Transcripts For CSPAN Prescription Drugs Law Enforcement And The Opioid Epidemic 20171213

Will come, everybody and thank you for your attendance, particularly those who have to testify and answer questions for us because i know you put in a lot of extra work to be ready for it. This hearing is on the oversight of a bill that has a long name called ensuring Patient Access and effective Drug Enforcement act. Somebody is going to have a pronunciation for the acronym, but i will refer to it as the law, or the bill. I am eager to hear from all of our witnesses today. See this lawto repealed. Others insist that it should remain in place. I have not made my mind up on the issue, so i am interested in hearing both sides of the argument. This discussion is particularly important, giving the continuing Opioid Epidemic that has ravaged this country through the past several years. I do have concerns with how we , and the we are today discussions we are having today. When Congress Took this bill up in 2015 and 2016, there was little to no fanfare about the proposal. Billasic goal of the seemed very modest. Theide a definition for term, imminent danger. Distributors and other providers would have more clear guidance for what was required of them before dea could issue an immediate suspension order called iso. Can be industry an iso a death sentence. From their standpoint, the clarification seem not only fair, but a necessary step in helping figure out how to comply with the law. There was another practical concern, that of ordinary patients with legitimate needs accessaccess or losing to essential prescriptions if legitimate distributors were shut down. Dea understandably had some concerns about curbing their enforcement powers. Undefinedlimited, Enforcement Authority needed some refinement. Had litigation risks with such undefined authority. An interest in working towards amending the language to reduce their own risk. My understanding was that dea provided Technical Assistance to both house and senate staff for other members who were responsible for drafting the bill. Admitted as much in testimony before the house of representatives of october of this year. When the bill came to the senate, it was referred to this committee. I took up the bill of in part on assurances from dea and the department of justice that they we discharged the bill from committee and we did that by unanimous vote the build been passed the senate by unanimous consent. It also passed the house by unanimous consent. President obama signed the bill into law april, 2016. Dea testified that they advised president obama to do just that. So let me be clear. Or department of justice did not want this bill, i would not have taken it up, period. Than the Washington Post and 60 minutes ran pieces criticizing the new law. Both stories highlighted former quoted a law and review article from the acting chief Administrative Law judge for dea. The reports in the media suggest that congress was in the back pocket of the opioid industry. And that this bill was a giveaway to the Prescription Drug industry. So as i have described, it should be fair to everybody to fairly clear for everybody to see that nothing could be further from the truth. I have worked hard my entire career trying to combat illegal drug trafficking. My friend here from california and i have worked together on a group called the drug caucus to do just that, besides the work we do in this committee. We did it to provide more effective ways for Law Enforcement to do their job in the Drug Enforcement area. I am especially frustrated by the dea itself, which Gave Congress a goahead to enact this legislation. We would not be here today if the dea told us that they objected. Suggest reports also that the law of effectively stripped dea of its enforcement power. The data appears to show otherwise. In otherior to the passing of te bill, between the years 2011 and 2015, the amount of immediate suspenon dramatically decreased since the law was , the amount of immediate suspension orders has increased. Moreover, the number of opiates decreaseed overall between 2016 and 2017, which all comes after passage of the bill. Law didaid that the not stop dea from doing its job in the diversion space. Even though this bill was vetted by congress once, we all have to be open, at least i am open to reexamining the criticism of hence, we are here and i am looking forward to the hearing. Words, what the criticisms of the law are. We should not be repealing laws just because the lightest person in the worm but we should not be repealing laws just because the loudest person 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 lawyer, who are suing the industry. His objectivity could be questioned. The sensational news stories failed to question this conflict of interest. I look forward to hearing the testimony from the witnesses and finding new ways to strengthen our Law Enforcement efforts without preventing legitimate access to medications that real patients with real, legal prescriptions need. Opioids continued to be a huge problem in this country. It is vital that our federal laws keep up with the best way to combat illegal opioid use. Before we start, i have a prepared statement from congressman tom marino, author of this legislation and original cosponsor of the bill. He introduced the house version. I have a statement from congressman tom marino that im going to enter into the record without objection. Now senator feinstein. Sen. Feinstein thanks very much, mr. Chairman. Im very disappointed that neither the dea nor the Justice Department would allow dea chief Administrative Law judge mulroney, who wrote a law review article that was critical of this law, to testify. In that regard, im going to put in the record a letter dated december 12 from an assistant attorney general, who did not bother decided himself and i cant make out the handwriting of the person who did but essentially saying, we have other people and they will not make them available. It is the first time in 25 years i have had this kind of thing, where somebody we wanted to be a witness was not permitted to come before the committee. And 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 with it. Recent news reports claim that this bill, which was enacted in 2016, is partially to blame for this struggle. The law does four things, and let me point them out. It outlines the conditions that must be met by drug manufacturers and distributors in order to obtain a dea registration. Two, it defines what imminent danger to the Public Health or safety. 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 a 2015 gao report, which made three recommendations to dea about how to improve communication with registrants in order to ensure better compliance with this law. Dea has not yet implemented these recommendations. That is my understanding. Third, the law allows registrants to submit a corrective action plan prior to dea revoking or suspending the registrations. However, it also stipulates that when an imminent danger exists, dea may immediately suspend a registration, even if the registrant submits a correction action plan. Finally, the law required by the department of health and Human Services to report to congress on how Law Enforcement can better collaborate with the pharmaceutical industry to increase Patient Access and prevent drug diversion. The department is eight months late 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 the dea Enforcement Actions, while now starting to increase, began declining well before this law was enacted. Between 2011 and 2016, immediate suspension orders filed against pharmacies went from 21 to four , and those filed against practitioners went from 43 to five. The last time an immediate suspension order was filed against a manufacturer or distributor and this order immediately stopped the distribution of pills was guess what 2012. Between 2010 and 2016, Civil Penalties levied against distributors dropped from 3. 1 million to a mere 115,000. Sounds to me like something is not working. So during the same years that we saw opioid Overdose Deaths increase by 57 , deas Enforcement Actions, in many categories substantially declined. What i want to know is why. Something is not working. It needs to be fixed. If it is not the law and i have asked dea and the Justice Department for their assistance in looking at the law then we need to figure out where the problems lie. I have been struck by the examples of negligent distributors raised in recent hearings and roundtables. Let me give you an example. In a two your period, nearly 9 million opioids were delivered to a single pharmacy in 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 that state. The result . A reported 17 billion profit for distribution companies. And here is the price. 1728 fatal overdoses over six years. 1728 fatal overdoses versus a 17 billion profit for distributors. Consequently, many distributors faced and settled lawsuits with the state. Yet almost all of them maintained that prescribers, pharmacies, and Law Enforcement are better situated than they are to prevent diversion. It is hard to imagine a circumstance under which a request for 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 act require manufacturers and distributors to conduct Due Diligence of their customers, to detect and disclose suspicious orders to dea, and to keep complete and accurate records relating to the manufacturer or distribution of controlled substances. It may well be the dea needs to issue more guidance as to what constitutes a suspicious order. But these examples illustrate the fact that some distributors appear to be more concerned with their bottom line than fulfilling their responsibilities under this law. Bottom line, we cant turn a blind eye to this kind of reckless disregard. And Law Enforcement must actively pursue these kinds of cases. With that, i look forward to hearing from our witneesinue, ld gentlemen, to lose more than 33,000 americans each year to an epidemic that is entirely preventable. Thank you, mr. Chairman. Sen. Grassley i want to associate myself with the disappointment that senator feinstein expressed that the witness we asked to come was denied coming by the administration. And today, we sent a letter to ask reasons why, because we did not get proper justification. Of course, now writing that letter does not do any good except to give us justifiable reason, if they have one, and i doubt if they do. If it is ok with my colleagues, i want to call on senator hatch before i introduce our witness because of his leadership on this issue. So would you proceed, senator hatch . Sen. Hatch thank you, mr. Chairman, for holding this hearing and allowing me to make a statement. Too often in this town, narrative gets ahead of facts. This paper prints an explosive heading and it is often the races. It does not matter what the actual facts are. The bandwagon starts rolling and Everyone Wants on or off as the case may be. I was surprised and disappointed by how quickly everyone seemed to start running from this bill the moment some negative news reports came out. From senator mccaskill to senator manchin to attorney general sessions, it seems like everyone is 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 were offered an amendment to change the bill. To the contrary, the bill passed this committee by voice vote and passed the full senate by unanimous consent. These last two months have been deeply frustrating to me. I wish some of my colleagues would stop trying to rewrite history or pretend this was some sort of shell game. That is why i am glad we are holding this hearing. I want to talk about the facts of this law, the fact of my involvement and of this committees involvement, and the facts of the laws impact. Lets start with the impetus of this law. This law came about not because i were anyone else got some giant check, but because of very real concerns that the way dea was operating was threatening Patient Access. Representative marino has said he became involved after meeting with a Community Pharmacist in his district who was having so much trouble obtaining prescription opioids that he had to turn away legitimate patients. I heard similar concerns from constituents, one of whom will be testifying today. It was not just utah and pennsylvania. Across the nation, pharmacies were facing supply chain problems. A january 2014 survey by the National Community of Pharmacists Association found that 75 of respondents had experienced three or more problems with stopped shipments in the previous 18 months and that a majority had to turn patients away as a result. News reports from indiana to florida detail stories of legitimate patients who were having significant difficulty obtaining needed medication. No doubt the supply chain problems have multiple causes, but deas activities were contributed factor. According to a 2015 gao report, the lack of clear guidance from dea to distributors on what constitutes a suspicious order and what can trigger an enforcement action was leading disturbing errors to place quotas on drug shipments to pharmacies, a practice the report found can negatively impact patients access. The report detailed how fear of Enforcement Actions coupled with lack of Agency Guidance was leading distributors to decline to fill orders, even in cases where distributor had no evidence that a pharmacy or doctor was engaging in diversion. It was not just elective guidance. I have had a number of individuals tell me that deas attitude to registrants during this period was downright antagonistic. I have a letter from a professor that describes some really troubling conduct by divergent control agents and that explains how difficult he found it to try to work with the agency in good faith. It was not just the private sector having difficulty dealing with the dea. In a separate 2015 report about drug shortages, gao described the great difficulty it had getting information from deas office of divergent control. According to the report, completion of gaos work was delayed significantly because of deas refusal to comply with gaos request of information for over a year. Only after the intervention of senior doj management officials was gao able to obtain the data it was seeking. The ensuring Patient Access act was intended to provide clearer guidance for supply chain members, and to encourage greater cooperation between the dea and the requested community. That is why it defined the agencys immediate suspension Order Authority and why it provided for corrective action plans. This was not some effort to help Drug Companies go people. To help Drug Companies kill people. Give me a break. This was an effort to ensure that deas praiseworthy efforts to stop abuse do not hurt legitimate patients. I would like to say a word about how this law came together. I want to be clear right at the outset that this was not a pharma bill. Dont tell me i did this bill because pharma donated however much money to me. Prior to its introduction, senator whitehouse and i negotiated with dea distributors and Patient Advocacy groups. We may have talked to a Pharma Company at one point or another, but they were not key players. The bill senator whitehouse and i introduced, doj was ok with it. They said so in writing to this committee. Of course, legislation is a process and after introduction, i thought it was necessary to make changes to move the bill forward. I would have preferred not to, but we all know that legislation requires compromise, so i had to accommodate some requests from industry 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. 