Washington, DC—This morning, the Senate Judiciary Committee held a hearing to review the Ensuring Patient Access and Effective Drug Enforcement Act—a bill that was passed in the previous Congress to clarify the Drug Enforcement Administration’s enforcement authority with regard to the medicine supply chain.

The legislation, sponsored by Senator Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), addressed a flaw in the system that gave the Drug Enforcement Administration’s (DEA’s) Office of Diversion Control undefined authority cut off prescription supply chains without warning, thereby threatening access to lifesaving treatment.

 The benefits of this proposal were almost entirely overlooked in a one-sided Washington Post report that misrepresented the law’s intent and the process by which it was passed. The same report additionally downplayed the overwhelming bipartisan support for the bill, which passed Congress with unanimous support and was signed by President Obama on the advice of his own DEA.

In setting the record straight, Hatch noted that the very phrase that the news report claims “gutted DEA’s enforcement authority” actually came from agency lawyers. At today’s hearing, Hatch and other members of the panel had the opportunity to ask Demetra Ashley—the Acting Assistant Administrator for Diversion Control at DEA—about the bill’s impact and to rebut claims that the bill has impeded DEA’s ability to do its job. Senator Hatch also took the opportunity to explain the pressing need for the legislation, a key point that has been lost in the one-sided reporting on the bill.

Senators Hatch and Whitehouse Set the Record Straight on their Legislation Clarifying DEA Rules

In subsequent questions with Senators Hatch and Whitehouse, Acting Assistant Administrator Ashley made clear that Senator Hatch and Senator Whitehouse’s legislation had not caused a decline in DEA enforcement efforts. [VIDEO] Click here for copies of the two charts Senator Hatch referenced in his questions. [LINK]

• Senator Hatch has previously addressed flaws in the reports about this legislation on the Senate floor. [VIDEO]
• Numerous media outlets have likewise pointed out a number of omissions in the reporting on the bill. [LINK]
• Patient groups have also written in to express support for the legislation. [LINK] [LINK]
• In addition, a VCU medical professor has described some of the problems at DEA in the years leading up to the bill. [LINK]
• Hatch wrote an op-ed in the Washington Post correcting a number of errors in reports about the bill and its impact on DEA’s enforcement capabilities. [LINK]
• Representative Marino, the House sponsor of the bill, submitted a statement at the hearing explaining the need for the bill. [LINK]

Senator Hatch’s full remarks, as prepared for delivery, are below:

Thank you, Mr. Chairman, for holding this hearing and for allowing me to make a statement.

Too often in this town, narrative gets ahead of facts. A newspaper prints an explosive headline, and it’s off to the races. It doesn’t matter what the actual facts are. The bandwagon starts rolling, and everyone wants on, or off, as the case may be.

Indeed, Mr. Chairman, I was both surprised and disappointed by how quickly everyone seemed to start running from this bill the moment some negative news reports came out. From Senator McCaskill to Senator Manchin to Attorney General Sessions, it seems like everyone’s trying to wash their hands of it. But no one ever told me they were dubious about this bill when it was going through. No one entered a statement of opposition into the record or offered an amendment to change the bill. To the contrary, the bill passed this committee by voice vote and 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.

That’s why I’m glad we’re holding this hearing today. I want to talk about the facts. The facts of this law. The facts of my involvement and of this committee’s involvement. And the facts of the law’s impact.

Let’s start with the impetus for this law. This law came about, not because I or anyone else got some giant check, but because of very real concerns that the way DEA was operating was threatening patient access.

Representative Marino has said that he became involved after meeting with a community pharmacist in his district who was “having so much trouble obtaining prescription opioids that he had to turn away legitimate patients.” I heard similar concerns from constituents, one of whom will be testifying today.

And it wasn’t just Utah and Pennsylvania. Across the nation, pharmacies were facing supply chain problems. A January 2014 survey by the National Community Pharmacists Association found that 75 percent of respondents had experienced three or more problems with stopped shipments in the previous 18 months and that a majority had 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 DEA’s activities were a contributing factor. According to a 2015 GAO report, the lack of clear guidance from DEA to distributors on what constitutes a suspicious order and what can trigger an enforcement action was leading many distributors to place quotas on drug shipments to pharmacies, a practice that the report found can “negatively impact . . . patients’ access.” The report detailed how fear of enforcement actions, coupled with lack of agency guidance, was leading distributors to decline to fill orders even in cases where a distributor had no evidence that a pharmacy or doctor was engaging in diversion.

And it wasn’t just lack of guidance. I’ve had a number of individuals tell me that DEA’s attitude toward registrants during this period was downright 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 try to work with the agency in good faith.

And it wasn’t just the private sector that was having difficulty dealing with DEA, either. In a separate 2015 report about drug shortages, GAO described the great difficulty it had getting information from DEA’s Office of Diversion Control. According to the report, completion of GAO’s work “was delayed significantly because of DEA’s refusal to comply with [GAO’s] requests for information . . . for over a year.” Only after the intervention of “senior DOJ management officials” was GAO able to obtain the data it was seeking.

The Ensuring 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 regulated community. That’s why it defined the agency’s immediate suspension order authority. That’s why it provided for corrective action plans. This wasn’t some effort to help drug companies kill people. Give me a break. This was an effort to ensure that DEA’s praiseworthy efforts to stem abuse don’t end up hurting legitimate patients.

Now, I’d like to say a word about how this law came together. I want to be clear right at the outset that this was not a pharma bill. Don’t tell me I did this bill because pharma donated however much money to me.

Prior to introduction, Senator Whitehouse and I negotiated with DEA, distributors, and patient advocacy groups. We may have talked to a pharma company at one point or another, but they were not key players.

And 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, legislating is a process, and after introduction I found it was necessary to make changes in order to move the bill forward. I would have preferred not to, but we all know that legislation requires compromise. And so I had to accommodate some requests from industry stakeholders at the request of other members of this committee.

I negotiated these changes with DEA and DOJ. In fact, DOJ gave me the substantial likelihood language that critics now seem so fixated on.

And once DEA and I came to a point where we agreed on a path forward, I asked the Chairman to put the bill on a markup. And I kept my end of the bargain. I told other members what DEA had asked me to tell them, and I made the floor and record statements I’d promised DEA I would make. I did all of this in good faith.

I later came to find out that notwithstanding our agreement, DEA and DOJ were telling other offices they still had some concerns with the bill. For reasons I don’t understand, they never shared these concerns directly with me. But evidently the concerns weren’t that significant, as DEA didn’t try to stop the bill. As all of us on this committee know, any bill can be stopped by agency opposition. All it takes is one hold.

So that’s how we got here. This bill addressed a very real problem, and it did so in a carefully crafted, carefully negotiated way. If DEA has concerns with the bill, I’m happy to hear them. But I’d also ask DEA to explain why those concerns didn’t cause it to stop the bill 18 months ago, before it became law.

Thank you, Mr. Chairman.