tv House Energy Subcommittee on Opioid Epidemic CSPAN March 21, 2018 1:45am-4:14am EDT
[inaudible conversations] >> we will call to order the hearing of the dea role to combat the opioid epidemic. today the subcommittee on oversight investigation has a hearing on the dea role to combat the opioid epidemic this crisis is a top priority of this committee and subcommittee. opioid -related overdoses killed more than 42,000 people in 2016 in 2016 with an average of 115 deaths each day estimated 2.1 million have the opioid use disorder since the earliest hearing the
subcommittee has been investigating aspects of this epidemic and in may 2017 opening a bipartisan investigation into allegations ofpi opioid dumping with and ordinate amounts shipped by distributors to pharmacies located in rural communities like west virginia and from press reports we have learned of shipments in west virginia that over ten years 20.8 millions were shipped to pharmacies in the town of williamson home of 3000 people. another 9 million opioids were distributed to a single pharmacy in west virginia to a population of 406. between 20,102,012 doug distributors had more pills in west virginia.
these raise serious questions about complying and to be administered by the dea. the csa was enacted in 1970 the law established schedules of controlled substances to provide the authority to be engaged in the manufacture, distribution and then to provide that all legitimate handlersd -- handlers would have a dea registration with the condition to maintain such registration must take reasonable steps to ensure it is not used as a source of diversion the dea regulations specifically require all distributors to report suspicious orders of
controlled substances in addition to the statutory responsibility to exercise do diligencevo to avoid filling suspicious orders. this hearing has two goals, first the subcommittee seeks to determine how the dea could determine to have suspicious orders of opioids and the massive amounts shipped to western virginia. the dea has acknowledged it could have done better to spot and investigate suspicious shipments and what were the deficiencies and has dea addressed them? dea has a comprehensive electronic database containing specific information at the pharmacyac level. could dea use that database more effectively too investigate divergent or compliance? the second adequately
protecting public safety. to build sharp white -- acquaintancesis are to know cause then that plummeted from former officials announced that dea office proved evidentiary in those orders that show cause commission. the lawyers and investigators resulting in the experienced personnel leaving the agency. the goals regulating controlled substances is to strike the right balance between public interest and
legitimate patients obtaining medication in a timely manner against another public interest with the legal diversion of prescription drugs particularly giving the rampant and deadly appeal on -- opioid epidemic our investigation is intended to assist the legislative effort to strike the right balance. it is unfortunate to get a battle out of the dea we had means recent progress but at this time our investigation still does not have a full picture. dea has made commitments that should help the committee gain information it needs and we expect the dea to honor those. and the acting administrator we have serious concerns about policy we need to discuss today but we are steadfast with our support and want to salute the dedicated workforce at the dea we need an
effective dea in this crisis i want to thank the minority for their participationorfo and hard work in this investigation i now yield to the ranking member. >> thank you so much mr. chairman and i am happy to kick off a series of hearings with the energy commerce committee this week with the oversight investigation and hearing. opioid overdose the number one cause of unintentional death in united states states every day we hear reports of americansic dying and often children are picking up the pieces and the reports are heartbreaking the crisis has had an economic toll estimate is it cost the country $1 trillion since 2001 and here is the point in my opening statement i show congress can still be bipartisan because today i want to talk about the continuingio investigation how exactly the epidemic developed
focus on must virginia which has the highest opioid death toll in the nation the numbers we are seeing are shocking and major news investigation reported that distributors ship 780 million opioids to the state between 2007 and 2012. in five years they shipped 780 million opioids to west virginia. focusing on west virginia but we are hoping the lessons we learn can be applied nationwide including my home state of colorado i joined the chairman to welcome you here we have a lot of i questions and we would like to know what you think failed us in west virginia and more importantly what we can do to avoid this
again. we know something went wrong. for example in the dea own or filing but also investigation found the number so if you work at one pharmacy which has a few hundred people they supplied the pharmacy with more than 4.3 million doses of opioids, more than 350,000 per month or in a single year than the next year, 4 million doses of that could think this was
legitimate? news reports described pharmacy workers filling bags of opioids over a divider and onto a counter to keep pace. one law enforcement agent said the clerk could not get it to closet properly. this isn't the only pharmacy to receive such massivef quantities between 2006 and 2016 distributors shipped over 20 million doses two to pharmacies in one town of 3000 people. i want to know if they dea things this amount of pills is excessive. in addition the control how
many pills distributed or sold land to the promisee and the automation of ports and how they used our data and if they relied on that to monitor the number of pills that distributors sent to west virginia todayly perform analytic assessments? or look at how many times and where do we shop and those that they send to pharmacies and letters sent in 2006 and six and seven the dea gave a list of circumstances that could be indicative of diversion thatnd claim know your
customers before shipping any opioids at all. did they meet this standard when they ship to west virginia and similarly did they comply with theirth obligations? and i want to know what the dea is doing right now to stop painkillers from flooding our communities we have had a lot of hearings on this but this is the first to look in a hard way at this crisis. we spend billions of dollars, countless hours and here we are. >> all of this is supposedly illegally. it needs to stop and stop now and how wee protect our constituent.
>> chairman thank you for your leadership on this issue to who we represent. this committee has been investigating the pills ship to pharmacies in rural west virginia thenu numbers that we have seen are nothing short of staggering more than 20 million shipped to our town of a population of fewer than 3000 people another pharmacy 2000 people received 5600 prescriptions per day during a single year. part of the investigation looking at the estate pharmacies and during last very straightforward question so which provided the number
one center range in the tight -- entire united states of america. so after the extended and unnecessary delay we finally received the d data does not know the answer to the question this is not the end of the matter. we have learned in 2082nd location open just 2 miles away from the original pharmacy and the second was now in most instances it would be a success story but the original pharmacy that receive 9 million pills in two years stayed open for another two years. and if number one and if number one pills into the community so how did that happen? how is thatw' possible?
and with both locations as well will and they sought customer sharing drugs in the parking lot and if you heard a cash torso she could not close and this game may have. >> but it did not shed both at the same time and they were part of the scheme nda has acknowledged and in this case and is and then the effective in spite of the many solutions needed to combat the crisis.
.. .. s investigation. while progress is being date in dea's efforts and i appreciated our meeting on friday we still have plenty of unanswered questions coming into today's hearing. i hope you can learn answer the answer to those questions today. i'm also pleased with the commitment dea has made to fill our remaining requests in this investigation and i expect those commitments to be honored period but if they are not we will be talking again soon to your most pressing questions are intended to get dea on a better path. everyone of us on this dais in this room support a strong and effective dea. we know you have an important job to do. we are grateful to all those in law enforcement personnel at your agency. we want you to have the tools and the resources you need to help us combat this epidemic
amongst the many other duties you have a ta. want to thank you for being with us today and administrator patterson and we look forward to your candor. that likely yield the balance of my time to the gentleman from illinois to remind the committee we left full two days of hearing starting tomorrow and her stay to review 25 pieces of legislation on bail. epidemic in the hope expect everyone on the committee to attend those hearings. without i yield to the gentleman from virginia. >> thank you mr. chairman. we ever constitute responsibility conduct oversight and ensure the substance act strikes the right balance between the public interest in obtaining medication against the weighty interest in preventing the illegal diversion of prescription drugs. the issue is whether dea is protecting public safety. dea reveals a sharp decline in immediate suspension orders, iso since 2002. they aren't administrative tool not to punish the protect the
public from rogue pharmacist who would continue to provide opiates of drug abusers unless the registration was majorly suspended. former officials alleged in the "washington post" and on cbs "60 minutes" starting around 2013 evidentiary requirements from the dea. dea patents provided this committee with substantiation of this allegation. isos remind me of dui cases in virginia. one of the seltzer takes a driver of the road who's been drinking their licenses administratively suspended to protect the public. the trial on the merits is delayed but not public safety. immediately suspend the rogue operator and protect the public. i yield back. >> the gentleman yields back per the chair will now recognize the ranking member of the full committee for five minutes. >> he opiate epidemic continues to devastate communities in every part of america and
everyday 115 americans lose their lives in the opioid overdose. we must help the struggling with addiction i'm committed to working with all of my colleagues to add meaningful legislation resources to help combat this crisis. families across this nation are looking to us for help and it's my hope that dea will work corporately with us and as ever. titian to efforts to respond to this crisis congress has a responsibility figure out what went wrong and how what went wrong and how to make sure something like this never happens again. that's why this committee is engaged in a bipartisan investigation in the rolled dea and drug distributors have an address in the ongoing opioid crisis and protecting the communities that have been overwhelmed by this epidemic. i hope the lessons learned will address the problems throughout the country from new jersey to west virginia and beyond. clearly something went wrong.