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 what dea had asked me to tell them and made the floor and record statements i had 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 saying they still had some concerns with the bill. For reasons i dont understand, they never shared these concerns directly with me. But evidently, the concerns were not that significant, as dea did not try to stop the bill. As all of us on this committee know, any bill can be stopped by agency opposition. All it takes is one hold. That is how we got here. The bill addressed a very real problem and did so in a carefully crafted, negotiated way. If dea has concerns with the bill, i am happy to hear them. I also asked dea to explain why those concerns did not cause it to stop the bill 18 months ago before it became law. With that, i thank you for allowing me to make these comments, mr. Chair. I will only speak briefly. I accept and adopt the remarks of senator hatch. The only thing i would add is, in addition to everything he had said, we even then built a backstop into this bill to make sure that there was no harm from it. We gave responsibility for that backstop to a different agency. They were given the legal obligation to do a report on what the result of this bill was. They are now late and in violation of law. They have not provided that report. I think it would be very helpful if we were having this hearing with the legally required hhs report that we demanded. I think it is fine to go ahead without it, given that they have delayed, but this would be a more respective hearing with it. It was a strong signal that we really wanted to get this right. I am not going to introduce our first witness, miss ashley. And then i will swear her in and , we will listen to her testimony. Then we will have questions of her. She represents the u. S. Drug enforcement administration. Is currently the acting assistant administrator in a division of that agency and has worked within that agency for now over 30 years. As acting assistant administrator for dea, miss ashley oversees investigations and influences National Security staff, government agencies, media, and private organizations on matters related to the diversion of controlled substances. Would you please stand . Do you affirm that the testimony you are about to give before the committee will be the truth, the whole truth, and nothing but the truth, so help you god . Thank you. You may proceed with your testimony. As usual, if you have a longer testimony, it will be placed on the record. Try to sum up, as soon as you can, after that time happens. The red button. [laughter] ms. Ashley distinguished members of the committee, thank you for the opportunity to discuss the insurance act of the Drug Enforcement act. This legislation altered the government, the manner in which dea ceased to revoke registration against those who continued whose continued authority is no longer consistent with Public Interest. Sadly over the past 17 years, our nation has been devastated by opioid abuse more than 300,000 opioid related deaths. The epidemic has created a generation of abusers, currently estimated at 12 million. While prescriptions for schedule to opioids have begun to twoine, making schedule opioids less accessible mexican , drug cartels had filled the void by offering cheap heroin. The results are tragic with a record 64,000 estimated overdosed deaths in 2016. I want to assure this committee that the ea uses all tools, dea uses all tools, administrative, civil, and criminal to ensure its 1. 7 million registrants comply with the law. Since 2011, dea has revoked nearly 1000 registrations each year. Immediate suspension orders and voluntary surrenders. Isos are used judiciously and have historically been used against those responsible for causing harm in the community. Doctors writing illegitimate prescriptions in pharmacies that fill those prescriptions. With someone with 30 years of experience as an investigation and now head of the dea Diversion Control Division i , have used all of these tools to counter the drugs, the diversion of controlled Prescription Drugs. Isos are not our only tool. We have also aggressively pursued civil actions to ensure compliance with us. Dea has levered nearly 390 million. In memorandums of agreement with each distributor to ensure that they report suspicious orders. The same distributors are now the subject of investigation by a coalition of 41 states us ernies states attorneys. The dea is sharing information in support of those investigations. Dea has also prioritized criminal investigators by embedding them beside the version investigators and is called tactical diversion squads. These groups are dedicated to dismantling individual organizations involved in diversion schemes. Since dea has more than doubled 2011, the number of tactical diversion squads. We have a pleasant total of last 77. Week, we announced the results of operation. Its a key. This ongoing effort targeted 26 Operation Full pharmacy. This ongoing effort targeted 26 pharmacies in california, nevada and hawaii. , todays ongoing effort has resulted in 23 arrest, 4. 3 million in cash, and most importantly, for purposes of this hearing 10 voluntary , surrenders of pharmacy registrations. We are also scheduled to increase the number of technical diversion squads to 100 by 2019. The Diversion Control Division also works closely to educate of regulatory requirements under the controlled substances act. We currently completed a mission wife recently completed a nationwide initiative to raise awareness on the role that pharmacists play in filling valid prescriptions. We offered this training free of charge in all 50 states, the district of columbia, and puerto rico. 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 is this impacting the dea . While it has not prevented as us from issuing isos, we have issued nine since bill costs enactment. Bills enactment. The new standard makes it more difficult to issue an iso to noncompliant manufacturers and distributors. This law has changed the manner in which dea pursues orders. The law now gives the register an opportunity to implement a corrective action plan. A very small percentage of registrants who been subject of an order to show proceedings have submitted a corrective beenn plan, and none have approved. Regardless of the Legal Framework in which we operate, dea will continue to work to combat this devastating Opioid 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. For your commitment to combating this epidemic, and i look forward to your questions. Sen. Grassley thank you. Miss ashley we will have five , rounds of questions. Leading into my first question, i am not going to repeat a lot of stuff i made in my opening statement. It adds up to the fact that when this law was passed, it was not controversial. So my first question is, my understanding is, the dea is in favor of changes to the law but would not give congress and , 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 be a Pretty Simple question. Do you favor amending it in some way . Ms. Ashley im sorry. Senator in collaboration, dea , and the department of justice are in agreement with a change. And that change what that change will look like ultimately is going to require further discussion. But what we believe now, we are leaning more towards just amending it. Host making change sen. Grassley making changes . Ms. Ashley yes just making , changes to the existing. Sen. Grassley 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 that is now law . Ms. Ashley sir i am in a , difficult position because i was not present for any of those conversations. And to that measure, neither a different it was administrations. It is difficult for me to try to piece together for the who the conversations were with, and how they went about. I can tell you here today, i can give you a feel of how it has made it harder. And that is since its enactment, because that is when i came on board. Since its enactment. Sen. Grassley thank you. Youll see we have a chart up , here. Both senators made references to some of the suitors, as i did. This data was provided by dea, showing the number of immediate suspension orders or isos or isos between years 2011 and 2017. The data shows that isos went down dramatically between 2011 and 2015. In 2011, dea initiated 65 isos. A couple questions. Doesnt this data pretty clearly show that this particular bill had no effect on deas enforcement ability . Would you say, in answering that question, that the data directly contradicts the claim that congress effectively stripped the dea of its most potent weapon by enacting the legislation . And that the law made it virtually impossible for the dea to free suspicious narcotic shipments . Ms. Ashley i am careful not to conflate the two. We go where the evidence takes us. We do what needs to be done is the bottom line. If in order to show cause is not wanted at the time, that is not the direction we go in. I do not want to conflate the two. It could have increased in another area. We have several tools in our toolbox. When dea engages with a registrant, we have the responsibility to detect and prevent diversion. We also have the responsibility to ensure that medicine gets where it is supposed to be, that access is available. When we engage, we may have made the decision to administer a letter of admonition or do in a memorandum of agreement, or to do in informal hearing. Not necessarily wanting to conflate the two because order to show causes may have gone down, but it may have gone up in another area. Sen. Grassley 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 build is not stop dea from doing its job in the diversion space. Isnt that some of the else in the department saying that, isnt that right . He also testified at the same hearing that the data did not show that the law fueled the Opioid Epidemic. Isnt that right . That is coming from somebody in your department. Ms. Ashley i agree wholeheartedly that it does not stop us from doing our job. We find a way. This committee, the speakers have already stated that this is an Opioid Epidemic. We use every pool within our every tool within our boundaries to combat this problem. Sen. Grassley this will be my last question. How exactly has the dea had to change its procedures after the bill was enacted. Ms. Ashley prior to the legislation, our mindset was to pursue these types of investigations from a preventative measure. I will give you the example that was part of brought up earlier, shipping 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 make a determination whether the controlled substances that they are handling, that they are accountable for, and to make sure to prevent any diversion. Prior to the law, if there were distributors who would do these types of things and send millions of those units to a pharmacy, not report suspicious orders we have found internal documentation that would state, giving guidelines on how to circumvent the regulation. Prior to the law, that was enough ground for an order to show cause. Now that the law has passed, it states it has to be a substantial likelihood of an issue, and it has to be immediate and it has to show abuse. If i could give you this example of a distributor of a patient who has died. Getting a prescription from a pharmacy, the pharmacy the patient fills the prescription at the pharmacy. Someone dies. With the law in place now, i need to make a connection between that distributor and a death. Versus prior to the legislation, i could do it on the prevention level. This is before the bill. I can start an immediate suspension order on the distributor before it leaks out and gets down and connects to a death. The legislation now states that there must be death, serious bodily harm or abuse. Prior to that, it was diversion. Sen. Grassley senator feinstein, and then i will step out for a minute. After that, senator hatch. Sen. Feinstein thank you, mr. Chairman. I am looking at the immediate suspension orders from 2008 to 2017. 2011, there were 65. 