Transcripts For CSPAN2 Prescription Drugs Law Enforcement And The Opioid Epidemic 20171222

[inaudible conversation] welcome everybody. Thank you for your attendance, particularly those who have to testify and answer questions for us. 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 had a long name. But for maturing Patient Access and it took the Drug Enforcement act. Somebodys going to have a pronunciation for that acronym but im not going to. Im going to refer to it as the law or the bill. And im eager to hear from all of our witnesses today. Some would like to see this law repealed.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 im interested in hearing both sides of the argument. This discussion is particularly important given the continuing Opioid Epidemic. That has ravaged this country through the past several years. I do have concerns with how we got where we are today. The discussions that weare having today. When Congress Took this still up in 2015 and 2016 , there was little to no fanfare about the proposal. The basic goal 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 or called iso. And this industry and iso, it can be a death sentence. From their standpoint, clarifications seem not only fair but a necessary step in helping figure out how to comply with the law. Another practical concern, that of ordinary people with legitimate needs having access or losing access to essential prescriptions with legitimate distributors were shut down. Dea understandably had some concerns about hurting their enforcement powers. Beyond limited undefined Enforcement Authority needed some defiance. Dea also had litigation risks with such undefined authority. So dea to have an interest in working towards amending the language that would produce its 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 for the house of 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 agree to the language in the final bill. We discharged the bill from committee and 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. The dea testified that they advised president obama to do just that. So let me be clear. The dea or department of justice didnt want this bill. I wouldnt have taken it up. Then the Washington Post and 60 minutes ran pieces criticizing the new law. The stories highlighted former dea employees and quoted a law review article from the acting chief Administrative Law judge, of the dea. The reports from media suggests 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 described, its fair to everybody to see, fairly clear to everybody to see that nothing could be further from the truth. Ive 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 office to do just that. Its the type of work we doing this committee and we did it to provide more effective ways for Law Enforcement to do their job in the Drug Enforcement area. Im especially frustrated by the dea itself who Gave Congress the goahead to enact this legislation. We wouldnt be here today if the dea told us that they objected to news reports also suggesting that the law effectively strips dea of its enforcement power. The data appears to show otherwise. Prior in other words, the datashows that prior to the passage of the bill , the between years 2011 and 2015, the amount of immediate suspension orders dramatically decreased since the law was passed. The amount of immediate suspension orders has increased. Moreover, the number of opiate distributed overall has increased between 2016 and 2017 which all comes after passage of the bill. The da has said the law did not stop dea from doing its job in the divergent 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 we are here and i am looking forward to hearing what those are. In other words, what the criticisms of the law are. We shouldnt be repeating laws just because the law is first in the room and solely based on one persons sayso. The dea agent who was the centerpiece of the news article is a consultant for trial lawyers. So is 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 in this country. It is vital that our federal laws keep up the best way to combat illegal opioid use. Before we start, i have a prepared statement from congressman tom marino, author of this legislation and an original cosponsor of the bill and he introduced the house version. I have a statement from congressman tom marino that im going to enter into the record without objection. Ms. Feinstein. Thank you very much mister chairman. Im very disappointed that neither the dea nor the Justice Department would allow dea Administrative Law judge maloney, 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 12 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 that we have other people and they will not make it available. Its the 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 us before the committee. Today we are confronted with three indisputable facts. One, we are in the midst of an Opioid Epidemic the likes of which this country has never seen. Two, we have a collective responsibility to better address it. And three, clearly, Law Enforcement cant keep up. 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. Outlines the conditions that must be met by drug manufacturers and distributors in order to obtain a dea registration. Two, it defines what is quotes, imminentdanger to the Public Health or safety. And in doing so, it lays out the circumstances under which dea 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 of when dea might take action against them. This point was underscored in the 2015 gao report which made three recommendations to the ea about how to improve communication with registrants in order to ensure better compliance with this law. Dea is not yet implemented these recommendations. At my understanding. Third, the law allows registries to submit a corrective action plan prior to dea revoking or suspending the registrations. However, it also relates that when an imminent danger exists, dea may immediately suspend a registration even if the registrants submits a correction action plan. Finally, the law required by health and human services, the 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 hindered its enforcement efforts. To the contrary, it shows that dea Enforcement Actions what will now starting to increase our declining well before this law was affected. Or enacted. Between 2011 and 2016, immediate suspension orders filed against pharmacies went from 21 to four and those filed against practitioners went from 43 25. 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 levied against a distributors dropped from 3. 1 million to a mere hundred 15,000. Sounds to me like something isnt working. So during the same years we saw opioids Overdose Deaths increased by 57 percent. Deas Enforcement Actions in many categories substantially declined. What i want to know is why. Something isnt working. It needs to be fixed. If its not the law and i asked dea and the Justice Department for their assistance in looking at the law, then we need to figure out where the problem lies. Ive been struck by the examples of negligent distributor raised in recent hearings and roundtables. Let me give you an example. In a twoyear period, nearly 9 million opioids were delivered to a single pharmacy and West Virginia. 9 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 the state. The result a reported 17 billion profit to distribution companies. And heres the price. 1728 fatal overdoses over six years. 1728 80 overdoses versus a 17 billion profit distributor. Consequently, many distributors faith and settled lawsuits with the state, yet almost all of them maintained the prescribers, pharmacies and Law Enforcement are better situated than they are to prevent version. Its hard to imagine a circumstance under which a request for 9 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 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 the dea needs to issue more guidance as to what can constitute a suspicious order. But these examples illustrate the fact that some distributors appeared to be more concerned with their bottom line then 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 cannot continue, ladies and gentlemen to lose more than 33,000 americans each year to an epidemic thats entirely preventable. Thank you mister chairman i want to associate myself with the disappointment that senator feinstein expressed with the witness we asked to, was denied coming by the administration. And today we sent a letter to ask reasons why because we didnt get proper justification. And of course now writing that letter doesnt do any good except to give us justifiable reason if they have one and i doubt if they do. But if its okay with my colleagues i want to call on editor hat before i introduce our witness and his leadership on this issue. Senator hatch . Thank you sharon for allowing me to make a statement. Profit in this town, the narrative gets ahead of facts. This paper paints an explosive painting and its often racist, it doesnt often matter what the actual facts are. It starts rolling and Everyone Wants on or off as the case may be. I was most surprised and disappointed by how quickly everyone seemed to start running from this bill the moment some negative news report came out. From senator mccaskill to senator mansion to attorney general sessions, everyones trying 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 entered a 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 passable set by unanimous consent. So these last two months have been frustrating to me mister chairman and 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 and of my involvement in this committees involvement in the facts of the laws impact. Lets start with the impetus for this law. This law came about not because i or anyone else got some giant check but because of real concerns the way bea was operating was threatening Patient Access. Representative marino has 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. I heard similar concerns from constituents, one of them will be testifying today and it wasnt just opinion. The pharmacies were facing supplychain problems. January 2014 survey by the National Community association of pharmacists found 75 percent of respondents have experienced three or more problems to stop shipments in the previous 18 months and the majority had to turn patients away as a result. This course from indiana to florida detailed stories of legitimate patients having significant difficulty obtaining needed medication. No doubt the supply chain causes but deas activities were a contributing factor. According to a 2015 gao reports, the lack of forgone student distributors on what constitutes a suspicious order what can trevor and enforcement action was waiting may distributor to place quotas on drug shipments to pharmacies and practice the report found cant met negatively impact patients access. The report detailed how Enforcement Actions coupled with the lack of Agency Guidance was leading distributors to decline the pill orders even in cases where distributor had no evidence that a pharmacy or doctor was engaging in divergent and it wasnt just my hindsight, i had individual tell me the deas attitude toward registrants during this period was downright intending to stick. I have a letter from the professor that describes some really troubling conduct by divergent control agents and that explains how difficult they found it to try to work with the agency in good faith and it wasnt just the private sector that was having difficulty dealing with the dea. In a separate 2015 report about drug shortages, gao described the great difficulty it had in getting information from deas office of divergent control. According to the report, the gaos work quote, was delayed significantly because of deas refusal to comply with gaos request for information for over a year. Only after the intervention of senior doj management officials was gao able to obtain the data it was seeking. Ensuring Patient Access and effective Drug Enforcement acts in an effort to respond to these problems. Provides clearer guidance for supplychain members and to encourage greater cooperation between dea and the requested community. Thats why define the agencys suspension order, thats why it provided for corrective action plans this wasnt some effort to help drug companies. Give me a break. This was an effort to ensure that the eos praiseworthy efforts to stem abuse dont end up earning legitimate patients. And i like to say a word about how this law came together. I want to declare the outset this was not a farm bill. Dont