our committee's investigation has found drug distributors ship ships millions of opposed to small-town pharmacies in west virginia every year. for example of pharmacy in a town of 2000 people received-- doses of opioids over a ten-year period and there were other pharmacies in the areas well. there's simply no way there was a medical need for this incredible volume of opioids in the sparsely populated area. i would hope dea can tell us what broke down and the safeguards that should have protected these committees from these practices. for example i've questions about the data that dea collects and why they did not use the more aggressively to prevent the oversupply of opioids in certain cases. we know distributors are required to tell dea how many pills they ship each month and where the telescope is not clear bea has used this data in the past to help curtail excessive
pill distribution. distributors are also required to alert the ea one of pharmacy places an order for what appears to be a sufficiently large quantity of pills. it appears distributors have not always alert dea of those orders and may not even have systems in place to identify inappropriate to-- at the same time it's not clear if dea has done enough with the orders they receive from distributors to alert the agency of thought possible analogous shipment. when multiple distributorships to a single pharmacy causing oversupply is not good dea has inadequate system to identify and flag the distributors that oversupply problem may be unfolding but unlike dea who has access to conference of distribution data distributors can only see what's applied to pharmacy. dea is not liking when multiple
distributors are at risk of collecting the oversupply to pharmacies and the result is a failure that can lead to diversion. it seems like he failing to report suspicious orders by distributors have-- the ability to monitor the issuing of controlled substances. i'd like to know what tools the ea needs to help enforce this requirement. at the same time i hope dea is making full use of suspicious orders when they reported. finally mr. chairman wyler investigation closes in on what went wrong we also want to know want to nod dea's monitoring distributors across the country now are addictive drugs-- and now new opioids are making their way to the market but i hope that dea is actively or proactively analyzing the shipments of these pills and where appropriate stepping in and stopping the over distribution of these drugs.
i just want to thank administrator patterson for appearing before us. this issue is extraordinarily important and no one can address alone. dea and congress must be allied in combating the opioid crisis and only by understanding what went on can we stop in the future. again i know you are in the hot seat today but it's something we need to work on together. thank you mr. chairman. >> the gentleman yields back. i ask unanimous consent of the members written opening statements be made by the record and without objectionable pants and the rekha. this i ask unanimous consent the energy and commerce members and subcommittee on oversight investigation be permitted to participate in today's hearing the without objection, so ordered. i'd like to do so with us for today's hearing. today we have mr. robert patterson the acting administrator for the drug enforcement administration. we appreciate you being here with us today mr. patterson and
you are where the committee is holding an investigative hearing and in so doing it's been our practice to take testimony under oath. do you have any objection to testifying under oath? the witnesses has anticipated no no, saying his response is no. the chair devices you under the rules of the house the rules of the committee you are entitled to be accompanied by counsel. do you desire to the company by counsel during your testimony today? he responds that he does not than in that case i would ask that you rise and please raise your right hand and i will swear you in. do you swear that the testimony you're about to give us the truth, the whole truth and nothing but the truth? you are now under oath subject to the penalties set forth in title xviii, section 1001 of the united states code. you may now give a five minute summary of your written statement. if you can hit the button on the mic and you have five minutes to
summarize your testimony. thank you again for being here mr. patterson. >> would the chairman and subcommittee chairman harper ranking members pallone and to get and distinguished members of the subcommittee thank you for the opportunity to be here today to discuss the opioid epidemic and the dea's eight-- the dea's roan combating this. over the past 15 years a and nation has been increasingly devastated by opioid abuse and epidemic fueled for a significant period of time by the overprescribing potent prescription opioids for acute and chronic pain. this indiscriminate practice created a generation of opioid abusers. presently estimated at more than 3 million americans. over the past two years we have begun to see a dramatic and disturbing trend producers of an increased awareness of the opioid epidemic prescriptions are opioids have started to decline. organizations in particular the
well-positioned in particular the well-positioned in mexican drug cartels to fill this void by cheap heroin mix with fentanyl and fentanyl related substances and selling it to users into traditional powder form and in some cases pressed into counterfeit pills made to resemble a list of pharmaceuticals. there are syndrome is the dea's addressing is part of the collective efforts to turn this tide. the third piece must also be addressed. first and foremost is enforcement. based on our investigations actions are undertaken every day using her criminal civil or ministry give tools to attack traffic of illicit drugs and the diversion of alyssa's supply. second is education. we strongly believe there's a value in the natural fit for the d.a. into the space and look whenever possible to partner with leaders in prevention education. the dea's committed to doing
what we can in drug treatment and recovery services working alongside our partners the department of health and human services using strategies that minimize the risk of diversion during this public health emergency. the only way to fundamentally change this epidemic is to decrease demand for these substances and address the global illicit supplies that concerns the efforts of dea and all of its partners. the action that dea diversion control division are critical with respect to addressing alyssa's supply to diversion of prescription opioids by a few as it does proportion impact on the availability of prescription opioids. the fact remains a majority of new heroin users that stated they started their cycle of addiction on prescription opioids. the result we are constantly evaluating ways to improve our effectiveness to ensure more than 1.7 million registrants
comply with the law but our use of administrative tools and legislation to change her authority in this area has been subject to numerous media reports. let me address that issue up front. dea is continue to revoke approximately 1000 registrations each year toward ministry that tools such as orders to show cause immediate suspension orders and surrenders for cause. we have and will continue to use all of these tools to protect the public from the very small percentage of registrants who exploit human frailty for-profit for-profit. where license revocation is not necessary we have aggressively pursued civil actions and ensuring compliance. over the last decade dea's levied fines totaling nearly three and a $90 million against opioid distributors nationwide and entered into mou's with each. dea has reprioritized a portion of the criminal investigators and diverse investigators and enforcement groups referred to as tactical diversion squads.
.. he just completed training 13000 pharmacist, pharmacy technicians and they only fill valid prescriptions. in may, dea will initiate similar nationwide effort to provide training on the vital role that prescribers play in curbing this epidemic. this effort will start with specific focus on the stage where we've seen little decrease or, in some instances, an increase in opioid prescribing
rates. administrative action, so bicycle cases are all important steps where we have fallen short in the past it is by not proactively leveraging the data that has been available to us. i'm happy to discuss what happened in the past i focus my time on moving our agency forward and appreciate the opportunity to update you on where we are today and where we intend to go. for example, in january we utilize our data overlaid with data from hss and one available state pmp programs for the result was proximally 400 targeted leads the dea was able to send it to its 22 field divisions nationwide with further investigation. while we are working with the federal agencies in the space, i'm sorry, we are working with the federal agencies and space we continue to work well for colleagues in a windy seat, ccd, the mutual issues that we face today have stronger and critical partnerships with fda and hhs. two. i say i'd like to recognize the
subcommittee's efforts to hold a legislator. starting tomorrow and more than 25 pieces of legislation in that effort not underscores the unprecedented and demonstrates that we must all take action to address the store together. thank you for this opportunity and i look forward to your questions with. >> thank you mr. patterson. he will now be the opportunity for members to ask you questions regarding your statement and look for solutions with the problems we have will begin by recommending myself for five minutes for questioning. the past year this committee has been investigating opioid dumping and it is part of this probe committee found some disturbing examples. i will share a couple and some we have touched on. a single pharmacy in mount shamrock, west virginia, population 1779 received over 16.5 billion hydrocodone and oxycodone between 2006 and 2016.
peterson 20.8 million opioid to williamson, west virginia, population 2900 during the same period and in 2006 pharmacy located in kermit, west virginia, population 406, ranked 22nd in the entire country in the overall number of hydrocodone pills it received with a single distributors supporting 76% of the hydrocodone pills that your. would you agree that it bases representing in ornament amount of shift to such will market. >> i would smack distributors are required to file reports of shipment amounts for certain controlled substances to the dea database called the automated reports and consolidated ordering system or arcos. these reports are filed monthly, is that correct? >> they are monthly or quarterly. what is the distinction between 11 is done quarterly or monthly question. >> it is done by, i believe, the distributor or not whether it's
the distributor or manufacturer. >> ten years ago the arcos database with a have been able to flag dea about unusual patterns such as the starting monthly increases of shipment amounts or disproportionate volumes of controlled substance it sells at a pharmacy? >> ten years ago, i think that would be double. >> did the dea attempt to leverage the data in arcos to help support dea investigations of opioid, diversion in west virginia? >> back at that time frame? >> yes, tell me when do they start utilizing that. >> arcos data, i think, we probably in 2010 was an extremely manual process and as it has gotten more robust and certainly the last handful of years we've use that in a proactive manner.