2017, there were six. In 2015, 33,000 people died of overdoses. There were five. I looked at the production quotas, and there are four criteria. These factors do not include terms of abuse or overdose death rates for specific classes of drugs. They should. How do we keep functioning and let this happen . Ms. Ashley senator, if i could answer the question in two parts, first addressing the immediate suspension orders. I will go back to investigators going where the evidence takes us. If an immediate suspension order is unwarranted, that is where we pursue the investigation. In speaking to the quotas, the difference is im sorry. Your question in the beginning regarding the quotas. Sen. Feinstein the quotas do not include trends of abuse or overdose death rates, or specific classes of drugs. Why not . Ms. Ashley i recall. That is something we have to be careful about. We want to ensure an adequate supply. In making the determination of the trends, we are bound by statute when we make when we determine what it will be. Something has to be there. I would need to take back to our quarter section and our office to have a lengthy discussion about how that type of thing can be added into what the statute already exists. Sen. Feinstein i take this with the greatest sense of alarm that we have all these deaths going on and nothing changes. I think your answer is really not a good answer. Every alarm signal is out. People are dying from the tens and thousands. Yet, the shipments go on and dea is not doing its job. Ms. Ashley senator, if i could respond to that. Again, we are bound by statute when it comes to quota. There is something we can do on that subject. If the dea can determine that the specific Manufacturers Product has been tied to proliferation of drugs in one community sen. Feinstein in the West Virginia case. Ms. Ashley in that circumstance, what did happen this is after a drug is identified we can decrease their quota. I hear you, senator. I understand and i would like to take that back and continue to work with your committee. Sen. Feinstein presently, a small pharmacy can receive millions of pills and nothing happens. Ms. Ashley that is not the way it should work. Sen. Feinstein it is working that way. You just said that is the way it works. Ms. Ashley a distributor is responsible to exercise Due Diligence. They have an accountability over the shipments they send out. That is where dea comes in with the oversight. Sen. Feinstein when 33,000 people die in a year over overdoses, maybe a few distributors should be shut down. That is the way i feel. I think this whole view of business as usual is just not working. The administration really becomes liable for not making the changes that are necessary to prevent these Overdose Deaths from happening. I have never said this before. I have been on this committee for a long time, but i have for a long time, but i have never seen a more lax obstet operation. I cannot help but say that. And people die because of it, i get really angry. Thank you. Sen. Hatch before i begin, i would like to ask if we could get a second round of questions for this witness after everyone has had the opportunity to go. Sen. Grassley i think we will have time for that. I will make a judgment. We will see how many members come. Right now, i think we can. Sen. Hatch i have a number of questions for her. I would like to start by talking about the immediate recession order or isos. They gutted deas ability to issue isos and caused Enforcement Actions to plummet. Lets look at the actual data. I have a chart here of isos issued by dea over the last 10 years. This data comes from dea. I have given you a copy to refer to. Isos start in the low double digits in 2008, peak in 2011, and decline around 2014 before stabilizing thereafter. The vertical line indicates where the ensuring Patient Access act was passed. When you look at this chart, years. Which shows that the decline began four years before the ensuring Patient Access act. Is there any conceivable way that the act could have caused the decline in isos . Ms. Ashley senator, this is a tool that the dea has used sparingly. Again, we move where the evidence takes us. They have been used sparingly but also predominantly for physicians and for pharmacies. It is a difficult challenge to connect a distributor and immediate sen. Hatch i was asking for a yes or no answer. Ms. Ashley has it changed . Has it impacted our ability to issue isos . No, sir, it has not. Sen. Hatch the dea issued more isos in 2017, the year before the act passed than it did in 2015, year before it passed. Let me direct your attention to the orange bars on the chart. These represent isos against distributors and manufacturers. The blue bars are total isos. Isos against distributors have been a particular focus of news reports criticizing the bill. These reports have described the isos as deas most effective tool against large Drug Companies. When the act passed in 2016, how many years had it been dea had issued an iso against a distributor or manufacturer . Ms. Ashley the last one was 2012, sir. Sen. Hatch the fact that it had been just under threeandahalf years, as i see it. Not only could this law not possibly have caused the decline in isos, but at the same time the law passed, it had been over three years since dea had issued an iso against a distributor or manufacturer. Simply put, the notion that isos against distributors and manufacturers were a frequently used tool for the act passed and that the act caused deas use of the tool to decline is simply not true, would you agree . Ms. Ashley yes. Sen. Hatch over the last decade, the most isos against distributors was three. There has also been criticism of the acts requirement that dea notify companies of the ability to submit a corrective action when issuing a show cause order. Judgment rudy used some language in his article saying it was akin to allowing bank robbers to round up and return ink stained money and agree not to rob any more. I have to say that is a bit much. The purpose of this was to encourage greater cooperation between dea and supply chain members. It was to avoid a situation from doctors and pharmacists were facing in which dea would not allow them to present any evidence of corrective action, lest they first excepted responsibility for all of the conduct dea had alleged, even if the doctor or pharmacy had not committed all of the alleged conduct. Just to clarify, corrective action plan provision applies only to show cause orders. There is no requirement in the act that dea provide an opportunity to submit a corrective action plan before issuing an iso. Suggestions to the contrary are incorrect. I have another chart. I will have to wait. Sen. Leahy this is troubling. Obviously, dea or someone totally dropped the ball in West Virginia. Deaths occurred. People selling the drugs made a lot of money. They knew they were selling more than they could conceivably be a need for. The legislation we are talking about has house and senate dea opposed it when asked. The whole thing is so murky that the people selling, pharmaceuticals, are the ones that are coming out well in all of this. There has been a lot of discussion regarding the use of media suspension orders. Isos do not capture all the story. The same period where they went from 65 in 2011 i understand there were a number of voluntary surrenders, as many as 1000 a year. Is that correct . Ms. Ashley yes, sir. Sen. Leahy a voluntary surrender to be a quiet resolution to an investigation. Ms. Ashley it is a resolution and it is a great tool for us. Sen. Leahy for the person surrendering, they have to pay criminal charges, is that correct . Ms. Ashley there would not be criminal charges. It is an administrative action that would immediately stop the registrant ability to handle controlled substances. It is a great tool for us. Sen. Leahy they do not have any penalty or public admonishment . Someone else could step in and do the exact same thing, correct . Ms. Ashley yes, sir, that is correct. Sen. Leahy as a former prosecutor, i think criminal action is a deterrent. If you have 1000 of these with noncriminal action a year, is that really working as much as a deterrent in your estimation . Ms. Ashley it is because one thing we have to keep in mind is we have 1. 7 million dea registrants and the overwhelming majority are doing the right thing. There is a very small percentage that may violate the act and they are a tightknit community as most professionals are and when they are in the same business activity. I believe in my experience, it does create a deterrent effect. Leahy if they are registered with the dea, they are subject to investigation every two years. Have these been affected . Has anybody even highly weighted evaluated these investigations . Ms. Ashley yes, sir. Right now, we have a working committee to basically revamp our scheduled investigations. For the different business activities, there are different periods of time when investigators would conduct those investigations. Sen. Leahy the reason i ask weve asked questions. For example, senator wyden and i sent a letter regarding diversion enforcement. It was in 2016. Especially after there was an article in the Washington Post after there was a coziness after the dea Enforcement Actions because of coziness with the ozone drug distributors. We did not get an answer to the question. Would you look at that 2016 letter and respond to us . Ms. Ashley yes, sir. Senator leahy you said d. E. A. Is working to provide specific guidance regarding the identification, reporting suspicious orders as a year ago. When will we see that guidance . Ms. Ashley sir, we are in the final stages of that and i anticipate it will be spring. And actually in the spring we also have a meeting with stakeholder registrants to have a discussion about it. Senator leahy in that are you being affected at all President Trump saying you will have a regulation you got to get rid of two former regulations . Ms. Ashley certainly we have to be in compliance with, you know, with the acts that are in place, certainly we have to be in compliance with that. But that doesnt prevent us from continuing to draft regulations. Senator leahy ok. Thank you. Mr. Chairman, i think under those circumstances if i was go to be involved with criminal activity, i would love that order one step forward, two steps back. I thank you for your commitment to get that planning to get an answer to that letter and i look forward to it. Ms. Ashley absolutely, sir. Thank you, mr. Chairman. Ms. Ashley, welcome. How long have you been with d. E. A. . Ms. Ashley over 30 years, sir. And youre the act assistant commissioner . Ms. Ashley administrator, yes, sir. Does that mean youre the number two . Ms. Ashley no. Im three down. You are within the top five, huh . Ms. Ashley top nine . Top nine, sir. Ok. What was your position under president obama . Ms. Ashley for a period of time i was the Deputy Assistant administrator and prior to that i was Diversion Program manager in the chicago area. Senator kennedy so you were a senior official . Ms. Ashley yes, sir. Senator kennedy what was your opinion about the effective Drug Enforcement act . Ms. Ashley so if i could clarify, sir, i reported under basically the end of president obamas administration. So by the time i reported all those conversations senator kennedy you were aware of this act . Ms. Ashley yes, sir. Senator kennedy when it was a bill . Ms. Ashley yes, sir. Ms. Ashley senator kennedy were you for it or against it . Ms. Ashley i was concerned about it, sir. Senator kennedy who did you express those concerns . Ms. Ashley internally to my staff. Senator kennedy did you extress your concerns to anybody senior . Ms. Ashley at the time it would have been my immediate boss who is no longer with d. E. A. Senator kennedy did you tell your immediate boss that you had concerns about it . Ms. Ashley yes, sir. But at the time if i could explain we had all just reported. It was a new sweep in management so he was at had just gotten familiar with the bill, too, so he was not part of those conversations. Senator kennedy among the top 10 people at that time when this act was a bill, among the top 10 people at d. E. A. , who opposed this bill . Ms. Ashley sir, i could name names but none of those individuals are currently at d. E. A. Senator kennedy ok, name names . Ms. Ashley the prior Deputy Assistant administrator, mr. Joseph renacci. Senator kennedy opposed it . Ms. Ashley opposed it. His management staff. Senator kennedy id like some names, if you could . Ms. Ashley immediately under him he had a deputy and i would be not precise on their time frames or when they were sitting in that chair but there was a time where he had a Deputy Assistant administrator, alan santos, at the time. Senator kennedy who else . Ms. Ashley the administrator at the time which would have been michelle linhart. Senator kennedy who else opposed it . Ms. Ashley thats all i can think of now. Senator kennedy if you think of others can you write me . Ms. Ashley yes, sir. Senator kennedy who top 10 managers at d. E. A. At the time, who supported it . Ms. Ashley i wasnt present so it would be difficult for me to say who did support it. I didnt have a conversation with anyone that told me they supported the bill. Senator kennedy ok. So nobody did and you were a senior ms. Ashley sir, i am saying i didnt have a conversation. Its not that no one did, im not aware of it is what im saying. Senator kennedy somebody had to. Ms. Ashley i believe youre correct, sir. What im saying, i wouldnt know that. I had conversations with those who didnt. Senator kennedy who would know that . Ms. Ashley im trying to think of someone who is currently at d. E. A. That would have been part of those conversations. Currently our acting administrator was not part of those conversations. Myself. My direct i directly report to the Principal Deputy administrator. He was not part of those conversations. Senator kennedy and i appreciate it. You know were limited on time. Tell me who at d. E. A. Pushed this bill . At the time . Ms. Ashley sir, i dont have a name for you. But i would like to get back with you if i could make those determinations, id like to do that. Senator kennedy heres what it looks like to me, ms. Ashley. I know senator hatch and senator white house and i dont believe whitehouse and i dont believe for a second they would support legislation over d. E. A. s objection that would hurt people. I dont believe they would do that. I think d. E. A. Or somebody at d. E. A. Said this was a good piece of legislation and now all of a sudden we cant find them with a map or a search party. I just want to know who did. And if everybody was so opposed to it at d. E. A. , why werent they raising all manner of hell . Senator grassley when she has a chance to think about answering your question she can answer it in writing for you. Senator kennedy do you want me to shut up now, mr. Chairman . I was on a roll. Senator grassley we will have a second round. Senator kennedy i take that as a yes and apologize for going over. Thank you, ms. Ashley. Senator durbin thank you for being here. It came as a shock to me when there was testimony a couple years ago in this very room by the acting administrator of the Drug Enforcement administration, senator kennedy, i didnt know, the education of a senator is a daunting task. What i learned was there was a federal agency which controlled the amount of opioid pills, the number, the volume each year. They established quotas and they told pharmaceutical Companies Across america, these are how many you can produce. It turns out that for a long period of time the pharmaceutical companies had been demanding more and more and more. I have 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 permission and authority of the agency that you work for. The Drug Enforcement agency came to us and testified that about the terrible Opioid Crisis and then when i pinned them on it i was told they were given the green light for the production of the opioid pills. And pharma, pharma in general, was asking for more and more and more. And i said to the head of d. E. A. , 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 agency 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 in america to have a onemonth prescription. Now, i know there are people with chronic pain and illness who need it, and i will fight for their right to get it. But a oneminute prescription for every one of us in this room and every adult in america, cmon, as they say in one of those sports show. Also, what brings us here today, is a question about distribution. I represent i 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 nine million hydrocodone pills over window years. Population 392, nine million