tell me i did this because the farms donated however much money to me. Senator whitehouse and i negotiated with dea distributors. And after introduction, i thougt 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, and so i had to accommodate some requests from industry stakeholders at the request of other members of this committee. I negotiated these changes with dea and doj. In fact, the department of justice gave me the substantial likelihood language that critics now seem so fixated on. And once dea and i came to a point where we agreed on a path forward, i asked the chairman to put the bill on a markup. And 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 id promised dea i would make. I did all of this in good faith. I later came to find out that, 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 rye to stop the bill 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. So thats how we got here. The bill addressed a very real problem, and it did so in a carefullycrafted, care anynegotiated way carefullynegotiated way. If dea has concerns with the bill, im happy to hear them. But id also ask them to explain why those concerns did not cause it to stop the bill 18 months ago before it became law. So with that, i thank you for allowing me to make these comments, mr. Chairman. Mr. Chairman . Senator whitehouse. I will only speak briefly. I accept and adopt the remarks of senator hatch. The only thing that 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 responsibilitying for that backstop to a separate agency then, 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 its fine to go ahead without it given that they have delayed, but this would be a 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, ms. Ashley, and then ill swear her, and then well listen to her testimony, and then well have questions of her. She represents the u. S. Drug enforcement administration. Ms. Ashley is currently the acting assistant administrator for the Diversion Control Division of that agency and has worked within that agency for now over 30 years. As acting assistant administrator for dea, ms. Ashley oversees investigations, influences regulations and advises National Security staff, government agencies, media and private organizations on matters related to the diversion 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 . Thank you for your ascent. Now you may proceed with your testimony. And as usual, if you have a much longer testimony, itll be placed in the record. And i never rap the gavel at five minutes, but try to sum up as soon as you can after that time happens. The red button. [laughter] chairman grassley, Ranking Member feinstein and distinguished members of the committee, thank you for the opportunity to discuss the Drug Enforcement act. This legislation altered the procedures that government, the manner in which dea seeks to revoke registration against those who continue, 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 opiaterelated deaths. The epidemic has created a generation of abusers. Currently estimated at 12 million. While prescriptions for schedule ii opioids have begun to decline, making schedule ii opiates less accessible, mexican drug cartels have filled the void by producing cheap heroin and counterfeit pills often mixed with fentanyl. The results are tragic. With a record 64,000 Overdose Deaths in 2016. I want to assure this committee that dea uses all tools; administrative, civil and criminal to insure its 1. 7 million registrants comply with the law. Since 2011dea has revoked nearly 1,000 registrations each year through orders to show cause, immediate suspension orders and voluntary surrenders. Isos are used judiciously and have historically been used against those directly responsible for causing harm in the community. Doctors writing illegitimate prescriptions and pharmacies that fill those prescriptions. As someone with 30 Years Experience as a diversion investigator and now as head of the deas Diversion Control Division can, i have used all of 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 insure compliance with the csa. Over the last decade, dea has levered nearly 390 million in fines against opioid distributers. And entered into memorandums of agreement with each distributer that establish additional compliance measures to insure that they report suspicious orders. The same distributers 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 its criminal investigators by embedding them 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, and to our present total of 77. Last week we announced the results of operation faux pharmacy. This ongoing effort targeted 26 pharmacies in california, nevada and hawaii. To date, this ongoing effort has resulted in 23 arrests, 4. 3 million in cash, and perhaps most importantly for purposes of this hearing, ten voluntary surrenders of pharmacy registrations. We are also scheduled to increase the number of tactical diversion squads to 100 by 2019. The Diversion Control Division also works closely with registrant community to educate them of their regulatory requirements under the controlled substances act. We currently completed we recently completed a nationwide Training Initiative to raise awareness on the importance of the role that pardon me cysts play pharmacists play in filling valid prescriptions. We offered this training free of charge in all 50 states, the District Of Columbia and puerto rico and trained 13,300 pharmacies and pharmacy technicians. I am happy to announce that in 2018 we will begin a Similar Initiative to train doctors on recordkeeping and other regulatory requirements. Many of our colleagues have asked how has 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 noncompliant manufacturers and and distributers. This law has changed the manner in which dea pursues orders to show cause against registrant. The law now gives the registrant an opportunity to submit a corrective action plan. A very small percentage of registrants who have been subject of an order the show cause proceeding have submitted a corrective action plan, and none have been approved. Regardless of the Legal Framework in which we operate, dea will continue to work tirelessly to combat this devastating opioid with epidemic. If congress decides to revisit this issue, then 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 epidemic, and i look forward to your questions. Thank you, ms. Ashley. Well have five rounds of questions. Im not going to leading into my first question, im not going to repeat a lot of stuff i made in my opening statement, but it kind of adds up to the fact that when this law was passed, it was not controversial. So my first question is, my understanding is that dea is in favor of, quoteunquote, 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 . It seems to me a Pretty Simple question. Do you favor repealing 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, 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 Technical Assistance to the members of congress who drafted the bill . Talking about the bill thats 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 you know, 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 of how its made it harder, and thats, you know, since its enactment because thats when i came on board, since its enactment. Thank you. Youll see we have a chart up here. Both senator feinstein and senator hatch have 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 that a isos that isos went down dramatically each between 31 and 15 11 and 15. In 2011, dea initiated 65 isos, and by 2015 the number was down the 5. And this all happened prior to the enactment of this legislation. My question, couple questions, doesnt this data pretty clearly show that this particular bill had no effect on deas enforcement ability . And would you say many answering that question in answering that question that the data directly contradicts the claim that, quote, congress effectively stripped the dea of its most potent weapon by enacting the legislation, end of quote . And that the law made it, quote, virtually impossible for dea to freeze suspicious narcotic 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 those, so if an order to show cause is warranted at the time and thats not the direction that we go in, so i dont want to conflate the two that the number of isos went down. It could have increased in another area. It could have increased we have several tools in our toolbox. When dea engages with a registrant, we have the responsibility to detect and prevent diversion, and we have, also have the responsibility to insure that medicine gets where its 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, not necessarily wanting to conflate the two because isos or im sorry, order to show causes may have gone down, but it may have gone up in another area. Without agreeing or disagreeing with your decision not to conflate, it seems to me that when someone else from dea testified in the 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 . And he also testified at the same hearing, at that same hearing that this data did not show that the law fueled the Opioid Epidemic, and isnt that right . Because thats coming from somebody in your department. In our department. And i agree whole heartedly that it does not stop us from doing our job. We find a way because, you know, again as this committee, the speakers have already stated, this is a prescription or this is an opiate epidemic, and we use every tool within our boundaries that we are authorized to use to combat this problem. How, and thisll be my last question, and i have to go to senator fine stipe. How exactly feinstein. How exactly has the dea had to change its iso procedures after the bill was enacted . Senator, 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. And ill give you the example, even the one that was brought up a little earlier, a distributer shipping millions of dosage units of pills to a pharmacy in West Virginia. That pharmacy is responsible by law and regulation to report suspicious orders to the dea. They are responsible to exercise Due Diligence to determine, make a determination whether or not the controlled substances that they are handling, that they are accountable more it and to make sure that, basically, try and prevent any diversion. So prior to the law, if there were distributers who would do these types of things, send those millions of dosage units to a pharmacy, not report suspicious orders, we have found in particular cases internal documentation that would state basically giving guidelines on how to circumvent dea regulations. So prior to the law, that was enough ground for an order to show cause. Now, now that the haw has passed the law has passed, it states there has to be a substantial likelihood of an issue, and it has to be immediate, and it has to show abuse. So if i could give you this example p real quickly, im looking at my time here, if i could give you an example of a distributer, of a patient who has died. So we have death now. Going and getting a prescription from a pharmacy, the pharmacy and the patient pills the prescription at the pharmacy, sells that medication and someone dies. With the law thats in place now, i need to make a connection, a nexus between that distributer and a death versus prior to the legislation i can do it on the prevention, on the prevention level. This is before the bill gets i can start an immediate suspension order on the distributer 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. Okay. Senator feinstein and then im going to step out for a minute, and after her times up, senator hatch. If i dont get back. But i think ill be back. Thanks, mr. Chairman. I am looking at the dea immediate suspension orders from 2008 to 17. And in 2011, they were 65. In 2016 2017, there were 6. In 2015 where i pointed out 33,000 people died of overdoses, there were 5. I look at the aggregate production quotas, and there are four criterion. 