>> would the dea be able to flag such signals of opioid diversion today and your answer is obviously yes. in 2006 in in 2007 dea sends at least three letters of wholesale drug distributors regarding their compliance obligations under controlled substances act and the letter reminded the company's to report suspicious orders of of your idea during this time according to dea enforcement actions drugs to readers failed to maintain effective controls against diversion. why did the dea communications with industry failed to prevent the kind of measure breakdowns that appear in west virginia? >> i think we go back to that time frame on the suspicious orders there are major failures. one was either a lack of information contained therein or not filing them in this instance that they had.
i think that started the problem quite frankly and in a lot of the frustration came from chasing down the registrants and ultimately reminding them of their responsibility in this regulated area. >> over the last ten years the dea reached settlements with drug distributors to maintain effective controls against diversion against opioids and to fail and after the settlement drug distributors continued to comply with the regulatory requirements. why were these initial sediments not active in achieving compliance from these distributors? >> again, this goes back to the frustration of the day and i know that the folks that were in diversion back in 2010, 2012 struggled with the fact that these mo use or am always have been put in place with these companies and they blatantly violated them again.
>> how is dea utilizing our guest today? is it effective today? >> arcos is a standalone database and it's a good pointer and i think as i said in my opening statement arcos data and what we have learned combined with the state pmp and hhs data gives you a much better outlier problem and in some of the cases that we look at in the situation we look at arcos data would not have found those particular issues and if it's a smaller level or a single place what we need is these data sets that are working in conjunction with each other. >> is that constantly monitored and updated and revised? >> we are constantly working with the standard now in a proactive way and we joined with two state coalitions, state attorney general's to work with data sharing in the space especially with the pmp data as well as our counterparts at hhs.
>> thank you, mr. patterson for the chair now recognize as the ranking member from colorado for five minutes. >> thank you. i agree that this to patterson, we do need to look for how we can improve things but i don't think we can do it without examining the past. this arcos system is the perfect example. i want to spend a few minutes following up with the chairman was asking you because you said my understanding is arcos was in place during this whole time. from 2006-2016, correct? >> that's correct. >> and so forth happening the data was being reported in but nothing was really being done with it is that correct track. >> i would say it's in a very reactively. >> right. so you said that a lot of times it wouldn't have been able to tell this from arcos but i'm going to assume that if he had
been analyzing the data we would have found the pills every month that they were sending if someone had looked at it, what you think so cut part. >> i do agree that. >> and wouldn't you agree that in kermit, i thank you said yes, when the chairman said this that it was two-point to million pills in a year in kermit and all you would have to do is look at that rot data and see that, what you question. >> that's correct. >> and so really the fact and let me ask you another question that the controlled substance and the applicable regulation required the distributors to know their customer so the distributors are supposed to report unusual and substantially from a normal pattern to the dea and is in back packs. the dea has to analyze the arcos
data and identify problems but even before that distributors have a burden, right? >> the key burden is on the distributor. >> right. exactly. do you think that if you are the corporation and you are looking at all these prescriptions in kermit that you would think that would you think they knew those customers? >> well, one the obligation was there to know their customers. >> right. you thank you could possibly know the customers when you're sending that many prescriptions in there? >> i think the answer would be that they did their part on this. >> what is your answer question. >> obviously i think they should have done more. i think so. orders of this magnitude using two-point to million doses of hydra coding to one say right pharmacy do you think that is an order of the usual size? >> i do, ma'am. >> and you think that it deviates from a normal pattern? >> i do. >> let me ask you another
question looking back on this case do you think that in the distributors in all of these situations of the chairman i have been talking about do you think that they failed to adequately do due diligence over what they were doing. >> certainly on the appearance of it but i can't tell you what their due diligence was but. >> you are not here to represent them. in december "the washington post" 60 minutes reported that they distributed large volumes of opioids from aurora, colorado and distributions facility in 2000. one pharmacy the received these shipments reportedly sold as many as 2000 opioids a day. have you retroactively applied arcos data's to the colorado situation to see if there were distribution pattern similar to what we saw in kermit, west
virginia? >> i believe that is the case but that would obviously be litigated and receive a settlement. i don't know if they went back and if it currently i would to that same number. >> and what was the settlement? >> it was $150 million. >> from that company to -- >> the us government. >> as a result of their failure to adequately follow the law on distributing those opioids, is the right person. >> yes. >> and what do you think congress can do so that we don't have a total slipup like we did in all of these cases in west virginia and around the country, really? >> i think, look, the fundamental change that we have all ready made is our recognition of how we can use the various datasets and paying attention to what we're doing. the outreach to industry and this is a topic that i will assume come up at some point.
we have to work with the industry and the industry honestly has the responsibility but we have 1500 people to monitor 1.7 million registrants. >> you think the initial burden to assess this is on the industry but then the dea has an important enforcement -- >> oversight. >> thank you, mr. chairman. >> gentleman yields back in the chair will not recognize the chairman of the pool committee mr. walden for five minutes. >> thank you, mr. chairman. mr. patterson, we need to find out whether the dea is addressing the lessons you say they have learned. case in point is a when i raise the question regarding the same) in kermit, west virginia. i mentioned in my opening statement that it was shut down in 2009, correct? >> i don't know for specific dates. i know there were two pharmacies and one was shut down and with criminal. >> our data since april 09, the right one is not shut down until
over two years later when the owner of the pharmacy entered a guilty plea to charges that he illegally issued discussions, correct? >> is correct. >> and in april 1 of 2009 an article in the local herald dispatch reported that the to say right pharmacies our local pain [inaudible] the article reported an affidavit federal investigators stated there were two overdose deaths late to this network. my question is why did dea shut down the right number two but not say right number one in april 2009 if both pharmacies were part of a network linked to deaths? >> i have to get back to you on that particular issue and i'll tell you why because my understanding is part of the criminal process in the case. i don't know the answer but i'd be happy to get back to you. >> thank you. why would the dea consider such an arrangement when it knew that
the owners 2 miles apart one of which the dea claim to be the prime reception location of a flood of pills and that's a direct quote being sent to link to the overgrowth deaths -- same owner, same operator, time apart. >> all have to get back to you. >> this pharmacy received somewhere between one and 2 million hydrocodone and oxycodone pills. it allowed the right one to continue to dispense such a volume of opioids oppose a continuous to help public health and safety. is that right? >> i would agree. >> mr. patterson, what is the biggest priority public safety rated ongoing criminal investigation. >> it should event to protect public safety. >> so in this case the government originally entered a plea with the pharmacy to not even call for any person to. the lack of any person time troubled the judge and eventually the defendant was sentenced to six months, six months in prison. what kind of evidentiary challenges would have been
involved in such a case and would put immediate suspension order on hold really help solve these challenges? >> putting an immediate suspension on hold again i don't know the particular facts and i'm happy to get back to you but i will tell you that i have a strong opinion and this has been relayed throughout our agency that whether it's in immediate suspension or a surrender for cause where having public harm issues than that suspension needs to occur in lieu of chemical prosecution. >> have you come back and looked during the records that would speak to this issue of why the decision was made? >> i'd be happy. >> and we provided those to us unredacted question. >> i would be happy to take a back. >> that wasn't the answer i was looking for.
>> i don't want to commit to the department files but i'd be happy to take that back and i'll take your concern back about getting them redacted. >> we have had this discussion private and will have it in public and will have it in private. the long and short of it is we want to find out what was going on and what was the thinking and why the change in operation, people died and things went on. we want to see your agency repeat that we are home to the constituents we represent and i think the public has a right to no, don't you track. >> i fully understand your concern and i agree with you. this happen again today? >> i certainly think with our mentality the answer would be no. what we wish to do is stop public harm. i've had this conversation with us attorneys population states attorneys and i see into many incidences on isos, current ones that i sign off on where there has been a delay that i don't find appropriate. >> how do you know when to proceed versus a criminal case. >> i would take it notably the we do it in the case of the
field. in this case i find that we have the ability so we have certain protocols where we evaluate risk of ongoing criminal activity in traditional criminal cases and in this case because the person has a registration we can really stop at harm. >> was immediate is at 90 days, 20 fridays, 12. >> i think the frustration is this is it takes time to build even that iso charge which is the reason why in a lot of cases we have gone to surrenders for cause or voluntary surrender and in which we go on to remove that registration. >> so the iso how long are we talking about. case? >> i think in an efficient manner, 45-90 days. >> so during that period they can continue dispense these drugs? >> the same way and let the person would be out of the street as we gather the evidence we need to present the charge. >> that is why, i go back to my point on surrender for cause or voluntary surrender. if i can walk in and lay out to
that person why they need to surrender that and i can do it in a day and that's the method that we've been using much more aggressively than the iso process we will do that. >> what's the average time to get to voluntary surrender? >> it spends. we are very aggressive people and it happens relatively quickly and there's always a quick balance criminal case and evidence they need to look at for that and like i said, our conversations with prosecutors and in the field had the decision has to get me quickly. >> i know my tired time is expired and i imagine that he will have a comment or two on this as well with that, i yield back. >> thank you, mr. chairman. the chair now recognizes the ranking member of the full committee for five minutes. >> thank you, mr. chairman. i wanted to ask you about another pharmacy in west
virginia so i can better understand why dea was not able to stop the distributors from over supplying certain pharmacies and this one is the family discount in mount gate shamrock, west virginia, with a population of just under 2000 and dea data shows the distributors ship millions of -- by contrast the writing pharmacy to mistreat received a total of about 2 million bills during this entire 11 year period. do you agree that over 16 million bills is an excessive amount of opioids her family discount pharmacy to oversee results relative to the size of the town it serves? >> especially when you compare to the other pharmacy.