pills. Whos the cop on the beat . Drug enforcement agency. And the question is whether or not we did anything to make your job easier or harder. I watched a 60 minutes segment a couple times, i couldnt agree with senator kennedy more and with my colleagues, i dont know any of us voting for this felt we were making it easier for people to distribute an indefensible level of these drugs but it happened. I guess the question that were basically asking you is now that 44 attorney generals said we made a mistake, did we make a mistake . Should we repeal the ensuring Patient Access and effective Drug Enforcement act to make sure you have more tools and you can get tougher with those who are clearly abusing the production and distribution of these pills . Ms. Ashley thank you for the question, senator. Again, we have tools and we have a bucket of tools and the immediate suspension order is just one of them. We have not been hamstringed in a manner that we cannot continue to do our jobs. We look forward to working with this committee if the committee decides there should be something differently done with the current legislation but well continue to work within those bounds. Dush let me see here. The d. E. A. Senator durbin let me see here. The d. E. A. Issued suspension orders 65 from the year 2011. This was in the early stages of our Opioid Crisis. Five in 2015. Nine in 2016. I think the cops on the beat are not spending time looking for criminals here. If we are truly dealing with an Opioid Epidemic with numbers i just read to you, these suspension orders do not 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 nine 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. Im speaking generically as an agency, not about you personally, and thats what i worry about. Ms. Ashley senator, this is again, this is just one tool. Certainly were using other tools to do our job. And we have a dedicated work force, as im sure i met with you a couple times and had that discussion about quota. Yes, it did rise over several years under prior management at the time. It was deputy administrator joseph renacci. As quota is determined by our statute, i dont know what what he had in front of him to make those determinations. Im sure they were very careful determinations. When i met with you, sir, we had discussions and we went back to the table. I met with you and also our previous administrator chuck rosenburg. We went back to the table. We had discussions and we have lowered it. The first year senator durbin ill just close, mr. Chairman. We are not dealing with a runaway virus here. We are 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 and distribution by doctors and pharmacies and others and our failure to respond adequately. Thats why were sitting here today. Senator grassley senator cruz. Senator cruz thank you, mr. Chairman. Ms. Ashley, thank you for being here and testifying. I want to follow up on some of the questions that senator kennedy asked you. Youre here testifying on behalf of d. E. A. Did the d. E. A. As an agency take a position when this legislation was pending before congress . Ms. Ashley again, i hate repeating myself. I was not present during those conversations but it was my knowledge that concern was expressed the entire time. Senator cruz ok, your personal knowledge youre testifying on behalf of an agency. Ms. Ashley yes, sir. Senator cruz presumably somebody at the d. E. A. Knows whether the d. E. A. Took a position on this piece of legislation. Ms. Ashley yes, sir. Senator cruz the agency as a whole knows. Ms. Ashley yes, sir. Senator cruz how would that position have been expressed . Ms. Ashley i believe it was expressed and discussed in discussions through the department and to initially working with the house and also with the Senate Judiciary committees. Senator cruz did the department of justice express a position on this legislation . Ms. Ashley i believe that, yes, sir. Senator cruz did they support this legislation . Ms. Ashley in the end they support the ultimate language. I believe the concern of how the bill would affect how we conduct our investigations was expressed throughout. Senator cruz i just want to understand. So the department of justice supported the legislation in the version that actually passed, is that correct . Ms. Ashley yes, sir. Senator cruz and the d. E. A. Supported the legislation in the version that actually passed . Ms. Ashley yes, sir. Senator cruz what advice did the d. E. A. And the department of justice give president obama on whether to sign this legislation . Ms. Ashley that conversation would have been through the department of justice. Im not certain what it was but i know that Technical Assistance was provided in the final language. Senator cruz all right. So is the legislation working . Set aside whether d. E. A. And d. O. J. And the entire u. S. Executive branch was supporting the legislation, set that aside. We are a year into it. Is it working or unintended consequences . Ms. Ashley we were able to continue to issue i. S. O. s, as we have in the past. It didnt hamstring us from doing that. The concern was manufacturers and distributors, 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. Senator cruz you havent executed one . Is that a problem, a lack of legal authority, why havent you . What are we missing . Ms. Ashley actually, sir, the distributors 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 distributors, their close enough knit community to turn effect kicks in. The larger distributors, the big three, we call them, they had recent action taken against them. Since the implementation of the i. S. O. , theyre already under memorandum of agreement to be in compliance with the controled substance act. It hasnt been warranted so far. Senator cruz there hasnt been a factual predicate or need for it . Ms. Ashley there hasnt been a test case. Senator cruz what is not working about this legislation, if anything . 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. Ms. Ashley so the concern now prior to the legislation we were in a preventative mode. We want to stop this distributor from making shipments before there is harm done. We could identify violations of the controlled substance act solely that the distributor committed. The current legislation requires that we establish a substantial likelihood of immediate deaths, bodily harm and abuse. Prior to that we would only need to establish the potential increase potential for diversion. Senator cruz does the d. E. A. Believe this legislation needs to change . Ms. Ashley d. E. A. , along with the department of justice, supports a change in the legislation, yes. Senator cruz what change does the d. E. A. Support . Ms. Ashley so theres where i have to be careful. I am 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. Senator cruz im going to ask you if the d. E. A. As an agency has a position supporting a change in legislation, i would ask you convey that to me and im sure my colleagues would be interested in writing . Ms. Ashley yes, sir. Senator cruz the specific language that you believe would work better. Ms. Ashley yes, sir. Senator cruz we cant understand what youre requesting if the agency doesnt request it clearly and with language attached. Ms. Ashley yes, sir. I will do that. Senator cruz thank you, ms. Ashley. Senator grassley senator whitehouse. Senator whitehouse yes. To followup on senator cruzs point, we had these conversations with d. E. A. When this bill was being developed and we reached an agreement that d. E. A. Signed off on, that was approved by the administrator, that was approved by the attorney general of the United States and on the recommendation of the 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 which the executive branch in the form of h. H. S. Which is to be advised by you all at d. E. A. 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 d. E. A. Signed off on the bill as it is. D. E. A. Has no proposal to change it, and h. H. S. Refuses to do the report that congress commanded. That doesnt give us a great position. So i hope 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 im not missing. One is letters of admonition. You can do letters of admonition more or less, correct . Ms. Ashley yes, sir. Senator whitehouse and the second you can call administrative hearings and you can drag a distributor in for their conduct . Ms. Ashley yes. Those rin formal hearings. Senator whitehouse and require a letter of memorandum to be entered as a resolution of a dispute with d. E. A. , correct . Ms. Ashley that is correct, sir. Senator whitehouse and voluntary surrender of the license so they can give up and cash in and go away . Ms. Ashley yes, sir. Senator whitehouse 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 . Ms. Ashley yes, sir. Senator whitehouse and that puts immense pressure on them, even the threat of that, to come into compliance . Ms. Ashley yes, sir. Senator whitehouse and the ability to push for that order to show cause is unilateral on your part . Ms. Ashley providing evidence, yes, sir. Senator whitehouse and you can bring Civil Penalties, civil action, you can take d. O. J. Lawyers and go into court against them . Ms. Ashley yes, sir. Senator whitehouse in 2017 you hit a record, 494 million in Civil Penalties against distributors, correct . I am not going to hold you to that Civil Penalties has been an effective and enforcement technique against diversion . Ms. Ashley yes, sir. Senator whitehouse and finally criminal actions. You make about 1,500 diversion cases a year in criminal courts in which you have the requisite intent to show and somebody actually is sanctioned, goes to jail, gets a criminal fine levied for them against that . Ms. Ashley yes, sir. Senator whitehouse 15 per year . Ms. Ashley more or less. Senator whitehouse the last time was back in 2012, correct . Ms. Ashley yes, sir. Senator whitehouse and lets just say youre hesitant in 2015, the agency, the bill coming up in 2016, so lets go back to two whole years, 2014. You only did eight i. S. O. s in that whole year compared to 1,500 criminal cases. Correct . Ms. Ashley yes, sir. Senator whitehouse so doesnt sound like its the centerpiece of your enforcement bucket of tools. Ms. Ashley sir, if i could if i could say that most of the i. S. O. s and also orders that show cause on physicians and pharmacies, historically they have been used very sparingly on distributors and manufacturers. Senator whitehouse there should be good reason for that because usually distributors lets focus on distributors because thats the focus of this legislation. Usually distributors arent a factor, really, in the direct diversion of pills unless you find they have lost control of their inventory and are slipping stuff out to the public, what theyre doing, mostly in these cases, as i understand it, is failing to report to d. E. A. Where drugs are going in inexplicable numbers. I mean, how often do you see a diversion case where the opioid pills are directly leaving a distributor into the hands of the illicit user . Ms. Ashley it doesnt, sir. But what happens is the distributor is responsible to senator whitehouse correct. Ms. Ashley Due Diligence. Senator whitehouse its a reporting and Due Diligence requirement, not a dwrect diversion issue, correct . Ms. Ashley yes, sir, it leads to. Potential. Senator whitehouse absolutely. On the part of the pharmacy, on the part of the pill mill, on the part of everything happening downstream where the opioid pill goes to the illicit user . Ms. Ashley right. Senator whitehouse you have recommendations. Were eager to hear them. I will conclude by saying its incredibly frustrating to have the agency that signed off on this and supported it all the 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, h. H. S. , 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. Ms. Ashley thank you, sir. Senator whitehouse thank you for your service. Senator grassley if they refuse to do it as 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 ought to make a report they ought to make the report. Senator whitehouse and the law has a date in it. Senator grassley are you saying theyre actually never going to do the report . Senator whitehouse i have no idea. They are eight or 10 months late and theres no sign of it on the horizon. It would be great if it was done timely but i think whats important is that we have the report that the law commands. Senator grassley senator klobuchar. Senator whitehouse it would be nice to have it in the time frame the law command. Senator klobuchar thank you. Ms. Ashley, i have long worked on these issues, including passing one of the drug takeback laws with senator cornyn and thats why i am so disheartened whats been happening. I am a cosponsor of the bill to repeal the 2016 ensuring Patient Access and effective Drug Enforcement act. And i guess start with this. Do you have reason to believe that the d. E. A. Would have issued more i. S. O. s had the law not been enacted . Ms. Ashley its difficult to answer, senator. I dont believe so. And the reason i dont believe so is because when we conduct investigations we just take them where the evidence takes us. So thats senator klobuchar there would happen to be a dropoff of these while the Opioid Crisis was growing . Ms. Ashley for immediate suspension orders, if youre speaking specifically about distributors, they have always been used very sparingly. Its almost a unique thing. Senator klobuchar so lets go back at the numbers. I understand that between fiscal years 2009 and 2012, the d. E. A. Issued an average of more than 40 immediate suspension orders a years. These orders enabled the d. E. A. To stop these suspicious shipments. However, since fiscal year 2014, the d. E. A. Has averaged only seven i. S. O. s a year, is that right . Ms. Ashley in 2014 senator klobuchar since 2014. Ms. Ashley since 2014, yes. Senator klobuchar ok. And i understand that there has not been an i. S. O. Issued for a distributor or manufacturer of opioid medication since 2012. Is there a reason why only pharmacies and practitioners have been the subject of the most recent i. S. O. s . Ms. Ashley i can explain that when investigators engaged with distributors and manufacturers, specifically, because we have the responsibility to make sure that patients have access, we want to keep them in business. We want to bring them in compliance. Its only the most egregious that we would ever use an order an immediate suspension order for. Senator klobuchar so there were no distributors since 2012 that the agency felt they should go after . Ms. Ashley we have engaged but we may have used a different tool as senator whitehouse mentioned, there are so many other things we can use to bring them into compliance. Senator klobuchar i understand that in addition to the immediate suspension order, as