[gavel banging] welcome, everybody, and thank you for your attendance, particularly those who have to testify and answer questions for us because i know you put in a lot of extra work to be ready for it. This hearing is on the oversight of a bill that has a long name called insuring Patient Access and effective Drug Enforcement act. Now somebody is going to have us pronunciation for the acronym. Im not going to. Im going to refer to as the law and the bill. Some would like to see this law repealed. Others insist that it should remain in place. I havent made my mind up on that issue. So i am interestedn hearing both sides of the argumt. This discussion is particularly important giving the continuing Opioid Epidemic that has ravaged this country through the past several years. I do have concerns with how we got to where we are today and the discussions that were having today. When Congress Took this bill up in 2015, and 2016, there was little, to no fanfare about the proposal. The basic goal of the bill seemed very modest, provide a definition for the term, imminent danger. Distributors and other providers would have more clear guidance for what was required of them before dea could issue an immediate suspension order called iso in this industry an iso can be a death sentence. From their standpoint the clarification seemed not only fair but a necessary step in helping figure out how to comply with the law. There was another practical concern, that of ordinary patients with legitimate needs having access or losing access to essential prescriptions if legitimate distributors were shut down. Dea understandably had some concerns about curbing their Enforcement Powers but unlimited, undefined Enforcement Authority needed some refinement. Dea also had litigation risk with such undefined authority. So dea too had an interest in working towards amending the language to reduce their own risk. My understanding was that dea provided Technical Assistance to both house and senate staff for other members who were responsible for drafting the bill. In fact, dea admitted as much in testimony before the house representatives october of this year. When the bill came to the senate it was referred to this committee. I took up the bill based in part on assurances from dea and the department of justice that they agreed to the language in the final bill. We discharged the bill from committee. We did that by unanimous vote. The bill then passed the senate by unanimous consent. It also passed the house by unanimous consent. President obama signed the bill into law april 2016. Dea testified that they had advised president obama to do just that. So let me be clear. If dea or the department of justice didnt want this bill, i wouldnt have taken it up, period. Then the Washington Post and 60 minutes ran pieces criticizing the new law. Both stories highlighted former dea employees and quoted a law review article from the acting chief Administrative Law judge for dea. The reports in the media suggest that congress was in the back pocket of the opioid industry, and that this bill was a giveaway to the Prescription Drug industry. So as i have described it should be fair to everybody to see, fairly clear to everybody to see that nothing could be further from the truth. I have worked hard my entire career trying to combat illegal drug trafficking. My friend here from california and i have worked together on a group called the drug caucus, to do just that, besides the work we do on this committee. We did it to provide more effective ways for Law Enforcement it do their job in the Drug Enforcement area. Im especially frustrated by the dea itself, which Gave Congress the go ahead to enact this legislation. We wouldnt be here today if the dea told us they objected. The news reports also suggest that the law effectively stripped dea of its enforcement power. The data appears to show otherwise. Prior, in other words, the data shows this, the, prior to passage of the bill, between the years 2011 and 2015, the amount of immediate suspension orders dramatically decreased since the law was passed, the amount of the immediate suspension orders has increased. Moreover, the number of opiates distributed overall decreased between 2016 and 2017, which all comes after passage of the bill. Dea has said that the law, quote, did not stop dea from doing its job in in the diversin space. Even though this bill was vetted by congress once, we all have to be open, at least im open to reexamining the criticisms of the law and hence were here. Im looking forward to the hearing what those are. In other words, what the criticisms of the law are. But we shouldnt be repealing laws just because the loudest person in the room, and solely based on one persons sayso. The dea agent who was the center piece of the news article is a consultant for trial lawyers for suing the industry. So his objectivity could be questioned. The sensational news stories failed to question this conflict of interest. I look forward to hearing the testimony from the witnesses and finding new ways to strengthen our Law Enforcement efforts without preventing legitimate access to medications that real patients with real legal prescriptions need. Opioids continue to be a huge problem if this country. It is vital that our federal laws keep up with the best way to combat illegal opioid use. Before we start, i have a prepared statement from congress manage tom marino, author of this legislation, original cosponsor of the bill and he introduced the house version. I have a statement from congressman tom marine yo that im going to enter into the record without objection. Now senator feinstein. Thanks very much, mr. Chairman. Im very disappointed that neither the dea nor the Justice Department