correct. >> pinky. one distributor has provided evidence that between may 2008 and may 2009 they sent dea 105 suspicious order report stating that this pharmacy regularly ordered high volumes of pills for example. this distributor apparently told dea that family discount ordered 25, 500 count hydrocodone bottles on june 16, 2008. that's 12500 pills just in the one day and on october 10 they ordered 32, 500 count hydrocodone bottles or 16000 pills in a single day again for a town of only 2000 people. merely reporting these suspicious orders does not resolve the distributor of its positional responsibility. is that correct? >> that's correct. >> distributors still have to actually refuse shipments to suspicious pharmacies question. >> began, yes. >> additionally it appears that the jupiters continue to ship this pharmacy over a million
opioids in the five years after the reports were made and the distributor who told us they reported the pharmacy to dea continue to supply them after submitting those reports. mr. patterson, it would appear that something broke down to allow so many opioids to be shipped to this pharmacy and just tell us what happened here? why were so many sent to this pharmacy the same time dea has received a number of suspicious order reports and what you think happened? >> sir, again will have to go back and take a look at the specific inferences of what happened but i will give you that i think the concern i have with the arcos, not just arcos data but the suspicious orders that is was a decentralized function and would go out with the vision of those reports and we are now bringing those in as well to our headquarters for proper deconstruction of visibility of what we see. on face value, the facts that
does proper to me and i be happy to go back and take a look at the family discount scenario. as i sit here, i don't have the particulars on that case from the time. >> we appreciate you following up and that's why and i don't expect you to know but from 2006 and 2010 did the dea have any data analyst assigned to scrutinize information from distributors about the amount of the ship to particular pharmacies and did you have a data allen list in that respect? >> my understanding of the people that were handling the arcos data it was a completely manual process that was coming in on paper or tapes and have to be verified so you have this one month, three month delay to begin with and they would have to have errors in the report that we go back and forth so what you found yourself with is a set of data that sometimes
would take a year plus to get correct. in that timeframe, sir, we were using it very much as a reactive tool. in other words, someone would come in and provide some piece of information on a pharmacy or a doctor or some other impact or some other issue and then they would go and look at the arcos data. if not done -- >> does that mean then if i understand you that they it would be too long a period of time before they realize how excessive this was a smart. >> well, it was still ongoing obviously and it would be an ability to look at the current situation and a lot of these cases you see for these problems occurred for either a year or two and then disappeared or they were ongoing. >> if that problem been corrected or what you suggest we do. >> it has been corrected, sir. again, i think the committee to understand arcos is an externally different tool and in 2018 that it was in even in 2010
or 11. >> you feel you have the tools to correct it and you don't need it at the house? i feel that tool without a data is an important way to look proactively at these issues with a very specific issues. >> thank you. the chair now feels back at recommends is the man from texas for five minutes. >> thank you, mr. chairman. this is a difficult hearing because everyone has the same bottom line but your agency doesn't appear to be willing to aggressively try to help us solve this or at least deal with this crisis. according to the latest numbers that this committee that 150 people a day are dying of opioids overdoses and two thirds of those are illegally prescribed drugs. about 80 people a day are dying
from taking legally prescribed prescription drugs and they may be getting that prescription in an illegal way and another what they don't really need it. you are the head of the agency that is supposed to do something about it and i don't know much about you but apparently your background has been on the ileal of dea, is that correct? >> that is correct. >> how long have you been in your current position? >> since october 2070. >> and i doubt that you volunteer for the job and you don't we don't have we still don't have a trump administration appointee who has been recommended to the senate in so for the foreseeable future in terms of drug enforcement the buck stops with you even though even as i understand it your career civil servant from is that correct? >> escort. >> are you familiar "the
washington post" articles that have been running the last three or four months and one of them talks about the tension between the field enforcement offices in the washington administrative officials? >> i have. >> okay. you agree or disagree with the basic thrust of those articles and the enforcement people were very enthusiastic and willing to go after the distribution centers and the drug manufacturers and the pharmacist, pharmacies and the washington staff for lack of a better term, storm water or tone them down? >> , i believe that is an overstatement and i thank you have a number of issues that quite quickly, play out in this
space and some of which have to do with personalities and i don't find the folks in the field have this belief that they were shut down and i think they were people that felt that way at headquarters but not necessarily in the fields. are you familiar with the gentleman [inaudible] >> i am spirit you don't think he stonewalled them or turn them down or tone them down. >> sorry, as i talked with everyone i met on this situation i will simply explain this. i could put three people in a room and talk about probable cause and they could all have different opinions. >> let me put it this way. you and your associates in washington have stonewalled this committee for the last six or seven months. it took the threat of chairman walden subpoena the attorney general of the united states to finally break with documents. we didn't get those documents, i understand, until yesterday.
that is not "the washington post", sir. that is your people in washington interacting with energy and commerce committee staff on a bipartisan basis and that is not hypothetical and that is real. now we are as much as part of the problem is anybody because the congress is not aggressively addressed it but we are beginning to. as long as you are the head of the dea i personally as vice chairman of the committee expect you to work with us and to tell your people to work with the committee staff. can you do that? >> sir, i took of his job in october and i met with -- >> i want to know will you do what i just asked you to do, yes, sir no? will you tell your people to work for committee staff to address this problem. >> of course. and i have been since october
and -- >> you didn't turn them in until yesterday, sir and some of the documents you turnover were so redacted that it looks like black marks on a page. >> sir, we've been turning documents over since november. ... and i appreciate that. >> i am fully committed to working with this committee being as transparent as i can be. >> remember it e.g. people a day are dying because of legal prescription drugs that are probably being a legally
prescribed. >> the gentle man yields back and will recognize ms. castro for five minutes. >> administrator, i am sure you know about the multi-district litigation in the northern district of ohio which consolidates over 400 losses brought by cities and counties and other communities against the drug distributors and manufacturers and pharmacy chains. the most important source of information into major lawsuit is going to be most likely the dmarko status and they understand initially they resisted providing status to the federal judge. the dea officials testified in response to my question in the committee hearing last month that the resistance is based
upon the need for proprietary information. describing how the party should treat the confidential marcos data when they disclose it. the status will be pivotal. they've agreed to provide nine years of data on the opioid sales including the identities of manufacturers and distributors that sold 95% of the opioid stage from 2006 to 2014. this will not be the last major challenge to manufacturers and distributors and others that are responsible.
dea cooperate in those cases and have you set out a stand or at is this the position going forward but other judges and litigants can count on? >> it is under the same circumstances and conditions for anyone else that came in under those same terms. >> when will it be provided in the northern ohio case? >> i think it is very short term. >> of the analysis of the data has been very concerning. we just skimmed the surface i think my colleagues have outlined some of these. i am concerned there are other regions across the country. that information may be
overlooked. how is the dea could simply using the old data safe from 2006 to the present to go back and look at past crimes, and if you could explain what you're doing now. >> i appreciate the question and it's an important issue. the packages we just put out our current day practices we want to investigate. it's where the outliers are we want to go back and look at why they are occurring. some are reasonable issues. there is an oncology department and a high year full of -- higher your level of medication going on. when we get these issues we are dealing with me want to roll back and look at 2013, 14 and 15
with the ability to take a look at the data so it makes sense. there's a number of cases without going into detail looking at just that issue right now. >> what's the statute of limitation if we go back and the committee has seen some of this layer is ramped up and then because now the spotlight is being shined on a and it's scaled down do you have the ability to go down and hold them accountable for that dangerous distribution of opioids? >> i'm not sure how far it goes back, but as long as it is an ongoing issue than you fall into that timeframe. >> there was a lot of criticism of finding the pulitzer prize-winning charleston mail that the state didn't take
advantage of in their fingerti fingertips. how are they providing that data so they can hold folks accountable? >> this gets back to the issue why they are so critical with each other. we see the distribution to the pharmacy. the data will then show the distribution so the whole connection is where the other outliers become critical to take a look at some states and this is the issue that we have addressed throughout the members we've been through the states. frankly it is an issue i would hope someone looks at on a legislative fix at a minimum to make the states cooperate with each other and we are still not cooperating with each other
which is how a lot of the estate version happens. other roughly 9700 pages we have received have come in during the last month. yesterday the dea brought up some and i know those documents don't contain some reductions, so there is much work to be do done. i will continue to work with you on this effort. now the chair will recognize the vice chairman of the subcommittee, the gentleman from
virginia mr. griffin for five minutes. >> i'm going to need your assistance on some of this to ask questions that require a yes or no answer. if you could take a look at the e-mail before you dated 2011 i would ask unanimous consent to put that in the record. and apparently the secret name is blacked out, the first most prominent social responsibility is government officials is to protect the public. i think that trumps all other activities and what citizens would expect us to do. you agree with that statement don't you? one of the key tools is through an immediate suspension order referred to as an administrative tool used as an emergency intervention to stop them from
continuing to prescribe or dispense opioids that could kill drug seekers or put the public at risk. you agree with that as well. a pharmacy in florida received an increase of oxycodone of almost 2500% compared to one year earlier. in the parking lot of the pharmacy for selling and trading pills police officers were concerned customers were getting high in the parking lot and getting on the road to endangering the public. the continued distancing by the pharmacy with its parking lots of drug pushers in users would get high o on that road didn't e an imminent danger wouldn't you agree yes or no? you woul but also in may i assue speed is crucial in the imminent suspension orders to protect the public yes or no.