senator whitehouse smentionmenksed, the d. E. A. Has different authorities. Can you elaborate on the immediate suspension order and d. E. A. s enforcement efforts . Ms. Ashley so the immediate suspension order is a tool that d. E. A. Would use when were on site, reveal information that theres something really egregious going on. Egregious in the sense we would need to stop its not in the Public Interest for to you have a registration and this needs to cease immediately. Its almost a cease and desist. Theres still a prosest drafted. Theres still an opportunity for cease immediately. Its almost a cease and desist. Theres still a prosest drafted. Theres still an opportunity for a hearing. Theres still negotiations and conversations with our with the prosecutors and defense attorneys. Sos still a process. It doesnt happen immediately, as the word says, but its always been used sparingly. Senator klobuchar although much attention is focused on the changes to the 2016 law, certainly at this hearing, im also interested on hearing your views on another provision of the law that allows Drug Companies for an opportunity to submit correction action plans to the d. E. A. Prior to having their license revoked. What is the d. E. A. s position . Ms. Ashley its redundant and unnecessary and the reason is, when we engage with region registrants, were having those conversations. The opportunity for remedy have already occurred. We always try to bring a registrant into compliance. We have that conversation. Sometimes for several months. So by the time we get to the point were issuing an order to show cause and a correction action plan we already had the conversation so thats why its unnecessary. Senator klobuchar i understand the d. E. A. Issued 194 million in Civil Penalties in 2017. Thats more than the Civil Penalties in the past seven years combined. Can you lastly tell me about this recent increase and why the d. E. A. Has been pursuing more Civil Penalties . Ms. Ashley actually, senator, that wasnt more registrants. One registrant paid a fine of 150 million. The second one paid an additional fine. Senator klobuchar do you think there are others out there that should be paying that kind of money . Ms. Ashley if it warrants it, yes. If investigators are on site and disclosing evidence that supports it, absolutely. Senator klobuchar it just seems odd that there is one that would account for so much of it and there are others out there. Ms. Ashley there are three distributors that basically supply most of the market when account for so much of it and it for opioid drugs. Senator klobuchar what are the other two . Ms. Ashley the other two are other cases against them in other types of actions. Senator klobuchar are those pending right now . Ms. Ashley one of them is. One is not. Senator klobuchar ok. Senator grassley senator blumenthal. Blumeblume thank you, mr. Chairman mr. Blum senator blumenthal thank you, mr. Chairman. A lot comes down to unintended consequences of this law and one of the chief unintended consequences seems to involve the term substantial likelihood. Would you agree . Ms. Ashley yes. Also the word immediate and also death, bodily harm. Senator blumenthal i was going to come to those issues as well. Ms. Ashley sorry. Senator blumenthal thank you for pointing it out. Under the law we are discussing today, the d. E. A. Can shut down drug shipments immediately whenever it concludes there is a, quoteunquote, substantial likelihood. Failure to do so will result in some harm, including the harm of illegal drug abuse or other kinds of harms. I wonder if you could give us an idea of how the d. E. A. Defines the term substantial likelihood and also some examples of situations where the d. E. A. Would want to shut down drug shipments but it does not believe that there is a substantial likelihood. Some realworld experience as to what the definition of the term is and how it has in effect diminished your ability to stop these shipments. Ms. Ashley so the mission of a 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 is take away the prevention piece of it. So what we would want to do with an immediate suspension order is to stop the shipments, take away the d. E. A. Registration so no further shipments can go. Therefore, preventing harm. Senator blumenthal it just changed the standard, yes . Ms. Ashley yes. Senator blumenthal you just to have meet a different standard. My question to you is how, in practical terms give me some examples. You faced a situation where ms. Ashley i faced a situation where a distributor willfully, with great knowledge, avoiding the controlled substances act, not reporting suspicious orders, not exercising Due Diligence, constructing structuring shipments so they can remain under d. E. A. s radar. For that those would be grounds alone solely to do immediate suspension order. With the new legislation, i would need to go upstream from the harm and thats a death or bodily harm or abuse. I would need to work backwards. Senator blumenthal and show a substantial likelihood of harm . Ms. Ashley yes. Senator blumenthal you would have to show some likelihood before . Ms. Ashley we were aiming to prevent diversion because its foreseeable if drugs are diverted and they get to someone who should not have them, its foreseeable there will be harm. So we always use the tool as a preventive method. Senator blumenthal are those shippers who are stopped likely to have had violations previously . Ms. Ashley likely, its possible, yes, sir. Senator blumenthal my guess is that the distributors who would be shut down were repeat offenders, correct . Ms. Ashley in most cases theres an elevation, yes, sir. Senator blumen in all so wouldnt be senator blumenthal so wouldnt you be able to show harm previously resulting from their violation in this law . Ms. Ashley this law ultimately, yes, and we will. This is a law of the land. So d. E. A. Is going to continue to work within what we have. We will continue to use resources. If thats whats necessary, absolutely we will do it. What we would like to do is continue using the legislation continue using the legislation using legislation as it previously was to prevent. Senator blumenthal you want to gack to the legislation that existed previously with the lower bar or standard . Continue using the legislation using legislation as it previously was to prevent. Senator blumenthal you want to gack to the legislation that existed previously with the lower bar or standard . Ms. Ashley with the standard in which we can prevent diversion. Senator blumenthal let me ask you in the short time i have remaining, should congress be providing more funding for this kind of effort . Isnt that as big an obstacle to you in terms of diversion, control, and prevention as you rightly highlighted as this Legal Standard is and change in Legal Standards . Ms. Ashley additional resources, sir, additional tools is always a great thing to support Law Enforcement. I appreciate that. Senator blumenthal if congress could do one thing to crack down on illegal diversion, what would you recommend, more funding or change in this law . Ms. Ashley thats a tough question. Senator blumenthal if its a tough question, i gather ms. Ashley because i like both. Senator blumenthal funding is as important as the change in this law . Ms. Ashley it is, yes, sir. Senator blumenthal thank you, mr. Chairman. Senator hirono if you need to change this law we need to know what specific changes to make and in addition, mr. Chairman, if you could go after h. H. S. For producing the report that theyre to have produced. As weve been focusing on the number of i. S. O. s and that number seems to be decreasing as weve been focusing on the number of i. S. O. s and that number seems to be decreasing but you testified there are other tools such as criminal actions, etc. , so has there been a dramatic increase in d. E. A. s use of these other tools over a course of time . That you can provide to us . Ms. Ashley dramatic increase. Senator hirono you say i. S. O. s are going down and there are that you can provide to us . Other tools. 1,500 criminal cases, i dont know, compared to when . Ms. Ashley what we do is expand and grow in strategies and techniques. There are several of them i would need to i would actually need to get back with you to really demonstrate it because there are so many of them that i can tell you, yeah, we have more l. O. A. s, more m. O. A. s. Senator hirono you may not have the percentage of the increase of these tools, but is it your sense d. E. A. Has increased the use of these other tools because we have an ongoing and growing Opioid Crisis . Ms. Ashley yes. Senator hirono please provide us with some information along those lines. Im interested in this chart, though, that was provided to us by senator durbin. Thats this chart that he had. It looks as though there is a decreased number of requests from manufacturers for drug per increase in drug production. Would you say this is a temporary is this just a temporary decrease . Because up to 2017 there was a pretty high approval rate. Whats going on here that leads to this lower drug production in 2017 and 2018 . Ms. Ashley senator, we are bound by statute. When we develop the aggregate production quota, and every year we start over fresh. We make that determination based on the facts we have before us, what the United States needs, medical and scientific need, and all types of factors, inventory and that sort of thing. We met with senator durbin, actually, a couple of times and had these conversations with some other senators present. In making those analysis we determined, for the 2017 a. P. Q. , that it was possible to reduce it. And that was that was actually an easy which because there was a cushion put on for emergencies early. For the 2018 aggregate production quota we were able to reduce it again. Thats, again, looking whats required by statute and doing some critical analysis on whats necessary. And well do the same thing again for the 2019 aggregate production quota. Senator hirono thats good. Thats going in the right direction. As senator durbin indicated, its hard to believe that our country needs 14 billion opioid pills per year. I really dont know how you go about determining what the country needs, but the fact that were in a crisis and that the approvals are going down, thats a good thing. I want to ask you about your 360 strategy for attacking the Opioid Crisis. Hawaii has been relatively low key in we have been spared the worse of the Opioid Crisis but just recently the state released an Opioid Initiative action plan that includes a focus on six areas. Treatment, access, prescriber education, data informed decisionmaking, prevention and public education, pharmacybased intervention and supporting Law Enforcement and first responders. So with your it sounds sort of like your 360 strategy in which you were in a number of states. Based on your experience with your 360 strategy, what are the most effective ways for states or in fact cities to combat the Opioid Epidemic . And i listed six things that hawaii has come up with. Ms. Ashley so the most important thing that our agency has been very focused on is engagement and enforcement. Its going to be necessary, especially when it comes to those who handle our registrants, those who legitimately handle controlled substance. Continue our engagement. Getting out to everyone who is listening to the community, to the public, to our registrants and also enforcement, and thats making partnerships. Senator hirono ive gone over time. I wanted to ask in hawaii, have you worked with people in hawaii . Ms. Ashley yes, i have. Senator hirono thank you. Senator grassley we had two members, senator kennedy and senator hatch, for a second round. I hope we can limit it to the five minutes for each of yall. Ill start with senator hatch. Because we have a second panel we got to get to and give them time, too. Senator hatch well, thank you, mr. Chairman. Id like to start this second round by raising an issue of concern. Its come to my attention recently that theres a move by travelers to make pharma the next big tobacco. Trial lawyers are organizing conferences across the country to discuss plans to bring multistate class actions against drug manufacturers and distributors and turn them into villains. One recent article about this effort quoted one of the leaders of this effort as saying, quote, the vilification of this industry has not even begun yet. This litigation will vilify them. They wont make the Companies Look like legitimate business people. It will make them look like they took advantage and made billions of dollars on lots of people who died from their products, unquote. Its my understanding, mr. Chairman, that some of the most vocal opponents of the legislation were discussing today, some of the loudest are paid consultants to these trial lawyers suing the drug industry. That doesnt mean we shouldnt discuss their views. What i dont want to have happened is for this committee to become a vehicle for travelers pursuing a carefully mapped out strategy. I understand they intend to get states attorney generals involved which is the letter we received from the National Association of state attorneys general. So lets be cognizant of some of the other things going on here. Now to my questions. I have here another chart right here. This shows d. E. A. Show cause orders over the last nine years. That was as far back as i could get the data. Again, the vertical dotted line on that chart indicates when the ensuring Patient Access act passed. I want to make two quick points. First, the data shows show cause orders actually increased after the act passed by nearly 40 . Second, d. E. A. Has issued more show cause orders this year than at anytime in the last nine years. Simply put, the ensuring Patient Access act has not caused any sort of slowdown in show cause orders. Now, the ensuring Patient Access act provided a definition for imminent danger where one didnt previously exist. Let me ask you, why is it a problem for d. E. A. To have to meet a publicly known, clearly defined standard when issuing an i. S. O. . Isnt it appropriate for individuals and companies to know the standards theyre being held to . Ms. Ashley senator, the new legislation in one manner doesnt apply to the matter for show cause. It only applies tore the immediate suspension orders. As far as the orders for show cause goes, thats the corrective action plan where registrants are able to come back to d. E. A. And, you know, explain what their remedy is or the changes they made to the violations that were disclosed. Senator hatch in a house hearing, the head of diversion control operations at d. E. A. Was asked whether he agreed if congress repealed the ensuring Patient Access act and, quote, didnt supplement it with something