To the prior question the committee presented even look at the data as an overview, the dea has taken action of the heirs to compensate for the inability or the intention of trying to take an iso. There has to be some balance there as well. Isos should be restricted to the most serious and egregious cases where patients are going to be killed. Those cases standard work. You saw by the date of the amount of time isos were use were very limited. We think restoring or eliminating that data, the new standard is a means that would quickly address the issue and give the dea that important back use that in very limited but very serious situations. Mr. Gray you represent distributors pictures been a lot of concerns expressed today on both sides about the ensuring Patient Access and effective Drug Enforcement act. How do you think we can fix it and how do you think we can improve and sustain the working relationship you just talked about with the dea to crack down on inappropriate prescribing behavior and to make sure that those are generally in pain like ms. Chambers are able to access the prescription opioids are they need . First, let me say that they dea i think disagree with us. There needs to be some definition of imminent danger. If its not the right one that we should fix it. As i said let time see how that works out. It may have been a rush to judgment i agree with some of the panel, probably not the best way to go, the most judicious way to do legislation but that being said, i personally believe we can talk about the mechanics of Law Enforcement and Pain Management but from a personal experience, and this just happened to me in the last 96 hours, i spent 24 hours in a Major Hospital here, this shoulder, ifad, i now understand pain. I never understood persistent pain. Since august 3 ifad pain every day in my body moving different places from my shoulder down to my arms and it has been miserable. Two surgeries, the most recent last thursday to fix this bone for the second time and then scope out the shoulder. And in the hospital in a 24 hour period, i was asked no less than five times this question as i sat down wherever i was going in, could you describe your level of pain . I look at these people and i said this isnt about the pain. Pain will take care of ielf. You need to give me a number. What is your pain . So i begin making up numbers. And then when they sent me out at the hospital after 24 hours with a prescription of oxycodone, we couldnt get it filled. My insurer wouldnt pay it. And so its like well, so i pay for it and i used about five of them and that it and im off it now because its not good stuff. But it did immediately after surgery, but you know, its a systemic problem beginning with the medical community if you ask me. Im not thinking of them but the bottom line is thursday, a pattern in the medical community that Pain Management heels, makes healing go faster. Let me ask my last question if i might. You concluded with what seemed an intriguing possibility that distributors and the dea could work more closely together to genuinely identify bad actors and to allow the continued delivery of needed pain medication to those who legitimately needed. I have firmly held, if the dea opened the door and said lets work with you as registrar, not as a criminal as we used to be defined i someone in that agency, we were called criminals, it we work as a registrar i actually believe between the resources and access of information that my numbers have and the Bigger Picture of information dea has, this shouldnt be a problem to identify the bad players. I appreciate your testimony, but as you represent those who struggle withain chronically and daily, those who are charged with Law Enforcement and protecting our constituents, hundreds of whom are dying, thousands across the country, and those who are pharmacists, professionally trained to dispense appropriate, we have to get this writer went to work it out and we need a sense of urgency about it because there are literally people dying and people suffering needlessly. Thank you, mr. Chairman. Senator hatch had one of the thing you to do. [inaudible] just wanted to thank you all for being here for your testimony and for your help to this committee. Its been great. This is a really important subject and we all concerned about it. So we have learned a lot here today. Thanks so much. Ms. Chambers, where you try to get our attention . Yes, sir. I have three quick points. The patients really want this law. We are so grateful that it has come about and you guys have to talk to each other. We want the dea and the distributors and the doctors and everybody to be talking so that they know what the problems are and that they had communication about what the exact definitions are of when the distributor is in violation of what theyre looking for. This hasnt happened in the past. We need this. Nationstate access to my second point is that prescription opioids are only a a part of te opioid issues. The opioid illegal opioid opiate epidemic in the United States. Theres a lot more thats going on besides at that. The third, i wish senator was just a because answer to his question is if we have the cart before the horse, if we took money and put into paying research, we would need so many opioids. Please, i hope every member of congress understands we dont have enough money. Its Something Like six cents per patients on paying research in america. Nih needs a Research Institute peer we need to pour money into different pain treatments. Patients dont care whether or not we opioids if we have another pain treatment. We just need pain relief especially severe pain. Right now thats all we have and we are begging for help. Thank you and thanks all of you for your preparation and or delivery in answering questions. Remember what i said to the first panel, you may get questions over the next week for answer inviting. So staff notify all members, can get your questions in soon. If you do we would appreciate your response. Thank you very much. Meeting adjourned. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] the second session of the 115th Congress Starts next week. The scent is back on january 3 and will welcome to new democratic lawmakers, Alabamas Doug Jones and minnesotas tina smith. The house of representatives returned a few days later on january 8 here in the new Year Congress needs to consider i i Government Spending bill because current government funding runs out on january 19. Also on the calendar this years state of union address, House Speaker paul ryan has invited President Trump to address a joint session of congress on january 30. When congress is back in session, the scent is life on cspan2 and the house is live on our companion network cspan. Cspan, which history unfolded daily. In 1979, cspan was created as a Public Service by americas cabletelevision companies and is brought to you today by your cable or satellite provider. Tonight on cspan, i debate on free speech on College Campuses with First Amendment scholars and authors from around the country. Our traditional liberal are divided now on this question mark free speech on campus. There are those liberals who basically see themselves as most committed to quality and what they see as justice. And feel that should override the liberal tradition of defense of free speech get on the other edge of liberals who see the tradition of free speech and the commitment to free speech as almost existential importance given our history and the ways in which free speech has been restricted historically by people and traditions of power and do not trust anyone including themselves to the power to decide what points of view can be a spouse and not espouse. On the conservative side, and almost every episode in american history, efforts of suppression of speech have been driven largely by legal observers whether its in the early come in the academic realm, whether its in the early 19th century where its about religious moralism of whether it was opposition to darwinism or whether it was the turn of the 20th century with punishing faculty members and students who criticize wealthy donors or world war i or anyone criticize the war or the draft could be thrown out or during the mccarthy era, for example. Its always been conservatives who have been on the side of restricting free speech. Even on the larger National Community with the exception of Campaign Finance and commercial speech, for the most part its been conservatives who have been much more restrictive. I find it a bit annoying to be honest that all these republican legislators are suddenly championing free speech in a situation in which the people who are being silenced our Milo Yiannopoulos and ann coulter and what is with back about them compass , is that the principle of free speech as it is a particular that bothers me. Its a matter of principle in terms of what this is all about. You can see this entire discussion from the National Constitution center, the Federalist Society and the American Constitution Society tonight on our companion network cspan at 8 p. M. Eastern. Cspan cities tour takes you to springfield, missouri, on january 6 and 7th. While the springfield were working with media, to explore the literary scene and history of the birthplace of route 66 in southwestern missouri. On saturday january 6 at noon eastern on booktv, the conflict occurring along the kansasmissouri border and the struggle over slavery in his book the border between them. In 1858 john brown havent left kansas comes back to the territory and he begins a series of raids into western missouri during which his men will liberate enslaved people from missouri and help them escape to freedom. Who or he did when left off last was organized then go on a very large hunting safari in africa. This particular life was prepared specifically for the president ial seal engraved on the breach and of course roosevelt was famous for the Bull Moose Party and there is a bull moose engraved on the side plate of the sky. This guy. Spinning now, youre not Education System programs for military veterans. The House Veterans Affairs subcommittee and Economic Opportunity heard from officials with the Va Education Service and the Vice President of the group that represents student veterans