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. Ill go back to investigators going where the evidence takes us. If an immediate suspension order is warranted, then thats where we pursue the investigation. And its in speaking to the quotas difference is im sorry, senator, your question in the beginning regarding the quotas. Well, the quotas dont include trends of abuse or overdose death rates or specific classes of drugs. Why not . I recall. So thats something we have to be very careful about. As i mentioned, we want to the prevent and protect diversion, and we have to insure an adequate supply. So as far as in making the determination of the trends, we are bound by statute when we make, when we determine what the aggregate quotas 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 have a more lengthier discussion how that type of thing can be added into, you know, 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 and nothing changes . If i can and 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, if i could respond to that. Again, we are bound by statute when it comes to quota. But there is something that that we can do 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 . A small pharmacy . 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. But i hear you, senator, and i understand, and id very much like to take that back and continue to work with your committee so in other words, presently a small pharmacy can receive millions of pills, and nothing happens. Thats not the way it should work, senator well, its working that way. You just said that that was the way it works. Senator, what a distributer is responsible to do is exercise Due Diligence. They are responsible to have great care and accountability over the shipments that they send out, and thats where dea comes in with the oversight and the regulatory controls. Well, when 33,000 people die in a year from overdoses, maybe a few distributers should be shut down. Hear you, senator. Thats exactly the way i feel. I hear you, senator. And i think this whole view of business as usual is just not working. So the administration really becomes liable for not making the changes that are necessary to prevent these Overdose Deaths from happening. And ive never said this before. Ive been on this committee for a long time, but i have never seen a more lax operation, and i just, i cant help but say that. And when people die because of it, i get really angry. Thank you. You bet. Senator hatch. [inaudible] before i begin, id like to ask if we can do a second round of questions with this witness after everyone else has had their opportunity to go. We, i think we will have time for that. Okay. Ill 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. And id like to start, ms. Ashley, by talking about immediate suspension of orders, or isos. There have been a lot of allegations of the insuring Patient Access act gutted deas ability to issue isos and caused Enforcement Actions to plummet. So lets look at the actual data. I have a chart here, right here, of isos issued by the dea over the last ten years. This data comes from dea. Ive given you a copy to refer to, and youll see that isos start off in low double digits in 2008, peak in 2011, decline until around 2014 and then stabilize thereafter. The vertical dotted line represents when the insured, insuring Patient Access act was passed. And, ms. Ashley, when you look at this chart that shows that the decline in isos began four years before the insuring Patient Access act passed, is there any conceivable way that the act could have caused a decline in isos . Senator, this is a tool the dea has historically used sparingly. Again, we move forward with where the evidence takes us. Now, theyve been used sparingly, but theyve also been used for the most part predominantly for physicians and also for pharmacies. Its a difficult challenge to connect a distributer and immediate yeah, but i was asking for a yes or no answer. Has it changed . Has impacted our ability to do isos . No, sir, it has not. In fact, youll note that dea issued more isos in 2017, the year before the act passed, than it did in 2015. The year before it passed. Id also direct your attention to the short orange bars on the chart. These represent isos against distributers and manufacturers. The blue bars are total isos, and the orange bars are isos against distributers and manufacturers. Isos against distributers and manufacturers have been a particular focus of news reports criticizing the bill. Now, these reports have describe thed these isos as deas most effective tool against large drug companies. Now, ms. Ashley, looking at the chart when the insuring Patient Access act passed many april 2016 in april 2016, how many yeareds had it been since dea had issued an iso to against a distributer or manufacturer . The last one was 2012, sir. Im sorry, i didnt want hear you. The last i didnt hear you. The last one was 2012, sir. Okay. In fact, it had been just under three and a half years, as i see it. So not only could this law not possibly have caused a decline in iso tos, but at the same time the law passed, it had been over three years since dea had issued an iso against a distributer or manufacturer. Simply put, the notion that isos against distributers and manufacturers were a critical and frequentlyused 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 . Its i do the agree, sir. But okay. Thats all i in fact, over the last decade the most isos against distributers or manufacturers that dea ever issued in a single year was three. Now, theres 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 mulroney, in fact, used some strangely intemperate language in his article in describing this position saying it was akin to allowing bank robbers to round up and return inkstained money and agree not to rob any more banks. Now, i have to say thats a bit much. The purpose of this provision was to encourage greater cooperation between dea and supply chain members. It was also to avoid the situation some doctors and pharmacists were facing 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 dea had alleged. Even if the doctor or pharmacy had not committed all of the alleged conduct. And just, and just to clarify, the corrective action plan provision applies only to showcause orders. Theres no rumor in the act that dea 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. Now, i do have another chart. I guess ill have to wait until i yeah, id like to continue with senator leahy. Thank you, mr. Chairman. This is, it is troubling. Obviously, dea or someone totally dropped the ball in West Virginia. Depths occurred 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 for medicinal purposes. And while the legislation were talking about passed the house and senate, nobody at dea opposed it and asked. So the whole thing is so murky, it seems the people selling, the pharmaceuticals the people selling the pharmaceuticals are about the only ones who are coming out well in all of this. Now, les been a lot of theres been a lot of discussion regarding deas use of immediate suspension orders, but isos dont capture all of the story. During that same period when they went from 65 in 2011 to 10 in 2010, i understand there were a number of voluntary surrenders, as many as a thousand a year, is that correct . Yes, sir. And could not a voluntary surrender be a quiet resolution to any serious criminal investigation . It is a resolution, and its a great tool for us, sir. But it also for the persons to avoid having to face any criminal charges, is that correct . So with the order to show cause and the iso, there would not be criminal charges, sir, but there is administrative action that would immediately stop the registrants ability to handle controlled substances. So it is a great tool for us. Well, but they dont have any penalty or public admonishment. Somebody else can just step in and start doing the exact same thing, is that correct . Well, yes, sir, that is i, as a former prosecutor, i tend to think of sometimes criminal action as being a deterrent, and if you have a thousand of these with noncriminal actions a year, is that really working much as a deterrent in your estimation . It is a deterrent, sir, because one thing we have to keep in mind is we have 1. 7 million dea registrants, and the overwhelming majority are doing things the right way. So theres that very small percentage that may be violaters, bad actors of the controlled substances act, and they are, you know, a tightknit community as most professionals are when theyre in the same business activity, and, yeah, i believe in my experience it does create a detenter effect. Deterrent effect. Theyre supposed to have, if theyre registered with dea, theyre subject to unannounced regulatory investigations every who every two years. And have these been effective . Has anybody evaluated these investigations . Yes, sir. And over right now, actually, we have a working committee to basically revamp our scheduled investigations. For the different business activities, there are different types of different periods of time when investigators would go on site and conduct those investigations. The reason i ask this, weve asked questions, for example, senator wyden and i sent a letter to doj and dea regarding diversion enforcement. This was in 2016. Especially after thered been an article in the Washington Post saying there was a coziness in the dea diversion Enforcement Actions because of coziness with the wholesale drug distributers. We finally get a response, it didnt answer the questions. Would you look at that 2016 letter and respond to us . Yes, sir. I okay. You said that dea is working to provide specific guidance to registrants regarding the identification and reporting of suspicious orders. That was a year ago. When will we see that guidance . Sir, were in the final stagesover that, and i anticipate itll be spring. And, actually, in the spring we also have a meeting with stakeholder registrants to have a discussion about it. In that are you being affected at all by President Trump saying if youre going to have a regulation are, youve got to get rid of two former regulations . Certainly we have to be in compliance with, with, you know, with the acts that are in place, certainly we have to be in compliance with that. So but that doesnt prevent us from continuing to draft regulations. Okay, thank you. Mr. Chairman, i think under those circumstances if i was going to be involved in criminal activity, i would love that order of one step forward, two steps back. But i thank you for your commitment to finally getting us an answer to that letter, and ill look forward to it. Absolutely, sir. Thank you, mr. Chairman. Ms. Ashley, welcome. How long have you been with dea . Over 30 years, sir. Okay. And youre the acting assistant commissioner administrator. Yes, sir. Does that mean youre the number two . No, id say im three down well, youre within the top five, huh . Top nine . Top five . Top nine, sir. Top nine, okay. What was your position under president obama . For a period of time, i was the Deputy Assistant administrator, and appreciate that i was Diversion Program manager in the chicago field division. So you were a senior official . Yes, sir. What was your opinion at the time about the insuring Patient Access and effective Drug Enforcement act . So if i can clarify, sir, i reported under, basically under the end of president Obamas Administration in october of 2015, so is by the time i reported, all those conversations had already passed, and it was down the road. I appreciate that clarification. You were aware of this this act . Yes, sir. When it was a bill . Yes, sir. Were you for it or against it . I was concerned about it, sir. And to whom did you express those concerns . It was internally to my staff. Okay. Did you express your concerns to anybody senior . At the time, it would have been my immediate boss who is no longer with dea. Uhhuh. Did you tell your immediate boss you had concerns about it . Yes, sir. But at the time, if i could explain, we had all just reported. It was just a new sweep in management, so he was at, you know, had just gotten familiar with the bill too. So he was not part of those conversations. Okay. Among the top ten people at that time when this act was a bill, among the top ten people at dea, who opposed this bill . Sir, i could name names, but none of those individuals are currently at dea. Okay. Name names. The prior Deputy Assistant administrator, mr. Joseph remember siz city he opposed it or was for it . He opposed it. Okay. 