else, then the same vagueness that raised concern from the whole host of constituencies would come to bear once again, unquote. Now, mr. Dougherty replied, yes, sir. I believe we need a mechanism at that level with respect to that tool, unquote. Now, do you agree with mr. Dougherty that simply repealing the ensuring Patient Access act and not having in place any sort of definition for imminent danger, as some advocated, is not a viable course of action . Ms. Ashley senator, in our collaboration and d. E. A. s collaboration with d. O. J. , we believe that a change should be made. What that looks like in the end, its going to require additional additional conversations, sir. Senator hatch ok. Chairman grassley invited d. E. A. Chief Administrative Law judge mulrony to testify at this hearing. As we know judge mulrony has written an article sharply critical of the ensuring Patient Access act, and this article has formed the basis of much of the criticism in the law. Its my understanding that the agency declined to allow judge mulrony to testify because, quote, Administrative Law judges are neutral finders of act and of fact, and Administrative Law judge is not in a position to testify in his official or personal capacity nor to comment on legislation, unquote. My question is, how do you square this position with the fact judge mulrony has already commented very publicly on this legislation and is being quoted extensively in the media by virtue of his position within the agency . If an Administrative Law judge is not in a position to comment on legislation, why is he in a position to write a law review article excoriating a law that he himself is tasked with adjudicating . These are questions i think are legitimate questions. Did d. E. A. Authorize judge mulrony to publish this article . Ms. Ashley senator, i am not aware of that. I can tell you d. E. A. Has publication review board. Im not aware if judge mulronys publication senator hatch what was d. E. A. s reaction when they saw the article, do you know . Ms. Ashley as a whole, sir, i dont know. Senator hatch is it common practice for judges to publicly apply on merits of laws that they are tasked with adjudicating, why or why not . Ms. Ashley sir, it may be, but we have a process in our agency where it would be presented before the publication review board. Once that approval is met, then it can happen. Senator hatch ok. Mr. Chairman, now before closing, mr. Chairman, i ask unanimous consent to enter several documents into the record. 2014 pharmacist survey. Two g. A. O. Reports. An oped by representative marino describing the origins of the bill. Some news reports about Patient Access problems. The letter from the v. C. U. Professor describing troubling conduct by d. E. A. Diversion control agents. And paper copies of these two charts. I also ask unanimous consent to enter into the record two letters from Patient Advocacy groups explaining the need for this law, the second of which was signed by 31 organizations. Senator grassley without objection, so ordered. Senator kennedy. Senator kennedy ms. Ashley, i want to thank you for coming today. Ms. Ashley thank you, sir. Senator kennedy youre a brave american. You ought to ask whoever made you come for a pay raise. Who else is here with you today from the d. E. A. . Could you just raise your hand . Who else is here from the Justice Department who works with d. E. A. . Ok. Welcome to all of you. This example cited by senator durbin, ms. Ashley, from kermit, West Virginia, nine million hydrocodone pills over two years sent to a single pharmacy in a town of 392 people. Were you familiar with that . Ms. Ashley yes, i am, sir. Senator kennedy just breathtaking. The American People are watching this. Let me tell you what theyre thinking, in my opinion. They dont care about the meaning of the word immediately meaning of the word immediately or imminent danger, or theyre not interested in the i. C. O. Or the d. E. A. Or the c. S. A. Or the nba or the nfl. What they want to know is how a federal agency or agencies allowed nine million hydrocodone pills over two years to be sent to a single pharmacy, not five, not four, not three, but one pharmacy in a town of 392 people. Thats 23,000 pills per person. Thats 31 pills a day for every man, woman and child in kermit, West Virginia. How could you allow that to happen . You know what the people of america are thinking . They dont care how many lawyers can dance on the head of a pen. They want to know how were allowing this to happen. Theyre asking, what planet did we all parachute in from . How could the d. E. A. Let this happen . You talked about all the tools you had. Were they not sharp . How could this happen . Go ahead. Ms. Ashley sir, i hear you and i share i truly share your sentiment and so do the men and women of d. E. A. I have here with me today my son. Hes a senior in college, and i hold him very close. Sitting right here senator kennedy whats his name . Ms. Ashley his name is omari. Senator kennedy omari, welcome. Ms. Ashley when we read the news reports of the individuals who are being harmed the most, its that age group, between 18 and 24. It breaks my heart. Senator kennedy ms. Ashley, i agree with you. How does this happen . Ms. Ashley i can tell you we have processes, and since i had to bet with my staff, we have worked very hard to change those processes. Could we do some things better . Absolutely. Senator kennedy we have to work harder. Ms. Ashley yes, sir. Senator kennedy this is insanity. I heard senator hirono say there are 14 billion pills distributed in the United States every year. There are 323 million americans. Thats 43 pills for every man, woman, and child in america. Ms. Ashley yes, sir, and i agree with you. We have to do we have to do we have to do everything possible. We have to do what were doing today, having these conversations and developing different laws and tools that can help the d. E. A. And all of Law Enforcement. Senator kennedy i mean no disrespect. I meant what i said. I am so pleased you would come today, but i dont want to keep having conversations. Id like you to have whoever makes decisions at d. E. A. And justice to send me a letter and say, this is what we need to do to stop someone from sending nine million hydrocodone pills over a twoyear period to a single pharmacy in a town of 392 people. Ms. Ashley yes, sir. I am happy to do that. Yes, sir. Senator grassley send a copy of that letter to me too, please. Sen. Hatch i wouldnt mind having one too. Senator grassley ms. Ashley, were at least for now, were done with you. And youve been very brave coming here. And we know that a lot of things that arent in your hands youve tried to answer because you are the witness. Youll also maybe receive some questions in writing from us or people that arent here today. So they should be received in at least a week and then answer as soon as you can if you do get questions in writing. We thank you very much. Ms. Ashley yes, sir. Thanks, senators, for your time today. Senator grassley now, will the next panel come, please . While the next panels coming, im going to introduce the next panel even though you arent seated. Our first witness is jan chambers, president of the National Fibromyalgia and chronic pain association. A not for profit organization. Mission is to execute advocacy programs regarding access to care, scientific research, diagnosis and treatment for people suffering from those diseases and chronic pain. Our second witness on our panel is attorney general brian frosh. He has served as the attorney general for the state of maryland since 2015. The maryland since 2015. Through his position at attorney general for maryland, mr. Frosh represents the interest of the state of maryland in cases involving community safety, environment damage, consumer fraud, predatory Business Practices and civil rights issues. Prior to his position as marylands attorney general, he served in the maryland General Assembly for 28 years while also working as an attorney in private practice. He served five terms in the Maryland State Senate and four terms in iowa in maryland house of representatives. Or house of delegates. Next we have dr. Carmen catizone. Dr. Catizone is the executive director of the National Association of boards of pharmacy and secretaries of the associations executive committee. In this capacity, he is responsible for the oversight of the National Association of boards of pharmacys delivering quality of programs, products and Services Offered by that association. Hes also responsible for assisting the executive committee of the nabp, fulfill its governance functions and hes also a registered pharmacist. And last witness john m. Gray, president and c. E. O. Of Health Care Distribution alliance and has held these positions since 2004. Hes responsible for overseeing all operations of the Health Care Distribution alliance which is an organization that represents primary pharmaceutical distributors. Well start with you, ms. Chambers, and go the way i introduced from my left to right. Ms. Chambers all right. Thank you, sir. Thank you, chairman grassley, senator feinstein, senator hatch, for allowing me as a patient representative to come and testify today and to the distinguished members of the committee and thank you for having this hearing. In december, 2005, my world changed after hysterectomy surgery. Electrifying shocking pain went through my body and i hurt everywhere, curled up on the couch and disabled for 16 months. Headaches developed. Nobody could touch me because of so much pain and i had seven or eight pillows to support my legs and arms from touching each other. Not sleeping, waiting for the days pass. Cannot think about anything but not moving and praying the pains. I typed a twopage list of health problems. Psychologists and doctors told me nobody can have that many things wrong with them. It would take up too much appointment time. We spent tens of thousands of dollars on doctors and tests. My family became my caregivers. I felt like a burden to my family, and understood stigmatized and misunderstood by the medical community. Every day got more painful. I kept thinking about he cannot experience that money pains. My youngest daughter was 12 and i did not feel it was fair to leave her alone. I thought about my husband, if i take my life he does not deserve diagnosedlly i was with fibromyalgia. And thyroid cancer. I was fortunate to find help. Malesoliferation of pale mills, and pharmacists who filled prescriptions. Turninges again legitimate patients away, asking for cash and getting partial pills. Patient organizations again hearing about distributors and pharmacies and prescribers being unsure why they were being investigated by the dea. Shutdowns of pharmacies and doctors offices were happening. Patients were scared. The dea was Holding Meetings with prescribers to one them about red flags and overprescribing. Doctors reported the red flags were not clearly defined. At meetings, doctors told me they were nervous to treat patients for chronic pain because they did not know who would be lying to get a prescription for opioids. Defensive to being protect their livelihoods, and families are fearful of them making a mistake and going to jail. The general response was to stop treating people with chronic pain. Insurance companies are squarely to share the blame for the skyrocketing use of prescription opioids rather than nonpharmacological treatments. Paying for a generic opioid is simply cheaper than paying for health treatments. They caused harm to patients by increasing symptoms of chronic pain. Doctors point to the ruined reputations of colleagues under dea investigations. Two doctors under investigation asked me to help to find other doctors. I never could. These recommendations not laws nor statutes state legislatures are implementing them as if they are hard fast practice rules. This is harming people who need higher doses of prescription opioids for legitimate reasons that are documented the patient, where this decisions should be made, not at the pharmacy window nor insurance managers. The strategy was quietly published by hhs on the following friday in march. This left little doubt in the minds of millions of patients at how much they do not matter to federal officials. Recently in my office five all ofre doctors them said if she was seeking care for pain they were not taking new patients. She found a lump in her breast, she had a double mastectomy which metastasized to her lymph nodes. Dea investigations caused a Chilling Effect on doctors willing to treat chronic pain patients. Affected inre was october of 2014. At the end of the fda hearing, 12 of the 29 anil members said they were concerned about the impact to chronic pain patients. After several months past with no action by the federal government, our Nonprofit Organization sponsored a survey included in my written testimony. Sen. Grassley thank you very much. Im happy to be here and testimony. Last month 43 of my colleagues and i sent a letter to leaders of Congress Regarding the insuring Patient Access and truck enforcement act. I will refer to as the act. Step backwarden a and our collective efforts to prevent the unlawful distribution and diversion of opioids that have chevy did to our national epidemic. Vital federal partner for all of the attorneys general across the country. It needs a complete set of tools to be effective. Difficult toore stop dangerous and illegal shipments of narcotics. The act also gives additional protection to those suspected of illegal activity. It requires the dea to evaluate corrective action plans instead of moving swiftly to suspend or revoke registration of bad actors. The consequences of the epidemic part,e has been noted in in 2016, more than 2 million americans were suffering from addiction to opioids. Since 2000, about 200,000 americans have died from overdoses of prescription opioids. Another 100,000 from other illicit drugs like heroin and fentanyl. It keeps getting worse. In 2017 we are projected to reach 70,000 deaths. That is more deaths then americans killed during the entire vietnam war, just this year. Despiteemic rages on clear evidence that prescription distribution and manufacture of opioids in excess of medical needs is good to getting to its severity. The letter from state attorneys general put it last month as deaows, the act strips the of a critical tool, the ability to issue an immediate suspension order against a drug manufacturer or distributor whose unlawful conduct poses an imminent danger to Public Health or safety. Under the controlled substances act, the dea has authority where there is an imminent danger to Public Health or safety. The act altered the standard definition by requiring a substantial likelihood of an immediate threat of death, seriousali harm bodily