would allow dea chief Administrative Law judge mulroney who wrote a law review article that was critical of this law to testify. In that regard im going to put in the record a letter dated december 12th from an assistant attorney general who didnt bother to sign it himself and i cant make out the handwriting of the person who did but essentially saying we have other people and they will not make him available. First time in 25 years ive had this kind of thing where somebody we wanted to be a witness was not permitted to come before the committee. Today we are confronted with three indisputable facts. One,ere in the mid of an Opioid Epidemic, the likes of which this country haser seen. Two, we have a collective responsibility to better address it. And three, clearly, Law Enforcement cant keep up with it. Recent news reports claim that this bill, which was enacted in 2016 is partially to blame for this struggle. The law does four things and let me point them out. It outlines the conditions that must be met by drug manufacturers and distributors in order to obtain a dea registration. Two, it defines whats, quote, imminent danger to the Public Health or safety. End quote. In doing so, it lays out the circumstances under which did. Ea may issue an order to show cause. An immediate suspension order or revoke a registration. These circumstances were not previously defined, which left registrants unsure when dea might ache action against them. This point was underscored in the 2015 gao report which made three recommendations to dea how to improve communication with registrants in order to insure. Third the law allows registrants to submit a corrective action plan prior to dea suspending or revoking the registration. It also stipulates when an imminent danger exists, dea may immediately suspend a registration. Even if the registrant submit as correction action plan. Finally, the law required by the department of health and Human Services to report to congress on how Law Enforcement can better collaborate with the pharmaceutical industry to increase Patient Access and prevent drug diversion. The department is eight months late in submitting this report, and it has failed to respond to the inquiry the chairman and i made about it. Data provided by dea does not seem to support the argument that this law has hipped dered its enforcement efforts. To the contrary it shows that dea Enforcement Actions, while now starting to increase, pebegan declining well before law is enacted. Between 2011 and 2016 immediate suspension orders filed against pharmacies went from 21 to four and those filed against practitioners went from 43 to five. The last time an immediate suspension order was filed against a manufacturer or distributor, and this order immediately stops the distribution of pills was guess what . In 2012. Between 2010 and 2016 Civil Penalties leveled against distributors dropped from 3. 1 million to a mere 115,000. Sounds to me like something isnt working. So during the same years that we saw opioid Overdose Deaths increase by 57 , deas Enforcement Actions in many categories substantially declined. What i want to know is why . Something isnt working. It needs to be fixed. If it is not the law, and i have asked dea and the Justice Department for their assistant assistant assistance in looking at the law then we need to figure out where the problems lie. Ive been struck by the examples of negligent distributors raised in recent hearings and round tables. Let me give you an example. In a twoyear period nearly nine million opioids were delivered to a single pharmacy in West Virginia. Nine million pills to a single pharmacy in a small state West Virginia. Further, between 2007 and 2012, distributors delivered 780 million oxycodone and hydrocodone pills to pharmacies throughout that state. The result . A reported 17 billiondollar profit for distribution companies. And heres the price. 1728 fatal overdoses over six years. 1728 fatal overdoses versus a 17 billiondollar profit for distributors. Consequently many distributors faced and settled lawsuits with the state. Yet almost all of them maintain that prescribers, pharmacies, and Law Enforcement are better situated than they are to prevent diversion. It is hard to imagine a circumstance under which a request for nine million pills to a single pharmacy, or 780 million pills to a single state would not set off warning bells to those distributing them. In my judgment there was no excuse for the continued shipment of these drugs. The regulations promulgated by the controlled substances act require manufacturers and distributors to conduct Due Diligence of their customers. To detect and disclose suspicious orders to dea, and to keep complete and accurate records relating to the manufacture or distribution of controlled substances. It may well be that dea nodes to issue more guidance as to what constitutes a suspicious order thesexamples illusate the fact that some distributors appearedo be more concerned with their bottom line than fulfilling their responsibilities under this law. Bottom line, we cant turn a blind eye to this kind of reckless disregard. And Law Enforcement must actively pursue these kinds of cases. With that i look forward to hearing from our witnesses about how and whether this law should be modified. We can not continue, ladies and gentlemen, to lose more than 33,000 americans each year to an epidemic thats entirely preventable. Thank you, mr. Chairman. I want to associate myself with the disappointment that senator feinstein expressed that the witness we asked to come was denied coming by the administration. And today we sent a letter to ask reasons why because we didnt get proper justification. Of course now writing that letter doesnt do any good