please refer to another e-mail before you and ask unanimous consent there's two different dates on it. the e-mail chain august of 2013 shows the lawyers are requiring people to submit an expert witness report for the assessment of data and documents prior to submitting either or both requests for an immediate suspension order and are you aware of the new requirement imposed? i expected that. regarding medical experts of the council said to be clear this isn't a office requirement policy, it is the requirement of the administrator and th and the courts.
are you aware they are required by the administrator yes or no? as a general matter the cases without expert's testimony are the exception rather than the rule so they are requiring the testimony before the fueled cans at to the chief counsel's office for the review. the case. this decision says that the state doesn't provide guidance on certain medical standards, they must use an expert to explain why the activities fell below the standard and however you wouldn't need a medical expert if they had a statute of regulations on prescribing standards yes or no.
i know you are trying to shift from some of that but it would take time to find a medical experexperts wouldn't you agree? to meet the fee and developer doubles isn't that true? >> it would require some kind of compensation. >> the medical expert wit medicd need to review the program data, patient files and other information that's going to take time for the experts to review and render an opinion isn't it? after completing the review in the chief counsel's office would need additional time to review the submission of the request for the suspension order isn't that true? realistically the scenario sees no delays along the way and it will take the that's where you
get the 45 to 90 days. if the restraining order is against, they would get a medical expert through the steps we just went through and would weaken the case in court within the? so in fact assisting on the testimony i get the trial but to protect the public insisting on a medical expert and advances and endangering the public and the case because it takes away the immediacy factor wouldn't you agree? thank you mr. chairman and i will yield back. >> the chair will recognize the gentleman from california for five minutes. >> thank you for coming.
i can't tell you how personal i take it from when a patient con overdosed, not breathing. it isn't uncommon to see a blue colored patient being struggled and in an emergency situation having been dumped from a car found this person overdosed and not breathing. we cut through the chase and start resuscitating the patient and we know what to do no matter if it is from overdose opiate or any other reason why a patient is comatose. i'm going to cut through the chase and ask you to be very frank and direct. are you sure that they knew
there was a lot of opioids being shipped in an extraordinary amount and when you said earlier that there's two things you were going to do from now on it is concerning that they were to recognize how to use the data and pay more to what you're doing that leads me to believe you are collecting data. what are you doing different now that you've are going to recognize how to use the data? >> i appreciate the concern and try to explain when we are talking about a lot of these cases we talk about a time. >> i would rather be specific on what are the changes now bought reasons or an excuse, but aren't
you going to do that's different? we have a website that has been built for the distributors to understand the customers where they can see a partial information on other people distributed to the pharmacy for the past six months we are looking at it in a proactive manner. >> what numerical equal asians have you used to flag something for the pharmacies and distributors? >> vr baselines for any area as the traditional and anything that is an anomaly to that is a
flag so when we've talked about these issues before -- >> who is the one in your department putting their eye on the computer? >> the unit on the diversion. >> again most of us generated by computer so it isn't necessarily a manpower intensive endeavor to build. when you said now you are going to start paying attention to what you're doing what are the organizational changes that you've made to pay attention to getting the job? >> we have been doing it for a period of time. >> now what you have to do is pay attention to what you're doing and that seems to imply there was a slipup before so what are you doing and what is the chain should.
to make sure that this doesn't happen again? >> some of the issues i talked about and how we use the community outreach with a prescribing. have you increased the staffing in certain areas and what are you doing to pay better attention to your job? >> we have increased staffing and diversion and have a control coming in. they talk about these issues on the criminal cases and civil cases and how they impact for the criminal prosecution they want to continue to gather evidence and we have some that's being done and we can stop it in a more proactive way. this isn't just a one issue you
fix. >> one of the things i am concerned and want to know more about that's what is going to create the changes by making changes and also to start paying attention whether it is through the computers or personnel cause they can flag all at once to flag that if a human isn't taking those warnings and having action based on then it is just going to be a flashing computer. >> the chair will recognize the gentleman from texas. i want to acknowledge that i asked for you to come to my office this is something about which many of us feel strongly and we want to get some answers.
the subcommittee has interest in knowing about through the differences between voluntary suspension orders and immediate suspension orders. it is a more pernicious path to follow. are there others that you have. depending on going back to the issue you brought up, depending on whether it is a doctor or pharmacy if need be a different reaction than what we would do. >> in the diversion control it is a document against doctors
and this is produced by the u.s. department of justice gets about 100 pages long. it is 300 cases against doctors in the last 15 years. does that sound about right? >> that is a complete list in the guide to help people that got him into trouble. >> what concerns me as i look through this is that most of the dates are before 2009 so my question would be where is the data from the 2010 onward and perhaps that is something we can follow up on together because i share the provider's perspective
we want to be able to provide the relief when it is required and appropriate at the same time we obviously do not want to be jeopardizing public safety. this could be important information that you mentioned at the start as one of the number one problems if that is the case it's this sort of information that is i think are goini'mgoing to be very helpfuls as policymakers how do we develop the correct policy. you referenced $309 million in fine at the level is that correct? so 300 to $400 million.
we appropriated $1 billion for the treatment of this problem and will take another $6 billion in the appropriations that are coming through right now. whether it be suppliers and prescribers causing a problem to exist it is only a miniscule compared with the amount that it's actually costing society to save people and salvage people and get them back to productivity that doesn't even address the fact that again people are taking productivity out of how to become productive citizens when they enter into this type of behavior is that correct?
let me ask you this because they reference 80 people a day that are biting and is at 115 is the total number about 80 per day are dying because of what you described as overprescribing and then we've got these lists that in my observations are not up to date. do we know how many are dying from overprescribing in 2007, 2008, 2009 in that timeframe do you have a figure? >> it was an alarming number even in that time pure cow. >> then that begs the question and again i appreciate the efforts that yoeffort you are pt now, but it's been right there
in front of us for well over a decade and a half and clearly it requires all hands on deck. i appreciate your being forthcoming with my office and i appreciate and will yield back. >> the chair will recognize the gentleman from new york. >> i would thank the ranking member. it's clear in many cases there's some pharmacies in west virginia but we've also seen some data that many were buying from multiple distributors for example in 2009, but west virginia pharmacies received over 2 million opioid pills from six different distributors including over 300,000 from one distributor over 600,000 from a second district leader and over 900,000 from a third so it's bad
enough if one distributor over supplies the pharmacy but when you look at the total shipments received from all distributors, there's about 2 million pills, which is about over seven times what a similar pharmacy would be expected to receive according to their own data, so it's the only entity that can see the multiple distributor sending from a single pharmacy is that correct? >> from this level, yes ma'am. >> arwere they performing analytics a decade ago to identify these kind of patterns of individual pharmacies? >> .in dot reactive manner at the time. >> i would like to look at the date on another pharmacy in west virginia, statewide pharmacy in the small town that receives hydrocodone from five different distributors in 2008. a few distributors providedif yd
relatively normal amounts that don't seem to raise alarms, however one distributor ships 1.2 million pills and another nearly 2 million. how do they try to stay under the radar by buying from multiple dose computers. this is where the critical nature comes in working on this dates the same pharmacies that would show that amount of distribution from those pharmacies so we have been distributed in and then the pharmacy out depending on the program so the key is for us to
work together on that and again i can say repeatedly in 2008, 2009 and 2010 we did not use it in the way that we are now using it and i think that is the key. i get that we have this issue from a decade ago that we have the resolve in terms of how we used it, and again where we fell short and he will take responsibility for that. i think the system is more robust and used in a different way. >> can you give us a little bit more insight into how you are proactively analyzing the data to ensure that they are not being oversupplied by the multiple disbelievers that is not coming across clearly to us. how are you actually doing that disruption? >> as we talked about in the opening, we are proactively looking at the data not just in the database that we talked abouabout but the hhs and progrs
where we are sharing that information looking to proactively target out flyers. >> so, what happened once you've are in this regard, what exactly happens? >> we share that information for the investigators, those divergent groups depending on how they are being used to go out and work the cases to find out is if they legitimate amount of prescriptions that are going there or is there an illegitimate diversion of kerning in those areas. >> and have that worked plus far? you said this was over a decade ago and i'm assuming that you've already begun this sort of new protocol. what are you finding? >> in those 400 packages that went out, a good majority of what we saw in the data in the outliers and will be identified for ongoing cases we already have which shows the data set works to the developing target
in the areas we have problems to the extent we didn't have cases on the other ones and they were warming to be opened them on the facilities were the distributors to take a look at that behavior. >> i just want to share with you that this is an ongoing crisis once we are able to disrupt the supply chain we know that it becomes planted by more nefarious actors and so i really want to impress upon you and your agency to be as forward leaning in this regard as possible because once those pills are cut off, we know that is when the trade picks up in velocity. >> as we talked about again in the opening that shift has already occurred. >> the gentlewoman yields back and we will now recognize the gentleman from new york for five minutes. >> thank you mr. chairman and mr. patterson. you can tell doesn't get out of
jail free card as you've been in the job for five months i would hope five months from now you wouldn't be getting many of these same answers. following up on what was said, i think we are just all frustrated there seems to be the bureaucracy mindset. in the dea today much what we've seen in the va we are finally seeing heads rolling ball as fast as we want, i am just curious because there is no doubt that there was an abject failure going back the last ten years. have a lot had been chopped, do we have a new team in place? >> as i said we have a new head of diversion control. the last two people that have gotten the job have been both successful at turning around program. >> not to interrupt, but i think the right people can turn this around in 48 hours. ina turnaround guy that's what i've spent my whole life doing.