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 of when they were sitting in that chair, but there was a time where he had a Deputy Assistant administrator, his name was alan santos at the time. Okay, who else . The administrator at the time would have been michelle lynnhart. Uhhuh. Who else to opposed it . Thats all i can think of now, sir. When you think of others, could you write me this. Sure, sir. All right. Who among the top ten managers at dea at the time, who supported it . I wasnt present, so itd be difficult for me to say who who did you hear . I didnt have a conversation with anyone that told me they supported the bill. Okay. So nobody did. And you were a sir, 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. What im saying is i wouldnt know that. I had conversations with those who well, who would know that . Im trying to think of someone who is currently at dea that would have been part of those conversations. Current hi our acting administrator currently, our acting administrator was not part of those conversations, myself and my direct i directly report to the Principal Deputy administrator, he was not part of those conversations. I you said and i i understand and i appreciate it but, you know, were limited on time tell me who at dea pushed this bill. At the time. Sir, i dont have a name for you. But i would like to get back with you be i can make those determinations. Id like to do that. Well, see heres what it looks like to me, ms. Ashley, and i know senator hatch and senator whitehouse, and i dont believe that for a second that they would support legislation over deas objection that would hurt people. I dont believe they would do that. I think, i think dea or somebody at dea 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 posed to it so to opposed to it at dea, why werent they raising all manner of hell . [inaudible] saying to you that when he has a chance to think about answering your question, shell answer it in writing for you. You want me to shut up now, mr. Chairman . I was on a roll. [laughter] well, were going to have a second round. Ill take that as a yes and apologize for going over. Thanks, ms. Ashley. Senator durbin. Thanks for being here. It came as shock to me when there was testimony a couple of years ago by acting director of the senator kennedy, i learned something i didnt know, and 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 even year. 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 have 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 hydrocodone and oxycodone, they needed the permission and authority of the agency that you work for. The Drug Enforcement administration came to us and testified about the terrible Opioid Crisis, and then when i pipped them on it, it pinned them on it, they were giving the green light for the production of the opioid pills. And pharma, pharma in general, was asking for more and more and more and more. And i said to the head of dea, i think youre part of the problem. He said, yes, we are part of the problem. So what were talking about here is a unique situation where the Drug Enforcement administration is telling america how to get drugs out of america in one office, and in another office is giving permission for pharma to make more drugs. Currently, we produce 14 billion billion opioid pills a year. Enough for every adult many 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 to get it. But a one month prescription for every one of us in this room and every adult in america in come on. As they say in one of those sports shows. And you also i think what brings us 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 with a population of 392 people received 9 million hydrocodone pills over two years. Population 392, 9 million pills. Whos the cop on 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 a couple of times, i couldnt agree with senator kennedy more, i dont believe for one second when it comes to my colleagues or any one of us when voting for this felt we were making it easier for people to distribute an indefensible number of these drugs, but it happened. And i guess the question were basically canning you is now asking you is should we repeal the insuring Patient Access and effective Drug Enforcement act to make sure that 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 suspensions order is just one of them. We have not been hamstringed in a manner that we cannot continue to do our jobs. We look forward to working with this committee if the committee decides that there should be something differently done with the current legislation, but well continue to work within those bounds. So let me see here. The dea issued suspension orders 65 in the year 2011, and this was in the earliest stages of our Opioid Crisis, 5 in 2015, 9 in 2016. I think the cops on beat are not spending time looking more criminals here. If we are truly dealing with an Opioid Epidemic with numbers 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 2,000 last year in my home state of illinois, and then tell me that 9 suspension orders in the year 2016 shows that you have all the tools 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. And 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 tooled to do our job. Tools to do our job. And we have, you know, a dedicated work force as im sure, ive met with you a couple of times and had that discussion about quota. Yes, it did rise over several years under, you know, prior management at time. There was the deputy administrator, and as quota is determined by the, by our 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 also with our previous administrator, chuck rosenberg. We went back to the table, we had discussions, and we have lowered it. The first year ill just close, mr. Chairman. Were not dealing with a runaway virus here. Were not dealing with ebola. Were dealing with decisions made by people working in your agency and others in terms of the volume of production in america that has led to this epidemic and the abuse of that production in distribution by doctors and pharmacies and others and our failure to respond adequately. Thats why were sitting here today. Senator cruz. Thank you, mr. Chairman. Ms. Ashley, thank you for being here and testifying. I want to follow up on some of questions that senator kennedy asked you, and just youre here testifying on behalf of dea. Did the dea 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 agency. Yes, sir. So presumably, minute at the dea somebody at the dea knows whether the dea took a position on this piece of legislation. Yes, sir. The agency as a whole has a collective memory. If you werent involved in that, fine, but 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 initially working with the house and also with the senates judiciary committees. Did the department of justice express a position on this legislation . I believe that, yes, sir. Did they support this legislation . In the end, they support the ultimate language. I believe concern of how the bill would affect how we conduct our investigations 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 dea supported the legislation in the version that actually passed. Yes, sir. What advice did the dea 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 doj and the entire u. S. Executive branch was supporting the legislation. Set that aside. Were here now, were a year into it. Is it working or are there unintended consequences . We were able to continue to issue isos, as we have in the past, so it didnt hamstring us from are doing that. The concern was manufacturers and distributers, the ability to use it, and we have not executed one since enactment of the legislation, so that remains to be seen proving that case under the you havent executed one. Is that a problem . Is that a lack of Legal Authority . Why havent you . What are we missing . Actually, sir, the distributers and manufacturers that we were looking at that were doing the most shipment of drugs had recent, they had recent actions taken against them. And the other distributers, they, you know, theyre close enough knit community, a deterrent effect kicks in for but the larger distributers, 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, there hasnt been a factual predicate, there hasnt been a need for it, is that correct . There hasnt been a test case. No. What is not working about this legislation, if anything . This congress is trying to understand if legislation was enacted that made things worse, we would like to know that. But yall 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 distributer from making shipments before there is harm done so we could identify violations of controlled substance act solely that the distributer committed. The current legislation requires that we establish a substantial likelihood of immediate death, bodily harm and abuse. Prior to that we would only need to establish the potential, the increased potential for diversion. Does the dea believe this legislation needs to change . Dea, along with the department of justice, supports a change in the legislation, yes. What change does the dea support . Now, theres where i i have to be careful. Im not an attorney, sir, so i dont want to throw out language, the potential for language that could make it worse. But im happy to continue as we have many times work with this committee to hammer out language. Im going to ask you if the dea, as an agency, has a position supporting a change in legislation. I would ask that you convey the that to me, and im sure my colleagues would be interested, in writing yes, sir. The specific language that you believe would work better yes, sir. We cant understand what youre requesting if the agency doesnt request it clearly and with language attached. Yes, sir. I will do that. Thank you, ms. Ashley. Senator whitehouse. Yeah. To follow up on senator cruzs point, we had these conversations with dea when this bill was being developed. Ask we reached an agreement and we reached an agreement that dea signed off on that was approved by the administrator, that was approved by the attorney general of the United States on the recommendation of attorney general of the United States, was signed into law by the president of the United States. 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. Thats a little tough for us to work with. We are happy to try to do this and to try to make sure we get it right. But at the moment, the state of the record is that dea sign ised off on the bill as signed off on the bill as it is. Dea 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 try to get these basic questions answered so we can proceed. Now, your testimony has been that you have a bucket of tools and that you have not been hamstrung 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 that im not missing any. One is letters of add no to in addition. You can do letters of admonition more or less unilaterally, can you not . Yes, sir. And the second is you can call administrative hearings, and you can drag a distributer in to answer for their conduct, can you not . Yes, sir. And those would be informal hearings. Yes. And you can require a memorandum of understanding to be entered into by a registrant as a resolution of a dispute with dea, correct . That is correct, sir. And you can even demand voluntary surrender of the license so they have to just 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 their license, 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 that order to show cause is unilateral on your part. Providing ed. Yes, sir. Providing evidence. Yes, sir. Yes. And you can bring Civil Penalties, face civil action, take doj lawyers and go into court against them yes, sir. And, indeed, in 2017 you hit a report, 494 million in penalties against distributers, correct . Im not going to hold you to [laughter] pursuing Civil Penalties yes. Is and has been an enforcement technique against diversion. Yes, sir. Okay. And finally criminal actions, my information is you make about 1500 diversion cases a year in the criminal courts in which you have the requisite intent to show, and somebody actually is sanctioned, goes to jail, gets criminal fine levied against them for all of that. Yes, sir. 1500 per year. Average, sir. So if you have that kind of authority, then in the context the last time you did an iso of a distributer manufacturer was back in 201, 2012, correct . Yes, sir. And lets just say you were hesitant in 2015, the agency, because the bill that was coming up in 2016, 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 its centerpiece of your enforcement bucket of tools. Sir, if i could, if i could say that most of the isos and also orders of show cause on physicians and pharmacies historically theyve been used very sparingly on distributers and manufacturers. And theres a good reason for that, because usually distributers lets focus on distributers, because that was the purpose of this legislation. Yes, sir. Usually distributers arent a factor really in the direct diversion of pills unless 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 to dea where drugs are going in inexplicable numbers. I mean, how often do you see a during case where the opioid