except to give justifiable reason if they have one, and i doubt if they do. If it is okay with my colleagues, i want to call on senator hatch before i introduce our witness because of his leadership on this issue. So would you proceed senator hatch. Thank you, mr. Chairman, for holing this hearing, allowing me to make a statement. Too often in this town narrative gets ahead of facts. A newspaper prints explosive heading it is off to the races. Doesnt matter what the actual facts are. Bandwagon starts rolling and Everyone Wants on or off as the case may be. Mr. Chairman i was dispriced how everyone was running from the bill the moment negative news reports came out from senator mccaskill, to senator manchin, to attorney general sessions seems like everyone tried to wash their hands of it, but no one ever told me they were dubious about this bill when it was going through. No one enter ad statement of opposition into the record or offered an amendment to change the bill. To the contrary the bill passed this committee by voice vote and passed the full senate by unanimous consent. So these last two months have been deeply frustrating to me, mr. Chairman. I wish some of my colleagues would stop trying to rewrite history or pretend this was some sort of shell game. Thats why im glad were holding this hearing today. I want to talk about the facts, the facts of this law, the facts of my involvement and this committees involvement and the facts of the laws impact. Lets start with the i impetus r this law. This law came about not because i or anyone else got some giant check b because of very real ncerns that the way dea was operating was threatening Patient Access. Representative marino said he became involved after meeting with a Community Pharmacist in his district who was, quote, having so much trouble obtaining prescription opioids, that he had to turn away legitimate patients, unquote. I heard similar concerns from constituents. One of whom who will be testifying today. It wasnt just utah and pennsylvania. Across the nation pharmacies were facing supply chain problems. January 2014 survey by the national Community Pharmacists Association Found that 75 of respondents had experienced three or more problems would stop ship. S in the previous 18 months. A majority had to turn patients away as a result. News reports from indiana to florida detailed stories of legitimate patients who were having significant difficulty obtaining needed medication. No doubt these supply chain problems had multiple causes but deas activities were a contributing factor. According to a 2015 gao report the lack of clear guidance from dea to distributors what cons stouts a suspicious order and what can trigger an enforcement action was leading many distributors it place quotas on drug shipments to pharmacies, a practice the report found can quote, negatively impact patients access unquote. The report detailed how fear of Enforcement Actions coupled with lack of Agency Guidance was leading distributors to decline to fill orders even in cases where a distributor had no evidence that a pharmacy or doctor was engaging in diversion. It wasnt just a lack of guidance. I have had a number of individuals tell me that deas attitude towards registrants during this period wasdown rite antagonistic. I have a letter here from a vcu professor that describes some really troubling conduct by diversion control agents and that explains how difficult he found it to work with the agency in good faith. It wasnt just the private sector having difficulty with dealing with dea either. In 2015 separate report about drug shortages, they described great difficulty getting information from deas office of diversion control. According to the report, completion of gaos work was quote, delayed significantly because of deas refusal to comply with gaos request for information for over a year, unquote. Only after the intervention of quote, senior doj management officials, unquo was gao able to obtain the data it was seeking. Insuring Patient Access and effective Drug Enforcement act was an effort to respond to these problems, to provide clearer guidance for supply chain members and to encourage greater cooperation between dea and the requested community. Thats why it defined agencys immediate suspension Order Authority and thats why it provided for corrective action plans. This wasnt some effort to help Drug Companies to kill people. Give me a break. This was an effort to insure that deos praise worthys efforts to stem abuse dont end up hurting legitimate patients. Id like to just say a word about how this law came together. Want to be clear right at the outset this was not a pharma bill. Dont tell me i did this bill because pharma donated however much money to me. Prior to introductions senator whitehouse and i negotiated with dea distributors and Patient Advocacy groups. We may have talked to a Pharma Company at one point or another but they were not key players. You know what . The bill senator whitehouse and i introduced doj was okay with it. They said so in writing to this committee. Of course legislation is a process and aft intduction i thought it was necessary to make changes in order to move the bill forward. I would have preferred not to but we all know that legislation requires compromise. So i had to accommodate some requests from industry sheikh stakeholders at requests of other members of this committee. I negotiated changes with dea and doj in fact the department of justice gave me the substantial likelihood language that critics seem so fixated on. Once dea and i came to a point where we agreed on a path forward i asked the chairman to put the pull on a markup. I kept my end of the bargain. I told other members that what dea had asked me to tell