you begin a new team and people get called into the office every day and say someone just hit me upside the head with a baseball bat if i don't get my act together, this isn't a time to be polite or nice or let's do better tomorrow, this is an abject failure if i go back to if i'm sitting in that seat and they processed 1.6 million orders had only 16 were deemed to be suspicious, that is absurd. i don't know what kind of computers you've got, but that is absurd and means no one was watching. if you can say that was being done in the district level but it's indefensible. when we look in west virginia, there are two suspicious workers. maybe let's jump ahead. in 2008, cardinal health was fined $44 million for not reporting suspicious orders.
let's go forward eight years later they are still not doing it. how much do you think you will find years later $34 million, the same amount. in most places the second defense. first offense 34,000,008 years later the same problem it should have been $340 million. what message did you send and if this was a year and a half ago, you guys don't get it. this committee agrees on a lot. i don't think we have ever agreed across the board on an issue as much as we are agreeing your agency needs to be turned upside down not just a shake up here and there, that turned upside down and it starts with you. if you can't do it you ought to get out. when i look at some of the other
things we have distributors and pharmacies. if i happen to live next door literally to one of the doctors in clarence new york and i saw his sports cars parked outside we all know his name in the committee is doctor payne and this wasn't something new, so it took when i look back it took a good seven years to come after and by the way he doesn't live there anymore, but he had set up a script line in 2012 where people could call in and fill with basically no supervision, so at what point, how could you allow a single physician, my next-door neighbor literally in clarence new york to write more prescriptions for opioids than any other doctor or hospital in the state of new york this 20 million people in new york in
my particular town there's about 50,000 people. one doctor in the town was writing more prescriptions than any doctor in a state of 20 million people o in the hospital including new york. it took you five years to figure out that there might be something suspicious? would you agree that that is unacceptable? >> i wouldn' >> i wouldn't have any data on a particular prescriber. >> they seized his cars and bank account. >> so at some point if it was a case i don't know what it was that investigated him. at some point we learned of that -- >> that what's going on with the computer systems and other things it takes four or five years. i mean i i know how computers work, i don't know how old viewers are, but this kind of tf data should be instantaneously
available. >> i go back to the states control of the prescription monitoring program. we control -- >> maybe you should be kicking some butt going down the chain. if i'm in the hot seat right now if you're telling me we should be putting the blame on the state come if we are not looking to place blame, my time is expired and we look forward to you coming back in another four or five month with a different set of answers. >> the chair will now recognize the gentleman from new york for five minutes. >> i want to find out if they use the data gathered through god marco system to gain visibility into how many pill distributors send to a town or region as a whole even if the distributions are spread out over multiple pharmacies.
administrator patterson, a town examined by the committee was williams in west virginia population 3,000. our committee's investigation focused on two pharmacies in the first is the tug valley pharmacy. could i ask that we sho showed t exhibit number three on the screen? >> okay, we have here.org valley pharmacy. according to the narco state between 2006 and 2016, they received over 10 million doses of opioids from 13 different distributors. this includes over 3 million pills just in the 2009. so, administrator, this is an unbelievable quantity for a pharmacy this size in a town of 3,000. do they believe the amount of opioids the pharmacies received was excessive? >> i would say so sir.
>> and again if we could put the minority exhibit number four up on the screen. this is the second pharmacy in williamson that we see on the screen here. the data shows that it received over 10.5 million doses of opioids from 11 different distributions between 2006 and 2016. this includes over 2 million doses goes in 2008 and in 2009. again this strikes me as an excessive amount of opioids for a pharmacy in a town of 3,000 to receive. do you agree this is unreasonable? i mentioned both of these pharmacies are located in williamson and incidentally both of them are still in our petition today. i would like to show you where they are located so if we can post to the minority exhibit number five and combine the
distributorship over 20.8 million doses of opioids to these two pharmacies which you can see on the screen are located only blocks apart and they did that 20.8 million doses of opioids between 2006 and 2016. between 2006 and 2016, what kind of data analysis did they do to alert with distributors shipped an unwarranted amount into a town or region so that it could stop these excessive distributions? >> again i would have to go back and look at that specific example anthe specific examplean terms of where those periods of time where as i already testified previously we used the data in a very differently today than we did then, but i would
want to go back and look at the timeframe and what was going on and then i can get back to you on that. >> if it were used today, would it have avoided something like this? >> i hope so. can we have a little more of an answer? >> part of the important issue that we are talking about today is to go back and look at the specific examples. i've seen examples where we actually can't see some of these tamales, so i think that in taking these examples back and using a timeframe of 2006 to 2016 i can tell you the last couple of years with the data has been as i sit here, traditionally what we have seen is very high levels of distribution into those places between 2008 to 2010 or 2011
when we start to look at the data in different ways. still not as proactively as we do today but that is why i would like to take the example back. >> i've been dealing with this issue a great deal in my district and when i hear of opioids being the gateway to addiction is very disturbing and the heartache and pain and death associated with that illness is a crisis and we need to do something very valuable here and i would end for her that the fot the bea would be smarter in their approach and with that i won't yield back. >> the chair recognizes the gentleman from pennsylvania for five minutes. >> are you aware that the chief author reports describing the declining use as noted in
june 2014 and alarmingly low rate of aging the papers and enforcement activity on the national level? so the last several years they reported the declining number to the administrator on a quarterly basis and this issue has been raised in the committee's investigation my question why has the number declined significantly over the past few years? >> two things when you look at those statistics. although it is warranted, the statistics were very high in 2010 and 11 because of the issues we were dealing with in florida and how they were being used. during this latter part, we've gotten to the point of trying to expedite the surrender of registrations we have much more going in to try to get voluntary surrender for the cause orders. >> is there still a need for a as there was for the enforcement tool? >> yes. >> the report state stated the f
counsel had, quote, instituted a new batting initiative that could be slowing the progress of the cases what was this initiative? >> i don't know if it was initiative for guidance. >> what was the guidance? >> it was directed towards distributors not necessarily directed at doctors and pharmacies. >> have you provided that guidance in full to this committee backs >> we have not. >> that is a conversation we have had and we will continue to work for. >> when the state revokes a medical license the doctors no longer eligible to have the registration associated with that license i is that correct when the doctor no longer has the authority to prescribe they have to conduct any further investigations or can they execute the registratio registrt obtaining the certificate of the medical license revocation? >> we can do in order to show cause.
they lost to state authority. >> after the medical license how quickly are they notified and how long does it take to revoke the doctors registration? that's where we need to be working with the states to learn that the state medical boards are the field office is responsible. >> are the majority of actions and litigation cases comprised of these no state authority cases that do not involve the investigation? >> that is correct. it is estimated to be about e.% of their actions? >> that is a fair number. >> i would like to yield the balance of my time. >> when i was asking questions earlier, the requirement for political expert advancing and the fact that that would take a
number of weeks and you said 45 to 90 days and i went through the different steps that would lead to that. so you agree the mission to protect the public safety and there's a tremendous amount of delay and part of that in no small measure is the requirement that before you get that administrative tool, you have to get a medical expert. so can you as the acting administrator agree with me today that you would be willing to re-examine the expert requirement and i appreciate that. >> we are using the word requirement into the art in reference to distributors and not the doctors and pharmacies but i would be happy to go back >> that's okay as long as we are working it out we want to make things better.
