October 17, 2017

In HELP Committee Hearing, Senator Hassan Presses Drug Distributor Representative on Efforts to Undermine DEA’s Enforcement Authority


Click here for video of the hearing. 

WASHINGTON – Senator Maggie Hassan pressed a drug distributor representative today on the industry’s efforts to undermine the Drug Enforcement Agency’s (DEA) authority to crack down on opioid distributors during a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing. Senator Hassan highlighted comments from the DEA Chief Administrative Law Judge stating that the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 makes it much harder for the DEA to use its authority.

Click here for video and see below for Senator Hassan’s questioning of Elizabeth Gallenagh, Senior Vice President of Government Affairs and General Counsel for the Healthcare Distribution Alliance (HDA), the trade group representing drug distributors:

Sen. Hassan: Ms. Gallenagh, I want to discuss with you my serious concerns about the Washington Post / 60 Minutes report this weekend on a bill from last year that your organization lobbied for aggressively. The DEA had the power to immediately stop distributors from supplying opioids and other prescription drugs to pill mills and other corrupt sources. But according to the DEA Chief Administrative Law Judge, last year’s law makes it much harder for the DEA to use that power. Under the new law, the agency must provide substantial evidence that a distributor’s actions makes death or serious bodily harm considerably more likely. And the DEA needs to do so before any witnesses are produced or any evidence is admitted at a hearing. As a result, the judge writes that the law appears to, and this is his quote, “completely eliminate the DEA’s ability to ever impose an immediate suspension.” Yet, Ms. Gallenagh, your organization’s spokesperson told the Washington Post, “To be clear, this law does not decrease DEA’s enforcement against distributors.” That’s a direct contradiction from what the judge is saying – and it’s his job to interpret the law. Doesn’t that make your organization’s statement pretty misleading?

Ms. Gallenagh: Thank you for the question, Senator. The opioid epidemic in general is a very serious concern and a complex issue that we are also very concerned about as distributors. And we work with our supply chain partners daily to try and find solutions to that.

Sen. Hassan: Ms. Gallenagh, I understand that. But here's the point. The point is that your organization – which lobbied aggressively for this law last year – claimed that it does not decrease the DEA’s enforcement against distributors. The DEA Chief Administrative Law Judge says you’re wrong – that the law completely eliminates the DEA’s ability to take certain enforcement actions. It’s his job to interpret the law. So is the judge wrong? Or was your organization's statement misleading?

Ms. Gallenagh: In that sense, I believe that the judge's statement was misleading. And I stand behind our organization's statement.

Sen. Hassan: I'd suggest you read the judge's article which has now been published. Because what he points out among other things, is that for all this time when there wasn't a statutory definition of immediate harm, that constrained the DEA the way the bill that was passed last year does, over many, many years, the industry didn't challenge the DEA's actions because very often there's almost no case law on it. So I'd suggest you go read it because there are a lot of us extraordinarily worried.