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 it. Senator leahy 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 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 president e end of 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. Did. T want to know who 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 king 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 senator whitehouse 1,500 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 re 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 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 enhe forcement 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 . 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 mentioned, 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 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. Is the d. E. A. s how d. E. A. s position . Ms. Ashley its redundant and unnecessary and the reason is, when we engage with region strants, were having those 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 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 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 uestion. 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, senator blumenthal if yes, sir. Senator blumenthal thank you, mr. Chairman. Senator hanabusa 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. Senator hirono 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 other tools. 1,500 criminal cases, i dont know, compared to when . It sounds like youre doing going in the right direction but how does that number of criminal cases, for example, which is another tool, how does that compare over time to the number of criminal cases that d. E. A. Has brought . Thats what im going after. 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, e 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 the he had. It looks as though there is a decreased number of requests drug acturers for 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. 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 018 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. 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 time 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 villification 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 pursuing a carefully craft 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 enhe suring 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 suspension orders. As far as the orders for show cause goes, thats the corrective action plan where registrants are able to come back and 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. Doughertyy 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 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 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 publishcation 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 publishly apply on merits of laws that they are tasked withed a jute kaeding, why or 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 op ed by representative marino describing the originalins 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. Enator 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 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 deral agency or agencies allowed nine million hydrocodone pills over two years to be sent to a single four, y, not five, not not three, but one pharmacy in town of 392 people. Ats 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 with you. How does this happen . Ms. Ashley i can tell you we have processes, and since i had to beg 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. Ats 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. Like you to have whoever makes decisions at d. E. A. And justice to send me a letter and ay, this is what we need to doe 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. 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 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. 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. Ext 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 s held these positions since 2004. Es responsible for overseeing all operations of the health care ditory bution 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. 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 the hearing is going to continue streaming live online at cspan. Org. We are going to leave it there to take you live to the floor of the house about to gavel back in and starting its day with work on a bill dealing with Mortgage Loan rul
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