where the drug stor that drugstd anybody with any sense knows that they were coming into my district and likewise i had some additional questions that dealt with the fact that we had problems with red flags being raised and picked up on so we had a doctor in the county sending his patients over and we have a situation in martinsville where they have according to the cdc they provide more painkillers than anywhere else in the u.s. per capita in another doctor was prescribing opioids for the patients in north carolina, so i look forward to solving these problems but they are real-world problems and i yield back and now recognized congresswoman
walters. >> it is my understanding that they often use tips and information received from state and local law enforcement to develop the cases against entities or individuals suspected of engaging in or facilitating illicit drug diversion is the perfect? they provide the agency with retail level data regarding the controlled substance transaction. does this mean they can show many doses of hydrocodone in the individual pharmacy received in any given year? as a part of its investigation the committee has obtained and analyzed the data to a great effect so we recognize how important that can be. in february of this year they announced they were adding a feature that would allow the manufacturers and distributors
to view the number of companies that have sold it particular substance through the first prospective. does this policy enabled companies to seenable thecompanf controlled substances to customers are receiving from other suppliers? the >> part is knowing that customers know when to buy all these concerns. >> does the newly added feature provides state and local law enforcement with greater access to the retail level data? >> when we work investigations with the state and local level, obviously we can share the data as a point of investigation and this is part of the issue that we are dealing with the states attorneys generals to be more proactive. >> according to a letter sent to the committee in november of last year by the dea will share
data with law enforcement on the need basis when they are operating in coordination with the purposes so is it fair to say the state and local law enforcement entities don't have access to the dat that data on a real-time basis? are they developing any proposals that will enhance the state and local abilities to access and utilize the data? >> again we are working jointly with them into this goes back to the efforts of the states attorneys general. >> for the opioid epidemic, we need an all hands on deck approach. they have data that could assist the drugs in the communities and i think that it should be exploring every avenue to pursue this to law enforcement as quickly as possible.
it seems to me providing state and local data would be beneficial. mr. patterson, will you commit to examining the ways for local law enforcement access to the data so the bad actors might be able to be identified with greater frequency and effectiveness? i yield back the balance of my time. >> i now recognize the gentle lady from indiana, ms. brooks. >> since 2011, the number of orders issued by the dea as you noted declined significant from the high of 65 in 2011 down to a low of six and 2017 so i want to talk about that a little bit. are there instances in which they pursue in immediate
suspension order that is in parallel with related investigations? >> since october, the issue that i traditionally seen as because of the process of where the criminal case is being investigated there's been a delay in the iso process of gathering evidence. it goes back to again with mr. griffin says that cuts against the argument that we have an eminent problem that we are trying to deal with, so the conversations i've had with the attorneys is we have to act much fact -- faster and if we have the ability to stop the harm even at the peril of a criminal case that is what we should be doing. >> the attorneys don't do the needed suspension orders, those are done by the dea.
are you saying that the u.s. attorneys were asking as a former attorney are you saying that they were asking or telling them not to issue these? that can take months if not years, but do you believe that is what happened prior to you coming in in octobe and octoberd if it happens? >> i think that it's been an ongoing theme of what some of ththewith some ofthe delays are. >> and why would they delay tht type of administrative action. >> people believe the criminal investigation is an important endeavor to the doctor or pharmacy. >> it is important no doubt because that person is obviously distributing illicitly. why would an immediate
suspension is that so that undercover operations can have been with the physician? >> the gathering of evidence. >> what is the new guidance, i appreciate the gathering of evidence but what is the new guidance relative to these in the criminal investigations you are contemplating or that are in place now and is it in writing? >> i served on the advisory council gave >> to the extent they try to talk to them about the same issues again a lot of this is striking a balance. a lot of them is to get contemporaneous evidence undercover as opposed to using
witnesses that have come in and don't have the best of backgrounds. i understand that and the concern i have come it feels awful we are to be signing that a year after we learned of the problem serious >> i noticed in the document there was some of that a year after the arrest. although the time of the arrest, that individual would be under the medical licensing procedures as well as the correct? wouldn't it make more sense to implement in the middle of the investigation because it can take months if not years and in the meantime we have got all these people dying. >> even in the absence, on my concern is why aren't we trying to get a voluntary surrender and we have a lot of offices that do
that in a very expeditious manner. >> will they propose a cap on the length of time it can be delayed is that the kind of discussion you are having like 30 days or 45? >> they will probably always be the exception that comes up and as long as whether it is a u.s. attorney or state attorney putting in writing why we need the delay we can evaluate that. the process itself we have to work through and we have a new diversion that has been bothering me greatly since october i see newbies and generally i have the same question every time which is why are they taking so long. >> when i became an attorney in 2001 it was against doctor randolph for overprescription and they said prescription drugs were going to be the next crisis in this country.
it didn't start in 2010 or 2011 but it was in 01 and 02 we had a focus during the period of time and it's been devastating to see that we fell off of that commitment. i yield back. >> the chair will now recognize the chairman of the full committee. >> i appreciate the intelligence of the committee. you've raised an interesting issue in saying to the dea stop we want to proceed in the criminal investigation. one question did they have the authority to override the authority, and then i want to know the who, what, when, where and why are the attorneys that interceded on the cases and in what areas and told them to suspend, and do they have that authority because people
continue to die during this period. idoes the u.s. attorneys office has the authority to talk you don't do the iso because we have to investigate which will have a bigger penalty which i respect, but is it one agent somewhere, one attorney in west virginia they went off the rails and so i would like you to get back to the committee with answers to those questions. >> i would be happy to do so and i can assure the committee this is a topic that we have had some robust discussion on weekly as we've gone through to also assure you the direction of the administration is to stop them as quickly as possible. >> do the u.s. attorneys have the authority to overrule the
decision making? >> we could issue even against the wishes of the u.s. attorney or state attorney is probably doesn't hav help relationships o take those actions that i think this is a part of the education of us holding these things up on the criminal or civil actions. >> i would go back to the analogy if you are driving down the road you don't wait until there's a fatal accident to pull them over and stop them. you can prosecute them along the way and it would make the case going backwards as they've been returned. the two pharmacies we've raised months ago my understanding is that it's still operating in west virginia. they are not operating. okay. if you can get back on the who, what, why and when thank you. >> the chair will recognize the gentleman from georgia for five
minutes. >> i suspect you know i'm the only pharmacist serving in congress and ms. brooks makes the poin point this isn't sometg thathat this isn'tsomething tha0 or 11 was going on in 2002 i was practicing back then and it's probably been four or five years but i still know what's going on out there. we have been nibbling around the edges and there've been great questions that i want to follow up on the questions that the representative asked about the beginning of where the problem starts. i'm not naïve enough to believe there are pharmacies out there that are in collusion with doctors and filling fraudulent prescriptions but i want to talk about those that are writing prescriptions and are obviously out of control and why it is taking them so long to get them in control were under control.
i will just give you an example i served in the legislature for ten years and sponsored the legislation that created the drug monitoring program. .. >> 180 with three prescriptions she gave me her driver's license from florida. i said i am not filling these prescriptions and then she drove off with kentucky drivers license i will not
fill those msi have a legitimate prescription. okay? i didn't want to but i was in the position where i had to judge if that patient was legitimate. i am not trained in law enforcement as a pharmacist but there are doctors out there writing these prescriptions why can't you get them quicker? he is right you should turn that around in 48 hours. the first time i had that prescription i knew something was wrong. i had an example i went home one-year ago and the pharmacist was telling me go to doctor b. we didn't fill prescriptions for five years but he kept writing them. they got him for medicare
fraud. they never did. that is another example. doctor thousand literally thousands addicted to these medications that goes before the medical board to get slapped on the wrist and they make him practice under the supervision of another doctor that is his penalty now he is practicing from the waterfront with a beautiful home but now thousands of lives are addicted we wouldn't fill those prescriptions so tell me why it takes you so long to get to the alpha or the beginning or the doctors who are out of control? explain that to me because i don't understand it. you just have to say what do you not fill four? the pharmacist will tell you we don't feel for this doctor.
>> that is what we have to rely on. i will not shift blame anyplace. >> but that is what you are doing because you can turn this around in 48 hours. >> but in the cases of these doctors to do reviews we ask for information to solicit people to essentially to come talk about the restaurants they have problems with it that doesn't happen then somebody who has been arrested in a criminal cas case. >> you can imagine our frustration literally four or five years they can end this. >> we understand this is where data becomes critical. >> so what can we do to help you to get these doctors under control? >> it really boils down to data.