pills are directly leaving a distributer into the hands of the illicit user . It doesnt, sir. But what happens is the distributer is responsible correct. To exercise Due Diligence. Yes. So its a reporting and Due Diligence requirement, not a direct diversion issue, correct . Yes, sir, it leads to. Yes. And it could lead to the potential. Absolutely. On the part of pharmacy, on the part of the doctor pill milker on part of whatever is happening downstream where the opioid pill meets the illicit consumer exactly. Okay, great. We look forward to your recommendations. Were eager to hear them, but i will conclude by saying its incredibly frustrating to have the agency that signed off on this and supported it all the way through to the president of the United States now saying that it needs a change, but its unable to articulate what that change is. And at the same time, the parallel agency, 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 provide the report that weve asked for. So we will continue to make these inquiries. We really want to get this right. Thank you, sir. And thank you for your service. If they refuse to do it as to opposed to not having it done yet, i would be willing to follow up with you on that, because if we pass a law saying they a ought to make a report, they ought to make the report. Yeah. And the law had the date in it. Are you saying theyre actually never going to do the report . I have no idea. Theyre eight or ten months late right now. Okay. And theres no sign of it on the horizon. So it would be great if it was done timely, but okay. I think whats important is that we have the report that the law commands. Do you have reason to believe the dea have more than an acted . Id is difficult to answer senator. I dont believe so and the reason is when we conduct investigations we takes us on you go where the evidence takes us. Is there a drop off . For immediate suspension if youre speaking specifically about distributors that has been used very sparingly. So back to the numbers so the dea issued an average of 40 immediate suspension orders per year and enable the dea to stop shipments but only averages seven iso year . Is that right . 2014 . Yes. I understand there has not been the iso issue for a distributor or manufacturer opioid manufacturer since 2012 is there only reason those that have been the recipients of the iso . I can explain when investigators engage with distributors and manufacturers specifically we have the responsibility to make sure they have access we want to keep them in business to bring them into compliance only the most egregious we would use the immediate suspension order. So there were no manufacturers in 2012 the agency felt they should go after . We engage but we may have used a different tool as senator whitehouse mentioned there are other things we can do to bring them into compliance. In addition to the immediate suspension orders the dea has other authorities to revoke the registration of a drug company can you elaborate on this and their enforcement efforts . It is a tool that there is something egregious going on in the fact that it is not in the Public Interest for you to have a registration and needs to cease immediately but there is still a process that is drafted and the opportunity for a hearing and negotiations and conversations with the prosecutor it doesnt happen immediately but it is sparingly. I am interested and then to submit the corrective action plan what is the dea position on this and 2016 and how frequently over the past year . It is redundant and necessary and to bring a register into compliance so by the time you get to that corrective action plan we already have that. 194 million Civil Penalties and 2017. Can you tell me about the recent increase why the dea has been pursuing more Civil Penalties . Are there others out there that should pay that kind of money . If warranted yes. To disclose the evidence that supports that absolutely. There are three distributors. What are the other two . With the other cases against them. Are they pending now . One of them is and one is not. It comes down to the unintended consequences and it seems to involve the terms of substantial likelihood would you agree . Yes also the word immediate. And under discussing the dea to discuss those shipments immediately. When there is a substantial likelihood including the harm with those other types of harms . Can you give an idea how the dea defines the term substantial likelihood where they want to shutdown the drug shipment but they do not believe there is a substantial likelihood. But what the definition of the term and how it has diminished your ability to stop the shipment. The mission of the diversion investigator is to detect and prevent diversion while at the same time ensuring access to those that need it. So what the statute did was take away the prevention piece so what we want to do is take away the dea registration and therefore preventing. It change the standard yes. So you just have to meet a different standard so my question is how in practical terms . The situation where distributor with great knowledge with a controlled substances act not exercising Due Diligence, constructing shipments so they remain under the radar. So that is for the immediate suspension order. So we need to go upstream and work backwards. And show a substantial likelihood of some harm. But you had to show some before. It is foreseeable to someone that should not have them. Those who had violations previously. It is possible. Yes sir. My guess is the distributors were repeat offenders. Correct . Couldnt you use this law previously resulting from violation . This is the law of the land absolutely but what we would like to do is using legislation. You want to go back to the legislation previously. And in that provision to prevent diversion. Should congress provide more funding . Is that an obstacle in terms of diversion control and preventio prevention. And that additional tool is always grateful for Law Enforcement and we appreciate that. If congress could do one thing which would you recommend . That is a tough question. If it is a tough question then i gather funding is as important as a change in the law . Is. It is. Mr. Chairman if we need to make changes we need to know what specific changes you need to make if you could go after hhs at senator whitehouse goes through a list of other tools because we are focusing on the iso with the other tools such as criminal action and with the use of these other tools over time . That you can provide to us . You say iso is going down and there are other tools but 1500 cases compared to what . It sounds like you are going in the other direction. That is what i am going after. I would need to get back to you because there are so many. Is it your sense . But is it your sense dea has increased the use of these tools with this ongoing Opioid Crisis . Please provide us with some information i am interested what was provided to us from senator durbin it looks as though there is a decreased number of manufacturers for increased drug production is this temporary . Because that through 2017 there was a pretty high approval so what about 2017 and 18 . When we develop aggregate production quota every year we start over fresh. And we make that determination based on what the United States had a scientific need with all types of factors we met with senator durbin a couple of times having these conversations with other senators present but now we determine it was possible to reduce. It was actually emergency purposes only but we were able to reduce that again looking at what is required by statute for what is necessary to do the same thing again for the aggregate production quota. That is good going in the right direction because it is hard to believe 14 billion opioid pills per year i dont know how you go about determining what the country needs but the fact we are in a crisis and approvals are going down is a good thing. With your strategy attacking the Opioid Crisis and that we have been spared the worse and then to release the Initiative Action plan with Treatment Access data informed decisionmaking and policybased intervention so that is like 360 so based on your experience with the 360 strategy what is the most effective way to combat the Opioid Epidemic . I listed the six things hawaii has come up with. We have been very focused on engagement and enforcement especially when it comes to those who handle legitimately controlled substances. Continuing engagement to everyone who was listening to the community and the public i am over time. Have you worked with people in hawaii . Be make yes i have. Thank you mr. Chairman. We have two members i hope we can limit to five minutes for each of you i will start with senator hatch. We have a second panel and we need to give them time. I would like to start the second round raising concern it has come to my concern recently trying to make big pharma the next day tobacco then to bring multistate class actions against drug manufacturers and distributors turning them into villains. One of the leaders of this effort was quoted as saying the vilification of this industry has not even begun yet it will make the Companies Look like legitimate Business People but that they took advantage making billions of dollars from those who have died using their products. So some of the most vocal opponents of the legislation we are discussing today are serving as paid consultants that doesnt mean we should end but i dont want this committee to become a vehicle to carefully map out that litigation strategy. Trying to get the state attorneys general involved from the National Association lets be cognizant of what is going on. I have another chart over the last nine years that is as far back as i could get the data but the vertical line on the chart indicates ensuring the Patient Access act. First the data shows rather than those cause orders it increased by nearly 40 second, dea has issued more orders this year than at any time in the last nine years. So with the insurance Patient Access act has no type of slowdown, the insurance Patient Access act has where it previously did not exist. So why is it a problem for dea to meet a publicly known clearly defined standard when assuring the iso . Isnt that appropriate isnt that appropriate for them to know the standards they are held to . Senator, the new education that does not apply to the orders to show cause but the immediate suspension order. But to show cause is planned to come back to dea to explain the remedy with the changes they made to violations disclosed. At a hearing in september the dea was asked if they agree if congress repealed the insurance Patient Access act and did not supplement with Something Else and that wyatt raised concern comes to bear once again. But he replied yes sir, i do believe we need a mechanism at that level with respect to that tool. Do you agree that simply repealing the insurance Patient Access act not having any sort of action is not a viable course of action . Senator in our collaboration with doj we do believe the change should be made but what that looks like in the end will require additional conversation. Judge maloney was invited to testify at this hearing and was critical of insurance Patient Access act in this article as the basis of much of the criticism of the lot it is my understanding the agency declined to allow the judge to testify because Administrative Law judge are neutral and he is not in a position to testify is official or personal capacity so how do you square this position that he has already commented very publicly on this legislation and is quoted extensively in the media and within the agency . If the Administrative Law judge is not in a position to comment on legislation why is he in a position to write a law review excoriating a law he is tasked with adjudicating . These are the genomic questions they allowed him to publish his article . I am not aware of that. I can tell you dea has publication review boards i am not aware. What was deas reaction when it saw the article . Do you know . I dont. It is a common practice for judges to publicly talk about those tasks they are adjudicating . Why or why not . It may be that we have a process where it would be presented and once that approval is met then it can happen. Mr. Chairman i ask unanimous consent to enter several documents into the record the Pharmacist Survey the reports and the oped discussing the origins of the bill and Patient Access problems, and then the conduct by dea diversion control agents and paper copies of these two