harm. This has eviscerated the deas ability to act, trying it so narrowly, that in the words of George Mulrooney who has been cited this morning, it is now all that logically impossible for the dea to suspend a distributor for failing to comply with the law. Constrainso further the deas effectiveness by giving manufacturers and distributors a new opportunity to avoid sanctions for engaging in unlawful diversion. The new law allows a registrant to file a corrective action plan prior to show cause proceeding, the dea is required to give the manufacturer or distributor 30 days to prepare a corrective action plan. Then to consider in determining whether enforcement proceedings should continue. Leverages lawbreakers to obtain additional chances. As judge mulrooney points out, it is akin to mandating that Law Enforcement authorities allow shoplifting suspects caught in the act the opportunity to outline how they intend to replace the purloined items on store shelves. I remain mindful of the imperative in fighting this crisis we must be careful not to over correct. We must not impede Patient Access to Prescription Drugs that serve immediately legitimate medical needs, but my colleagues and i believe the act from last year does not address this important goal. It just diminishes deas ability to prevent lawful opioid diversion. Face a Public Health emergency. In countries success defeating this threat depends on all of us, state, local, federal authorities working together effectively. We are fighting a Public Health conflagration of Epic Proportions and i believe last years act stands on the firehose. I urge you to repeal it. Thank you very much. Atizone. Ssley now dr. C dr. Catizone thank you. I would like to modify my comments this morning and address some issues that Committee Members have raised. We said our concerns back in september, 2014. In those letters we commented that the law would have a detrimental impact on the protection of Public Health and do it record damage to the enforcement ability of the Drug Enforcement administration. To act decisively when imminent danger to the Public Health and safety exists, it is critical to protect Public Health. It is enforcement action legislatively mandated the and utilized repeatedly and effectively at the state towards pharmacy. The defining of imminent danger to the Public Health or safety law isepa, the ea or the concerning for the perspective of state regulatory agencies that successfully utilize these provisions as formally defined in the controlled substance act tactless expediency and in the foremost protection. Theegard to the data which committee has supplied, in terms of actions taken against wholesale distributors, the immediate suspension orders and the fact there were no orders from 2012 forward, and there was only a small percentage of orders taken against the distributor industry. From a regulatory perspective begs the question, where was the problem . Where was the regulatory problem that mandated that the definition be changed, and or problems with access to pharmacists, pharmacies and patience . Concerns, and we saw what some of those problems were. It did not appear to be the definition of imminent danger that were contained in the original substance act and amended by the new act. As an Expert Witness for the dea and u. S. Attorney, offices across the state, i can personally attest that cases i assisted with were egregious activities i wholesale distributors, pharmacists, and prescribers that threaten public and were ultimately responsible for the deaths of patients. In those cases, the access to controlled substances for legitimate medical purposes and legitimate patients were not issues, and would not have interrupted by the changes that were proposed and enacted by the act. Fortunately, these cases we have come to better understand the wholesale distributor industry. Our collaborative efforts with the states, and a significant number of wholesale distributors have become accredited to allow us to company represent those wholesale distributors who achieve accreditation have processes in place to comply with controlled substances act and regulations. An additional consequence of the enactment of the law, once again in the case i have been involved with as an Expert Witness, there was no question as to what constituted a suspicious order. Requireards, many which suspicious orders convey to any dp that the reporting of suspicious orders to them is an obfuscation of information and attempts to bury them in meeting this paperwork. Situations reported, the reporting entity makes no effort to distinguish a legitimate suspicious order. The reporting seems to be nothing more than saying we complied with suspicious orders by reporting anything and everything. Now you can figure it out. An adp believes this is one area that needs to be by a change in the law. Appreciate the opportunity to appear for the hearing today. We offer our assistance to the committee and urge the repeal of the ensuring Patient Access. Specific length was changes we correctiveare the and changing back to the original definition and the controlled substance act only and utilized for years and years. Thank you. Mr. Gray. Ley good morning chairman grassley, Ranking Member feinstein. Thank you for asking me here today. The final link, between manufacturers, pharmacies, and health care providers. Our industrys mission is to we deliver all types of medicines for chronic disease and more to licensed Healthcare Professionals for their patients. Distribute his work closely with of thechain partners, distributors do not manufacture, we do not prescribe, dispense, or drive demand for these medicines. Hda agree with the president s opiate commission. It requires the collaboration of all stakeholders. Hda is part of the solution to the crisis. For many years, those regulated by dea were challenged by a lack of communication and information sharing by the dea which i have lived through in my entire term. Over the past 11 years, dea repeatedly evolved even though the regulation has not changed since 1973. Over the same. , dea revised substances act, required distributors have effective controls against diversion. Members areear, our committed to working with dea and they happened to address the Opioid Epidemic. Hda does not wish to undermine the deas authority or to private of its enforcement tools. Our members work to comply with the expectations to adjust to the challenges that it company the Opioid Epidemic. Cap an ease heavily in i. D. Systems to flag suspicious patterns. Hda has also repeatedly asked the dea to clarify its expert haitians by publishing guidelines or regulations to develop an effective strategy. The entire supply chain must understand where the agency is coming from. The gao as you mentioned found a lack of communication between , was hampering efforts to combat the diversion problem. Acting administrator told this committee that in his view, the agency had been slow and opaque in mitigating with registrants. The deas use raise concerns as a background and that pharmaceutical supply chain must registration to control these substances. If dea wants to revoke registration, the standard is to show cause. The iso the alternative remedy. An extraordinary remedy. Distribute infrom any controlled substance medication before any due process hearing happens. To issue an iso the emma slater must find a registration provides a public danger. Ofil 2016, the definition imminent danger was left to the determination of the dea, reviewed casebycase by a judge only after the dea suspended the registrant. The lack of guidance plus shipping expectations generated great uncertainty in the supply change and have consequences. Community pharmacists described difficulty in obtaining controlled substances affecting the legitimate patients. In 2016, congress brought clarity. Congress to find danger for the first time. Both changes chambers in regular order. The legislation offered commonsense solutions. His characterizations have called for some to repeal the law. 20tics say the law passed in 1600 deas enforcement efforts in 2012 and 2013. Repealing the law would fail and reintroduce uncertainty and our business. The dea remains empowered to , a wideediate action range of additional tools which range from negotiations, voluntary action, to criminal charges and forfeiture. Consequencestended should bring subject to changes to congress. We will gladly work with you and the administration to adjust and identify these concerns if need be. My members are committed to be part of the solution. Opiates are a small fraction of medicines we distribute, we are committed to develop solutions for the challenges we face. I give for this opportunity. It has been a long time coming. Thank you for having me here. In the letter asking to repeal the law, it says it eviscerates the deas ability to act. You said that in your testimony. Question doesnt take a long answer. It is the second i would like to have. The first question, do you have data to support what you are telling us . If not, would you be willing to provide the data . Thank you mr. Chairman. Yes and no, if we have the data. It shows how infrequently isos are used. And with all respect, some of are looking at it from the wrong end of the telescope. You see how few there are, even you sell they, are in the Single Digits i think it was for 2011. Precipitously, and what that shows you is that the isos used extremely infrequently. Pass a law that makes it more the actualo use when numbers are in the low Single Digits does not make sense. I think you have a 40 year history of language that exists in the statute before last years act. Sen. Grassley maybe you could give some examples where the law is negative. We worked closely with the dea. We did a major case with them two weeks ago. Andave busted pill mills doctors selling prescriptions out of their cars. We do not have the authority to stop distribution. What we can do is catch it on the backend. It has not impeded our office. Think,retty clear, i from the article written by judge muldrew rooney judge law is at that the best unnecessary, and at worst harmful. Questionsley my first may appear confrontational, but not my second or third one. In advocating for change, wasnt the industry trying to weaken deas Enforcement Authority so your companies would not be shut down in the face of isos . That was not my take at the time this happened. I lived through the process of communication shutdown with dea when they changed hands in 2006. I witnessed listening to our members and the groups we put together to talk about this struggle mightily with determining standards and algorithms for determining what is a special order, what is a suspiciousness suspicious order. This went on for a number of years. I indicated in testimony the problem had been fixed and the enforcement was done. The bottom line is it appeared to our members that the goal line was being shifted. It was no steady state by which a company would look at an order and say, this is suspicious, i should report it. I can tell you anecdotally, one company that met with the field office sen. Grassley instead of an example you answered my second question. The guidance was two letters, to page letters that called for suspicious orders. There was no work under it. We asked, can you promote regulations. So we have an idea of what these terms in this letter means. We submitted over 40 questions three times the agency, never got an answer. The wholesale distributors were on their own developing their own algorithmic system. Some members had to do it by hand. Some had resources to invest in computers and make it more effective. They did this in the blind. The consequence was at the time when this opioid problem was beginning to expand, availability of these drugs became unlimited custom our members, the old adage, when in doubt cut it out, when the dea would not answer if that was his suspicious order, they would cut off the pharmacies. Sen. Grassley cant the distributors work effectively with the dea without limiting the eeas authority to make sure opioids do not fall into the wrong hands . We try to make that an hour daily delivery how the process moves and that it only gets to licensed pharmacies. We do not ship to anything that does not have eea license. License dea license. Ea, oure change at d members would agree the working relationship has been dramatically improved. Its of this law or the change, i do not know. There is more open communication line. I have had my own personal conversations. There is clarity. Dea put out a wonderful meeting a year ago. He outlined for all the heretrants, he said look, is this case, this is what we are expecting on that appeal, this is how that dea can use this. That helped our members understand where the lines are being drawn. That happened in the last 24 months. We will continue to work with them. Sen. Grassley senator feinstein. Feinstein i am from a medical family. My father was a surgeon and my husband who passed away was a surgeon. I am familiar with the term do no harm. In my view, this bill has done harm. I look at these figures and i look at the answers that we got from the dea and it seems to me we should look very closely at repeal. Is how don general you view the possibility that this could be turned into something that could be workable . There is so much money to be made and so much that has been made that it is very hard for me to see any amendments turning this around. Thank you, senator. Im not able to tell you how to fix this. The position i have taken with my colleagues the other 43 attorneys general, it ought to be repealed. We think it does do harm. I think opioids are overprescribed and taken to often. We are 4 of the worlds population, we consume 30 of the prescription opiates. We experience 27 of the Overdose Deaths in the world. That is an extraordinary relationship. Eight and a half times above our weight in terms of in terms of death. Pills for year for our country is way too many. We have to strike a balance. We want to make sure that people who are suffering horrible pain get the relief they need. We are so far in the other direction that we need not just a course correction. I believe that last years act went in the wrong direction, taking us back to where we were before is a step forward. Sen. Feinstein if the bill were repealed, what actions would you take . If the veil is repealed, states would continue to utilize resources they have and provide more cases over to the dea. If i can comment further, there is something wrong with the data , or simply the facts do not match. If we have a situation where they are reporting the issuance of isos were minimal against was still i guess wholesale distributors, the industry is saying it was a device that was threatening or stopping shipments, something is not correct there. Either isos were being issued or not. The industry was impacted or not buy it. The industry was impacted or not by it. Where are the safeguards if the dea is not able to stop that . That is where we think the law would need to be amended. In i am looking at this chart of isos suspension weres, and in 2011 there 65. I asked the question why, and it was the pill mills. Begin to drift down. In 2014 trip to down to Single Digits. Down to14 it drifted Single Digits. This indicates to me that the agency is not properly functioning because the suspension orders should be way up. Iso not know whether there interference. I know there is money to be made. Interference from the pharmacy industry or anyone else, but it appears to me based on these figures that the law is not working. Do you agree with that . Or do you find otherwise . We agree the laws are not working. Absolutely they are not working. Since the0,000 deaths year 2000. 