>> that you have had that since 2009. >> we do not have access to that data. >> and dea shut that down or set the medical board? >> we had someone that was showing us the doctor was overprescribing. >> but don't you know when you get this information? you know the pharmacy fills the prescriptions from somewhere. that ought to be an indication we need to go to that community to find out what is going on. >> understood. >> thank you mr. chairman. >> the gentleman yields back we recognize the gentleman from west virginia for five minutes. >> thank you mr. chairman i appreciate you giving me the opportunity as not a member of
this community and thank you for being here. are you familiar with the book called american pain? >> no sir. >> this is about the clinic in south florida the center of the opioid crisis i would suggest that you read that book. but with all due respect to some of your testimony the way it has gone he could assemble this without access to arcos but he could put it together to demonstrate he has a clinic in south florida with two
times the medicine and the state of ohio. and he is not an agency with all the resources you have also putting together all of those combined. nine times the amount of pain medicine from every state in the country. he did that longhand with all due respect i don't thank you can hide behind the fact you don't have the resources because it was done manually but i am curious about the production because in the book he talks about the speed pills in the 70s were a problem. and the dea stepped up to cut the production by 90% and the problem went away then in the 80s we had a problem with quaaludes. the same thing they cut production and it went away.
now fast-forward to today are what we have in dealing with the last ten years with opioids, we continue to increase production and distribute those. didn't we learn anything from our past experience we should cut back? not until 2017 when we had the first reduction but still 50% more than ten years ago. how do you respond to that? did you learn anything? >> the quota numbers unfortunately are to ensure access to the patient's and you can see the trend as the industry said more more people needed these prescriptions. we worked aggressively the last year and a half to work on the issue i give a lot of the credit to the state. >> if i could, i think perhaps i know you are meaningful and trying to correct it but i'm
coming from a state that has 52 drug overdoses per 100,000 people we are leading the nation know you have the ability to transfer resources and funds within dea so my question is have you made any transfer back or will you put more resources into west virginia as a result? >> we have and are continuing to do so. >> about a year ago you put a tactical diversion squad living that is the second is that correct? >> correct. >> leading the nation is that sufficient do you thank you have diverted enough attention into west virginia you don't need to divert anymore? >> the creation of the louisville division has three states are all struggling with the same problem tennessee west virginia. >> i'm sorry i'm just dealing with west virginia that is the
epicenter. it has been there nearly ten years at the highest level and we have not seen resources come into west virginia and i appreciate it very much putting the diversions into clarksburg but i think a lot more attention needs to be put into that because of peak can do this longhand i thank you can do it with your resources into far better job to save a lot of lives so i am asking you to please look at more diversion of some funds and resources with this situation. >> yes or we are working on that and are continuing. >> so what are the optics? how can i measure if you are successful what you are doing? because last year in my county we artie had a 50% increase over dose death in west virginia. how do we measure this? will we see a drop next year?
>> the concern is to see a shift from other illicit substances but the goal is to drive down the prescription rate and the diversion of the prescription pills. >> what are the optics? will i see a decline next year ? >> a hope we see declines across the board some states will take longer than others. >> i yield back. >> the chair will recognize the vice chairman for a follow-up question. >> i appreciate it. ms. brooks unfortunately had to step out. due to the medicaid fraud control unit to those still exist? >> i have to find out. >> she was indicating his these particular dues growing after medicaid fraud for
overprescribing and that is a collaborative you you should be looking at various states to figure out who those robed doctors are in that regard as well. moving on, can you explain how the dea volunteer registration is effective as the iso if it takes years as in the case in the permit west virginia? >> i need to get the facts but the voluntary surrender probably came as a result of the criminal case. >> so you would reverse that over to have voluntary surrender? >> again i cannot necessarily go back why certain people did certain things. >> but going forward you do. >> absolutely.
>> you mentioned prescription drug is a tool to combat diversion how is the dea currently utilizing that data? >> this varies state to state but the concern is our access to this data and how we can access the data. >> so this is one of the big conversations we have had with the 48 states with these two coalitions. >> you also mention access to the data that you just told us so what is the dea doing to address those concerns and the actions of the agency currently faces? >> we are looking -- working with all the states individually to leverage the coalition in a perfect world we have a federal process we
can take the data to put together at a minimum the states should be able to share this data with each other. >> are there other areas we could improve the process? >> again that is the key piece. >> i appreciate it. >> just to give you an update i will look -- have follow questions and then we will be done so now i recognize mr. carter. >> i will be very brief i just want to follow-up you are correct you cannot do anything what happened years ago but you can do a lot what is happening now. so what is happening with the wholesalers when they are preventing the pharmacies from getting a certain amount of
drugs that has the best of intentions sometimes that causes them not to get what they need so please be careful with that there are patients out there and hospice patients who truly need these medications. we found ourselves running out from the wholesalers because we already used up our own -- limits that is a precarious position it is not a good position but it is a very bad thing for pharmacists to go out to say this patient doesn't need medication. who am i to say that that this body pierced person is not in pain? that's not fair we have to make sure we get this under control to still maintain tell me what i can do to help you to give you the tools that you need to react quicker to get under control when they are out of control just tell me
what you need because i promise i will do my best to get you those resources see you can get the rogue physicians not all of them but some of them but some of them are out of control and it happens quickly. >> thank you. >> the chair will recognize the ranking member for concluding question. >> this is a rough topic and we know you haven't been there that long but we also know that it is urgent we get this right for the safety of our constituents so a couple of areas to clarify asking questions about the settlement the doj had with some of the distributors with issues of
suspicious orders and it is important they report the suspicious orders to you because you cannot do your job unless you get that support. >> absolutely. >> the doj has reached two settlements in 2008 agreeing to pay $34 million to resolve allegations it shipped large quantities without reporting to the dea then in 2012 again cardinal agreed to pay $44 million million dollars to resolve a similar claim. do you know broadly speaking by the department of justice decided to take these cases? >> i don't from the documents i have seen from the 2012 case that the mo a essentially they were violated again so that is
probably the basis. >> so now similarly reaching two agreements with the doj to pay $13.5 million again 150 million in 2017 to resolve allegations it failed to report suspicious orders is that the same situation we talked about? >> yes ma'am. >> if those are a key part to prevent diversion the distributors are the manufacturers are key. >> know if the distributors fail to support those on -- report the suspicious orders that undermined your ability. >> yes. >> following up you are asked
about, but on this website you were talking about that you have for distributors to look at, it lets distributors see if other distributors are providing to these pharmacies but it does not tell volume. is that correct? >> i believe it does i believe it shows a six-month window. >> i think so because it is my understanding the distributors are looking at volume. >> no volume. >> i can understand what they are saying about that with trade secrets but the problem from my perspective is if you
just say we have a website to see if other distributors are providing in that area if you don't know the volume then it is hard for somebody to see if abuse is going on. >> yes ma'am. >> we should probably talk about it maybe you can supplement your answers because just knowing if other people are going there i don't think that will solve the problem. >> i yelled back. >> for clarification in 2008 cardinal paid civil penalties and again in 2016 and $10 million was paid through a subsidiary if that clarifies that. through our investigation the committee has learned in order to do that almost daily
suspicious orders which are received millions of opioids through the pill mill physicians like mr. collins neighbor that he referenced those remain in operation and it is unclear to what extent the dea followed up on those reports it received so tell us what is the process when evaluating suspicious order reports and the actions it takes to respond? >> they are reviewed at investigation to bring this into the headquarters process some of these companies have districts throughout the country why we went to look at those see if it is a corporation not just individual entities so that is a change we are doing i have to look back on specific issues of any database but i
think that id centralization we have had structural problems how we use not just some of this information but we are rapidly trying to get a handle on these with these reports because we need them. >> you have discussed implementing that process suspicious orders to dea headquarters have they identified breakdown of that process in the past and what corrections or adjustments? >> how we look at these things with the accountability when we get these reports is one of the big changes that i have
had conversations with all staff in the space whether the alj or the chief counsel that we essentially have to do what we are supposed to be doing each and every day. >> when you make decisions that dea headquarters personnel at the headquarters probably have field experience at some level is that a fair assessment? >> that's correct. >> you're also taking into consideration those in the field now to get their input with boots on the ground? >> it is a portent i really only have done this for the last 15 months and deputy but fresh sets of eyes are critically importan
important. >> we have talked about prevention and education and treatment and your role is enforcement and prosecution in laying the groundwork for the problem that we see as we look at this in great detail is law enforcement does not have the capability to take care of this issue that is why you see many of these cases coming out of rural areas certainly we want to make sure to take care of the rule areas as you look at that. there were a number of times that you referenced i will get back to you or get that information so just know we will be looking for that. we should be able to work together on this and note we are not happy as the chairman
of the full committee hadn't even called for a press conference we want to make sure the things we need to know or inquire or what you have for us to prefer more openness between the committee and with that we thank you for your time today it turned into a long time but it has been helpful for us and we will look for to the following questions thank you to the members who attended and participated today and i find members they have ten business days to submit questions for the record so please see that those are responded to promptly as you receive those and we are adjourned adjourned.