charts. Also to enter into the record explaining the need for this law the second was signed by 31 organizations. So ordered. Thank you for coming today. You are a brave american. You should ask whoever made you come for a pay raise. Who else is here with you today . Raise your hand. Who else is here from the Justice Department . Welcome to all of you. This example from senator durbin was from West Virginia, 9 million hydrocodone pills over two years sent to a single pharmacy in a town of 392 people. Are people. Are you familiar . Yes i am sir. That is breathtaking. The American People are watching this. In my opinion they dont care about the word immediately or imminent danger or interested in iso or csa or dea or nba. Or the nfl. What they want to know is how a federal agency or agencies allowed 9 million hydrocodone pills to be sent to a single pharmacy, not five or four but one pharmacy in a town of 392 people. That is 23000 pills per person 31 pills pills a day for every man woman and child in this town in West Virginia how can you allow that to happen . Do you know what the people of america are thinking they want to know how we are allowing this to happen so what planet did we parachuted from . How could the dea let this happen . You talked about all those pills. How could this happen . Sir, i hear you and i share your sentiment so do the men and women of dea i have the existing mayor and i hold him very close sitting right here. His name is omari. Welcome. And when we need him read the news report those who are harmed the most between 18 and 24. I agree but how does this happen . Since i have been back with my staff we have worked very hard to change the processes. This is insanity i heard the senate the senator say there are 14 billion pills distributed every year that is 43 pills for every man woman and child in america. Yes sir i agree we have to do Everything Possible and what we are doing today to have these conversations with these tools that could help the dea and Law Enforcement. I would like you to have makes decisions to send me a letter to 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 the town of 392 people. I am happy to do that. Yes or. Send a copy of that to me also. I would like one also. Ms. Ashley we are done with you at least for now and you have been very brave coming here and we know a lot of things are not in your hands that you tried to answer because you are the witness you received lung you may receive some questions in writing from those who are not here today they should be received in at least one week hand answer as soon as you can. Thank you very much. Thank you for your time today. While the next panel is coming i will introduce the next panel. This chambers is from the my outline fibromyalgia chronic pain organization notforprofit as the mission is to look at the fs loan efficacy programs to look at care and scientific research, diagnosis and treatment for people suffering from those diseases and chronic pain. Second is attorney general serving from the state of maryland since 2015 and with those cases involving Community Safety and predatory business practices. And marylands attorney general serving over 20 years. And in the state senate. In the house of representatives or the house of delegates. So now we have the executive director and of this capacity he is responsible for the oversight of National Association of pharmacies and by that association also responsible and also a registered pharmacist. In the last witness with a Healthcare Distribution Alliance and to see all operations and activities of the Healthcare Distribution Alliance and to go the way that i introduce from left to right. And allowing me to testify today to distinguish members of the committee. After hysterectomy surgery and for the following 16 months with nobody could touch me because of so much pain and to keep my legs and arms from touching each other and waiting for the days to pass. While Still Holding on i lost count of who could not diagnose two typed up a single page list of Health Problems i saw psychologists and doctors told me nobody could have that many things wrong with them. All the problems could be addressed. As well as taking it may share of daily life responsibilities. And completely understood. Every day was more painful. I kept thinking a body cannot experience so much pain. I could not ease my daughter alone and my husband if i take my life he does not deserve to rebuild his. Those thoughts kept me focused. Eventually i was diagnosed and treated for fibromyalgia and bayreuth cancer. I was fortunate. So in about 2005 to be significantly increase the enforcement and then difficulty filling prescriptions over a couple of years. And only having the patient organizations hearing about these distributors and prescribed hers being unsure why they are investigated by dea. Shutting down the pharmacies and doctors pharmacies patients are scared and in pain doctors reported the dea was Holding Meetings with prescribers to warn them about prescribing that they reported they were not clearly defined and ambiguous. The began asking for urine test and where they can get the prescription filled. They said they were nervous to treat patients for current pain because they dont know who was willing to get a prescription for opioids. And that families were fearful of them. But then to stop treating people of chronic pain. With that skyrocketing use paying for the opioids especially generic is cheaper than integrated Health Treatment and treatments and then to cause harm to them and then those colleagues under the investigation. I never could. The cbc guidelines were used with great fanfare. For these recommendations they are implementing them as if a hard practice rule harming people who have higher doses of prescription opioids that are documented between the doctor and the patient and the benefit managers. But quietly published by hhs. But in the minds of patients, they dont matter to federal officials. And with that chronic pain and that feeling of unwell this. They said they were not taking new patients that then had a double mastectomy for stage ii Breast Cancer tied to her lymph nodes. So to cause a Chilling Effect and with that scheduling of hydrocodone 12 of those Panel Members with those current imitations talking about the unintended consequences after several months passed to sponsor a national survey. Mr. Chairman and Ranking Member feinstein i am grateful to be here today to testify. Last month 43 of my colleagues and i regarding the insurance lung t12 then with a step backward of the collective efforts of the unlawful distribution with opioids with drug addiction and death. The dea is a vital federal partner for all attorneys general across the country. And it makes it more difficult to stop dangerous and illegal shipments of narcotics. In those suspected of illegal activity requiring the dea to have that corrective action plan and to suspend or revoke the registration of bad actors. And to be noted in part when those that were suffering from addiction to opioid. 200,000 americans have died from overdoses and opioids another 100,000 from other illicit drugs. Like fentanyl. It keeps getting worse. This year 2017 projected to reach 70000 death that is more than americans killed during the entire vietnam war. Just this year. Despite clear evidence with the manufacture of opioids is contributing to its severity. The letter from the state attorneys general is as follows. The act effectively strips of the missioncritical tool to have an immediate suspension order against the drug manufacturer or distributor whose unlawful conduct poses a danger. Under the controlled substances act having the authority to issue immediate suspension orders and the act alter the standard definition by requiring a substantial likelihood with abuse of a controlled substance. Essentially effectively vista rated the ability and judgment will rooney who has been cited often has all then likely impossible for them to suspend a distributor to fail to comply with the law. And by manufacturers and distributors to have new opportunities to avoid sanctions but to file a corrective action plan and dea is required at least 30 days. And with those proceedings. And to obtain additional chances. And they allow shoplifting those that are caught in the act the opportunity to outline how they intend to replace those items on the store shelves. And to fight this crisis is we must be careful not to over correct. And with those legitimate medical needs but my colleagues and i believe the act does not advance this goal. It just diminishes the ability to prevent the diversion. It has been said already the countries success of this threat state local federal authorities with the conflagration of Epic Proportions and to stand on the firehose. Thank you general and now doctor . Thank you chairman grassley and feinstein and senator hatch. Thank you for the opportunity to express our concerns about the law to appeal and modify the law. It was not one of the groups that jumped on the bandwagon once that article hit so back on september 5, 2014 we commented the law would have a detrimental impact to do irreparable damage with the authority of the dea. So the ability to act incisively is critical to protecting health. And repeatedly and effectively. And with this Public Health and safety of the epa. And with those agencies with these provisions as a controlled substance act to act with expediency and that data that they have supplied with those immediate suspension orders but there were nine Going Forward and the fact there was only a small percentage taken against the distributor industry that begs the question why was the problem . Where was the regulatory problem that mandated the definition be changed . And directed to pharmacies and patients . We heard those concerns we saw with those problems were but it did not appear to be the definition of imminent danger. Those offices across the state those cases i have assisted with our egregious activities with pharmacist in prescribers that are ultimately responsible for the death of patients. That access to controlled substances for legitimate purposes and legitimate patients are not issues and would not have been interrupted from those that are proposed and enacted. But these cases represent the minority of practitioners. Accrediting 700 wholesale distributors through our program. So to better understand that industry the efforts to confidently represent to have the process in place that are determined to be compliant with all federal and state laws. To be suspicious once again in the case to be involved in with an Expert Witness there was no question what constituted a suspicious order. And consistently conveyed it is an obfuscation of information with the attempt of meaningless paperwork. And to have a legitimate suspicious order it seems to be nothing more by reporting everything and anything. And those that need to be modified in a change of the law and enclosing for the hearing today and strongly urge the repeal of ensuring Patient Access of the Drug Enforcement act with the specific language changes but that corrective action plan language. And with those substance act. Thank you doctor. Thanks for the opportunity to come here to do this today. I represent hda and 35 primary wholesale drug distributors the final link between healthcare and pharmacy providers. As logistics experts to deliver all types of medicines chronic disease, cancer medicines and more to license Healthcare Professionals for their patience and with the supply chain partners including the 50 states. We dont prescribe dispenser demand this medicine and they agree with the condition with his academies addressing the overdose problem by the entire industry stakeholder. They are committed to the crisis with a comprehensive set of policies including those guidelines with the use of technology and data sharing. And with the information sharing by the dea. But over the past 11 years have that suspicious monitoring even though the regulation itself has not changed. And the requirement that many fractures have effective controls against a particular controlled substance. And then to collaborate with the dea it does not wish to undermine the Enforcement Authority or to look at any of its tools. With the opiate epidemic. And then to better flag with a customer orders. And to published guidelines and regulations with the effective systemwide strategy to understand where the agency is coming from. In june 2015 and without problem we told the Committee Last year the agency was slow and opaque. The