2 Million People in our country are addicted to opioids. Theyre clearly not working. Sincefar as the laws, 2013, that was the high water mark. A systemic failure from overprescribing. Product is pulled by the prescriber, filled by the pharmacist, and the pharmacist orders to the wholesaler. The wholesaler only ships to dea licensed groups. There were systemic value of reporting. Suspicious reports were filed with dea, and yet there was no enforcement action. At the same time, companies were working overtime on these i. T. Systems. I would argue since 2012 and 2013, i heard a quiet down, the phone calls to me have quieted down, there is less and less concentration between dea agents and my members because i think my members are doing a better job now that they have self defined for each company. In do you really believe that . With all of the pills out there your members do not realize this is too many . The dea says that quota. Everyone statef any union orders this product, we ship. We are reporting our suspicious orders. There have not been i think as far as my 35 companies, it is tightening in the right direction to get this correct. Sen. Grassley senator hatch. To. Hatch i would like begin by thanking our witnesses for appearing. I would like to thank ms. Chambers was a constituent of mine. I think you have played an Important Role to bringing this to my attention. You have showed a lot of courage by being here. I appreciated. Frosh, about the letter you another attorney generals signed for the repeal of the bill. I found a letter curious because in the case of repeal, the letter essentially relies exclusively on judge mulrooneys article. It cites no data other than judge mulrooneys article in describing the laws impact. What independent analysis of the law did you and your colleagues conduct before deciding to send the letter . Evidently you read judge mulrooneys article, did you do anything else . Yes, senator. I cant judge mulrooneys article to be powerful and persuasive. But, there is no data since the law was passed, so we do not have that to work with. Each one of us, all 44 of us attorneys, we looked at the law, and i know when you try to prove a case, when a standard changes, it is significant. The change here is an extraordinarily high standard. When you have to proof a substantial likelihood of an immediate threat of death, serious bodily harm of a controlled substance, it is extraordinarily difficult. That is a very high standard. Any lawyer can tell you that it makes a big difference. There is no Statistical Analysis i can give you, but there is legal analysis, and it is shared by 43 other ags and we are divided among republicans and democrats. The report i referenced earlier, regarding what constitutes a suspicious order. What can trigger an enforcement action leading some distributors to decline to fill orders even when they have no evidence that a pharmacy or doctor was engaging in diversion. Can you explain how the absence of clear guidance and how the ensuring patient, address that particular problem. I cant. With senator feinstein, i think the key to this law, like any other law, we need to give it time, and find out if there are issues and concerns. After 18 months, this law has not been tested in the marketplace. Time will tell. If it is appropriate we will go back and amend. As far as the process unfolded, right. Our members struggle between 2007 and 2013 by numerous attempts to have meetings. I went to one of them. That happened to be the last meeting in 2010. We never met again with dea. We submitted written questions about the nature of suspicious orders. Getting into the location of pharmacies. Are then your pain clinics . State borders . What have you. We submitted this question three times and we still do not have any feedback. Our members had to go on their own initiative to try to define those lines. You indicated they stopped supplying with no evidence. I cannot speak to individual Company Decisions but i do know many of them i spoke with wood, would call me after their dea meetings quite honestly terrified saying look up i think theyre going to put my license. We are not sure if this stuff is suspicious. It is on the edge. Another problem is, when our members submit to one pharmacy a shipment of hills, we report that order whether it is suspicious or not to the dea on a regular basis of the dea has that but what is not told is that the dea also has data regarding multiple other distributors because many pharmacies are served by more than one wholesale distributor. The dea has all of this socalled data. I have asked the dea for years, can then dea look at us as partners in this and try to share some data. Full data so you can see the full picture of a pharmacy. So my wholesaler can look at and say, all right my shipment is kind of on the edge. If there are three of their wholesalers also submitted, that is clearly suspicious and we should cut them off. I have been asked about three times formally, can we do this. Can we get together . I keep getting answers, we cannot blind the data. I never believed the legal argument they like to use and that is fine but i sure wish it is a powerful tool here. Something that has our come up in this hearing. But if our sharing data would help clear up this problem, i have said it for years. If the dea sat down with my 35 members and constructively used arcos data data i believe within , 24 months most of the bad players in this country could be furred and very, very quickly as opposed to the game we have been playing. We have heard recently from forward dea officials expressing concern about the and sharing Patient Access act and other interactions with registrants. From your perspective, has communication with dea improved in the last 18 months and see months since the ensuring Patient Access act became law . It has. With the change in personnel, i was able to open a line of communication with the head of diversionn control. We had several conversations and the dea has been available for our conferences. They speak directly to our members. Instead of bringing the old slideshow they showed 10 years in a row, we now have new information they are shared sharing which i think is a , huge improvement. Moreover, as i mentioned earlier, we had a shareholder stakeholder meeting this spring and the younger attorney came in from their office to give his musing on the masters case and what it would mean if that case. The dea won that case and now my members have at least an idea of what they are thinking and terms of the legal boundary. I think it is 100 improved in the last 18 months and yes, i can be very complimentary of the dea since then and that was not the case in 20 2006 until 2016. Thank you mr. Chairman. I would like to thank those who testified today. The ongoing Opioid Crisis has harmed every single community, affected every state. My state of delaware lost more than 300 people who died of drug overdoses last year and what we are trying to do is strike the right balance between making sure people who suffer from persistent and chronic pain like ms. Chambers can get accurate relief and those who are abusing and misusing are appropriately held to account. Striking that balance is the purpose of our hearing. I would appreciate some pointed answers to some simple hopefully pointed questions. To attorney general frosch, delaware under the leadership of our attorney general recently enacted new regulations that allow prescribers to better monitor each opioid prescription and it limits and a firsttime prescription for more the end seven days except under exceptional circumstances. That has 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 that is being done in states like delaware . Yes. A number of states have prescription monitoring programs that 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. We have a lot of for the remains to be done. Help me, the dea use of immediate suspension orders has dropped but other enforcement tools like orders to show cause have increased. Are these other tools sufficient to combat the misuse or miss prescription of opioids . I do not think they are. You only have to 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 the wave of opioids that has washed across the country. So i would say not. You know, the prescription i would give is holistic. You not only need Law Enforcement introduction of illegal supply but we also need treatment, Prescription Drug monitoring. We do not have nearly enough treatment beds in our country and you know, we are not making forward progress. Were making progress but it is incremental. It needs to be much more rapid. I agree. What else do you think dea should do or we should do as a committee and society to address the significant problem of opioid addiction . We need a balance between access and effective Law Enforcement. We have not had time to analyze the data but if you look at the data as an overview, the dea has taken action in other areas to compensate for the inability or concern about time to take and i is so take an iso. In those cases, the standard works. You saw by the dated the amount of time the isos were used were limited. We think it could be used in very limited, very serious situations. You represent distributors. There have been a lot of concerns expressed. How do you think we can improve and sustain that working relationship we just talked about with the dea to crack down on inappropriate overprescribing behavior and make sure those who are genuinely in pain like ms. Chambers are genuinely able to access the opioids they need . First, let me say i think the dea agrees with us. There needs to be some definition of imminent danger. If its not the right one in the law than we should fix it. See how that works out. It may be a rush to judgment. It is probably not the most judicious way to do legislation but that being said, yes. I personally believe we can talk about the mechanics of Law Enforcement and Pain Management. Out of personal experience, this just happened to me, i spent 24 hours in a Major Hospital and i have had i now understand pain. I never understood persistent pain. Since august 3, i have had pain every day and my body in different places. From my shoulder down to my arms. It is miserable. Two surgeries. The most recent thursday to fix this bone and scope out this shoulder. In the hospital i was asked no less than five times, could you describe your level of pain. I looked at these people and said, it is not about the pain. The pain will take of itself. Well, you need to give me a number. What is your pain. I begin to make up numbers. Then they sent me out of the hospital after 24 hours with a prescription for oxycodone, we could not get it filled. My insurer would not pay for it. It was like, well so, i paid for it i use about five of them and that was it. I am off of it now and it was not good stuff. That it was surgery you know, it is a systemic 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 makes healing go faster. Let me just ask you, you conclude with what seemed an intriguing possibility that distributors and the dea could work more closely together to identify bad actors and allow the continued delivery of needed pain medication to those who legitimately needed. Need it. I have firmly held of the dea opened the door and said lets work with you as a registrant and not a criminal as used to be defined by someone in that agency, we are called criminals, if we worked as a registrant, i believe between the resources and access to information my members have, and then the Bigger Picture of information that dea has this should not be a problem to identify the bad players. I appreciate your testimony but as you represent those who struggle with pain chronically and daily at those who are charged with Law Enforcement and protecting our constituents, hundreds of whom are dying thousands across country and , those who are pharmacists trained to dispense appropriately, we have to get this right. We need a sense of urgency because there are literally people dying and suffering needlessly. Thank you mr. Chairman. Sen. Hatch one other thing he wanted for want to thank you all your testimony and your help to this community. This is important and we are all concerned about it. Weve learned a lot today. Mr. Chambers, were you trying to get our attention . Ms. Chambers the patients really want this law. We are so grateful it has come about and you guys have to talk to each other. We want the dea and the sugars the distributors and doctors and everybody to be talking so they know what the problems are and that they have communication about what the exact definitions are of what a distributor is in violation of what they are looking for. This has not happened in the past. We need this. Patients need access. My second point is that prescription opioids are only part of the opioid issues. The epidemic in the United States, theres a lot more going on besides that. 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 would not need so many opioids. Please. I hope every member of congress understands we do not have enough money. It is Something Like six cents per patient on Pain Research. We need a Pain Research institute. We need to our money into different pain treatments. Patient selfcare whether or not we have opioids, if we have another pain treatment. We just need pain relief. Especially severe pain. We are begging for help. Thank you. Thank you and thank all of you for your preparation and delivery in answering questions. Remember what i said to the first panel, you may get questions over the next week. Staff, notify all members. Get your questions in. We would appreciate your response. Thank you very much. Meeting adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] [captions Copyright National cable satellite corp. 2017] [indiscernible conversation]