immediate suspension order to serve as a background with a supply chain must have the registration from dea to handle these controlled substances. To revoke that it is to show cause. And with the alternative remedy. And then to have any control medication to issue the iso it has an imminent danger that definition was to the subjective reviewed after they suspended. Based on those activities with those shifting expectations and that supply chain Community Pharmacist have increasing difficulty to can obtain controlled substances. In 2016 they had the need for clarity. And to negotiate the law with transparency. And those with bipartisan support. And those of the repeal of all law. Casting in april 2016 with the enforcement efforts. And with that nationwide to reintroduce uncertainty. The dea is fully empowered with a wide range of tools and voluntary action with the criminal charges. And then with those changes to congress we will gladly work with you to identify the concerns if needed. And to have a small fraction of the medicines we do distribute. It has been a Long Time Coming thanks for letting me be here. 43 of the attorneys general including yourself the letter said that you either survey the dea ability to act so the first question doesnt take long to answer. And then to provide that data . Mr. Chairman yes and no is the answer. How differently the iso is used. But some of the common looking at the other end of the telescope you can see how few there are even before the that were in the Single Digits and to drop precipitously. So what that shows you is the iso is extremely infrequent to pass along that it is more difficulties one and with that fortyyear history that exist before last years act. What about the investigation . We just did a major case with them two weeks ago to bust the pill mills. We dont have the authority to stop distribution to catch it on the backend. But it is clear with the article written by the judge of those cases that are broad that it is unnecessary and at worse harmful. My first question may be confrontational but not second and third but advocating for change wasnt the agency trying to weaken the authority so your companies would not be shut down in the face of iso . Not at that time. Through the communication shutdown when they changed hands and i witnessed listening to the members that we talked about this to struggle mightily with determining and what is a suspicious order. This goes on for a number of years and in one case that i testify and the bottom line is it appears to the members the goal line was shifted and there was no way they could let kathy order to say this is suspicious i should report it. In fact i can tell you anecdotally one company met with a field office. You just answered my second question. Why wasnt the previous language sufficient to provide clear guidance . The guidance were two letters. That called for the reporting and suspicious orders. And then asking can you do regulations . And to submit over 40 questions three times to the agency with no answer. When the dea would not answer, yeah, that is or isnt a suspicious order, they would just cut off the pharmacies. Okay, this is my last question to you. Cant the distributers 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 licensed dea pharmacies. We dont ship to anything that doesnt have a dea license. I dont know be that answers your question, but thats the well, let me state it again, i dont think it does. Okay. Cant the distributers work effectively with the dea without limiting deas authority to make sure oh, absolutely. I think we can. Okay. And i will tell you this, since the change at dea, theres two deas, the dea between 2006 and 2016 and the dea today, i think our members would agree its been dramatically improveed. Is it because of this law or i dont know. Ive had my own on personal conversations, weve had our own meetings, there is clarity. I will tell you as an example, dea put out a wonderful meet manying a year ago and a young gentleman came in and discussed the masters case. You may or may not know the details of that. Its not important. But he outlined for all the registrants, everybody in the room, he said, look, here is this case. This is what were expecting on the appeal. This happens, this is how dea can use this case to enforce. That helped our members immensely to you said where the to understand where the lines were being drawn. And that all happened in the last 24 months. So it has improved, and were going to continue to work with hem. Senator feinstein. Thanks, mr. Chairman. Im from a medical family. My father was a yen surgeon, and my general surgeon, and my husband passed away a neurosurgeon. So im very well familiar with the term do no harm. In my view, this bill has tone harm. Has done harm. And i look at these figures, and i look at the answers that we got from the dea, and 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 position that ive taken, the one that my colleagues the 43 other attorneys general have taken, is that it ought to be repealed. We think it does do harm. There i think opioids are overprescribed and over, and taken too often in the United States. We are 4 of the worlds population. We consume 30 of the opiates, prescription opiates. And we experience 27 of Overdose Deaths in the world. Thats an extraordinary relationship. I mean, eight and a half were punch. Ing eight and a half times above our weight in terms of consumption and death. As everyone has noted, you know, 14 billion pills per year for our country, its way, way too many. And we have, of course, to strike a balance. We want to make sure that people who are suffering horrible pain get the relief they need, but were so far in the other direction that we need not just a course correction. I mean, the 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. Mr. 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 more cases over to the dea that theyve investigated and found. And perhaps if i can comment just a little bit further . Please. Theres either something wrong with the data or because simply the facts dont match. So if we have a situation where the committee and dea are reporting that the issuance of iso tos were a minimum against wholesale distributers four years prior to the enactment of the law, the industrys saying it was a device that was threatening or stopping shipments, something is not correct there. Either isos were being issued or not to, either the industry was being affected or not impacted by it. And then the other question senator kennedy asked, if you ship nine million dosage units to one pardon me city, where are the safeguards pharmacy, where are the safeguards . Whats the responsibility on the wholesale distributer in those cases, and thats where we think the law would need to be amended. Well, im looking at chart of iso suspension orders from 0817, and in 2011 there were 65, and i asked the question why, and it was the pill mills. And then it began to drift down. In 2014 it drifted down to Single Digits, and its 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 orders should be way up. And i, i dont know whether theres interference. I know theres money to be made, interference from pharmacy industry or to anyone else, but it appears to me based on these figures that the laws not working. Do you agree with that . Or to you find otherwise . Or do you find otherwise . We agree the laws are not working. Mr. Frosh . Absolutely, theyre not working, senator. We have so many well, 200,000 deaths since, since 2000, the year 2000. Two Million People in our country addicted to opioids. Theyre clearly not working. Mr. Gray . Well, as far as the laws, really since 2012, 2013 thats when, that was the High Water Mark for the West Virginia situation as a good example. And that was a systemic failure. From overprescribing, you know, we live as a Logistics Group we live in a pull system. Product it is pulled by the prescriber, filled by the pharmacists, and then the pharmacist orders to the wholesaler. And the wholesaler only ships to dealicensed groups. So and all the way down to the manufacturer there was a systemic failure of reporting. Our might bees based on the lawsuits members based on lawsuits in West Virginia did file this data with the dea, and yet there was no enforcement action. Now at the same time, i know for a fact that our companies were working overtime on these i. T. Systems, and what i would argue whats happened since 2012 and 2013, ive heard it quiet down, phone calls to me have quieted down, is theres less and less confrontation between dea agents, i believe, and my members. Because i think theyre doing, my members are doing the better job. Now that theyve selfdefined you really believe that. Yeah, today. With all of the pills that are out there, your members dont realize this is too many . No. Again, the dea sets that quota. The product comes in. We only ship on so if every 50 states in the union orders this product, its mathematically high, but we ship. And we are reporting our suspicious orders. And so there havent been Enforcement Actions, and i know theres been meetings about issues, but its not been, its not been polled on. I think, you know, i think as far as my 35 companies, its trending in the right direction to get this correct. My time is up. Thank you very much. Okay, thank you. Thank you. Senator hatch. Well, thank you, mr. Chairman. Madam cochairman. Id like to begin by thanking our witnesses for appearing here today. In particular id like to thank ms. Chambers whos a constituent of mine, and i appreciate her coming. I think youve played an Important Role in bringing this issue to my attention. And youve shown a lot of courage by being here today. I really appreciate it. Let me just ask many mr. Frosh, id like to ask about the letter you and a number of other state attorneys general signed calling for repeal of the bill. I find the letter curious because in making the case for repeal, the letter essentially relies exclusively on judge mull ruinnys article. It cites no data or, indeed, anything other than, other than judge mulroneys article in describing the laws impact. So my question is this what independent analysis of the law did you and your colleagues conduct before deciding to send the letter . Evidently you read judge mulroneys article. Did you do anything else . Yes, senator. First, let me say i found judge mulroneys article to be a very powerful and persuasive one, but there is no data since the law was passed, so we dont have that to work with. Yeah. But each one of us, all 44 of us are attorneys, and we looked at the law. And i know when you try to prove a case when a standard changes, its significant and that the change here 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. And that is a very, very high standard. Sure. And any lawyer can tell you it makes a big difference. So theres no Statistical Analysis that i can give you, but this is a legal analysis, and its shared by 43 other a. G. S, ask were evenly divided among republicans and democrats. O. K. Mr. Gray, the 215 gao report i referenced earlier described how an absence of clear guidance from dea to distribute canners regarding what distributers what constitutes a suspicious order right. And what can trigger an enforcement action was leading some distributers to decline to fill orders even when they had no evidence that a pharmacy or doctor was engaging in diversion. Can you explain to the committee how the absence of clear guidance was impacting distributers action and how the insuring Patient Access act addressed that particular problem . I can, and i think i just want the lead off by saying and following up with senator feinstein, i think the key to this law is, like any other law, we need to give it time and find out if there are issues, concerns. After 18 months this law has not been really tested in the marketplace. And i think time will tell. And if its appropriate then, we will go back and amend if you have to. But as far as the process that unfolded right. I mean, our members struggled between 2007 and 2012, 2013 by numerous attempts to have meetings. I went to one of them. Mr. [inaudible] didnt attend that meeting, and 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 orders, nature of suspicious orders, the things, you know, getting into the location of pharmacies, are they near pain clinics, are they near state borders and what have you. And weve received well, we submitted those questions three times, we till 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. Now, you indicated they cut, they stopped supplying with no evidence. I cant speak to an individual companys decisions, but i do know many of them i spoke with would call me after their dea meetings quite honestly terrified saying, look, you know, i think theyre going to pull my license, were not sure if this stuffs suspicious, its on the edge. Because the other problem is when our members submit to one pharmacy, a shipment of pills, we report that order whether its suspicious or not to the dea on a weekly basis. So the dea has that. But whats not told is that dea also has data regarding multiple other distributers. Because many pharmacies are served by more than one wholesale distributer. And so we thats called and dea has all this socalled arkansas cose data. I have asked dea for years can the dea look at us as partner in this and try to share some blinded data, our full data so you can see the full picture of a pharmacy so my wholesaler can look at it and say, all right, my shipment is kind of on the edge, but if theres three other wholesalers also submitting, well, its clearly in the realm of suspicious, and we should cut them off. I have been, you know, ive asked well, about three times formally can we do this, can we get together, and i keep getting answers that, you know, we cant blind the data, this, that and the other. I never have quite believed the legal argument they like to use, but thats fine. But i sure wish arcose data is a powerful tool and something that hasnt come up in this hearing, but sharing with the wholesale distributer would help clear a lot of this problem up. Ive said it for years. If the dea sat down with my 35 members and constructively used arcose 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 gotcha game weve been playing. Im glad to have your testimony. Weve heard recently from former dea officials expressing concerns about the insuring Patient Access act and ore aspects other aspects of deas actions with registrants. From your perspective, has communication with dea improved in the last 18 months since the insuring Patient Access act became law . Well, it absolutely has. With the change of personnel, i was able to open a line of communications with the head of the diversion control. We had several conversations personally, some of our meetings. The dea has been available for our conferences. They come and speak correctly to our members. And instead of bringing the old slide show which they showed ten years in a row, we now have new information theyre sharing with us which, i think, is a huge improvement. Moreover to, as i indicated earlier and demetra mentioned it, another stakeholder meeting in the spring. We had one a year and a half ago when that young attorney from their office came in to give his musings on the masters case and what it would mean if the dea won that case. Well, the dea won the case, which is great, but now my members at least have an idea what dea is thinking in terms of where the next legal boundary is. So i think its 1 is 00 improved in the 100 improved in the last 18 months. Yeah, i can be very complimentary of the dea since then. Not the case from 2006 to 2016. Well, thank you so much. Thank you. Appreciate it. Thanks, mr. Chairman. [inaudible] thank you, mr. Chairman. Id like to the ask the committee, and id like to finish on behalf of all of us on the committee, thank those of you on the panel who have testified today. The ongoing opioid addiction crisis is something that has harmed every single community, has affected every state. Just my small state of delaware lost more than 300 people who died in drug overdoses last year. And what were trying to do is to strike the right balance between making sure the people who suffer from persistent and chronic pain like ms. Chambers can get access to appropriatelyprescribed and managed opioids and those who are abusing them or misusing them are appropriately held to account. And so striking that balance is the purpose of our hearing here today, and id appreciate a few pointed answers to some simple, hopefully, pointed questions. To attorney general frosh, delaware under the leadership of our attorney general recently enacted new regulations that allow prescribers to better monitor each opioid prescription. And it limits an adult from receiving a firsttime prescription for more than seven days. Except under exceptional circumstances. So, and thats led to a 12 decrease in the number of opioid prescriptions just since april 1. Shouldnt we be looking at some of the positive, innovative work thats being done in states like delaware . Yes, absolutely. A number of states have Prescription Drug monitoring programs. They can be extraordinarily effective despite the fact that laws like that have been enacted in delaware and across the country, we still have this tidal wave of opioids washing across, and those are important steps forward, but we have a lot of work that remains to be done. So help me, attorney general frosh are, dr. Catizone, if you would. 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 misprescription of opioids . I dont think they are. I mean, and you only have look at the results to come to that conclusion. Dea has essentially had the same tools for four decades, and they have not been sufficient to overcome wave of opioids that has washed across the country. So i would say not. Now, you know, the prescription that i would give is holistic. We not only needfect i Law Enforcement need effective Law Enforcement, but we also need treatment, we need Prescription Drug monitoring. We dont have nearly enough treatment beds in our country, and, you know, were not making forward progress. Were making progress, but its incremental. It needs to be much more rapid. I agree with you. Dr. Catizone, what else do you think dea should do or what else can we do as a committee and a society to address the significant problem of opioid addiction . I think the answer is the balance that you spoke about. We need to have a balance between access, but effective Law Enforcement. And to the prior question, we havent had time to analyze the data the committee presented today, but if you look at an overview, the deas taken actions in other compares to compensate for the inability to have concern about trying to take an iso. So there has to be some balance there as well. Isos should be restricted to the most serious, egregious cases where patients are going to be killed if that pharmacy, that doctor continues to operate. You saw by the data the amount of times the isos were very limited, so we think restoring or eliminating that new standard is a means that would give the dea that important tool back to use that in very limited, but very serious situations. Mr. Gray, you represent distributers. This is been a lot of concerns theres been a lot of concerns expressed today on both sides about insuring Patient Access and effective Drug Enforcement act. How do you think we can fix it . How do you think we can improve and sustain that working relationship that that you just talked about with the dea to crack down on inappropriate overprescribing behavior . Yeah. And to make sure that those who are genuinely in pain like ms. Chambers are able to access the prescription opioids they need . Well, first let me say that the dea, i think, does agree with us, there needs to be some definition of imminent danger. If its not the right one in the law, then we should fix it. But as i said, let time see how that works out. And it may have been a rush to judgment, i agree with someone on the panel alluded to it, its probably not the most judicious way to do legislation. But that being said, yeah, i personally believe we can talk about the mechanics of Law Enforcement and pape management, but from personal experience and this just happened to me in the last 96 hours, i spent 24 hours in a Major Hospital here to have this shoulder ive had, i now understand pain. I never understood persistent pain. Since august 3rd i have had 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 bone for the second time and then scope out this shoulder. And in the hospital in that 24hour 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 . And i looked at these people and i said this isnt about the pain. Pain will take care of itself. Well, you need to give me a number. Whats your pain . So i began making up numbers. And then when they sent me out of the hospital after 24 hours with a prescription of oxycodone , we couldnt get it filled. My insurer wouldnt pay for it. And so its like, well, you know . So i paid for it, and i used about five of them, and thats it. Im off it now because its not good stuff. But it did immediately after surgery. But, you know, its a problem beginning with the medical community, if you ask me. Im not picking on them, but the bottom line is there has become a pattern in the medical community that Pain Management heals, makes healing go faster. Mr. Gray, let me just reask my last question, if i might. Yeah. You concluded with what seemed an intriguing possibility, that the distributedders and dea could distributers and dea could Work Together to allow the continued delivery of needed pain medication to those who legitimately need it. I have firmly held, you know, if the dea opened the door and said lets wok work with you as registrant, not as a criminal as we used to be twined by someone in that agency, if we worked as a registrant, i actually believe between the resources and the access of information that my members have and in the Bigger Picture of information dea has, this shouldnt be a problem to identify the bad players. I appreciate your testimony, but, you know, as you represent yeah. Those who struggle with pain 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 appropriately and distributers, we have to get this right. We have to work it out, and we need a sense of urgency about it because there are, literally, people dying and suffering needlessly. Thank you, mr. Chairman. Senator hatch had one other thing he wanted to do. No, no, i just want to thank you all for being here. Just wanted to thank you all for being here and for your testimony and for your help to this committee. Its with been, its been great. These are this is a really important subject, and were all concerned about it, so weve learned a lot here today. Ms. Chambers, were you trying to get our attention . Yes. Yes, sir, chairman. I have three quick points. The patients really want this law. We are so grateful that it has come about, and ask you guys have to talk to each other. We want the dea and the distributers and the doctors and everybody to be talking so that they know what the problems are and that they have communication about what the exact definitions are of when a distributer is in violation or what theyre looking for. This hasnt happened in the past. We need this. Patients need access. My second point is that prescription opioids are only a part of the opioid issues. The illegal Opioid Epidemic in the United States. Theres a lot more thats going on besides that. And the third is i wish senator kennedy was still here because the answer to his question is that if we have the cart before the horse, if we took money and put it into Pain Research, we wouldnt need so many opioids. Please, i hope every member of congress understands, we dont have enough money. Its Something Like six cents per patient on pawn research in america. Nih needs a Pain Research institute. We need to pour money into different pain treatments. Patients dont care whether or not we have opioids be we have another pain 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. Yeah, thank you. And thank all of you for your preparation and your delivery and answering questions. And remember what i said to the first panel, you may get questions over the next week for answer in writing. So, staff, notify all members to get your questions in soon. If you do, wed appreciate your response. Thank you very much. Meeting adjourned. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] tonight on cspan2, interviews with senator mark warner of virginia and white house Economic Advisor gary cohn. Former secretary of state Madeleine Albright and other Foreign Policy analysts discuss u. S. Global leadership. And later, a house hearing on funding for Downs Syndrome research. Thursday morning senator mark wearn told an interviewer that he believes congress in 2018 will pass a bill to fix problems with the tax reform bill. He also answered questions about the russia investigation and next years midterm elections. The interviewer is mike allen of axios. This is a half hour. Morning and welcome to the festive edition