November 20, 2019

Senator Hassan Presses FDA Commissioner Nominee on Opioid Crisis, Flavored E-Cigarettes

To watch the Senator’s questioning, click here.

WASHINGTON – During Dr. Stephen Hahn’s nomination hearing before the Senate Health, Education, Labor, and Pensions Committee, Senator Maggie Hassan pressed the nominee for Food and Drug Administration (FDA) Commissioner for a full accounting of the FDA’s past actions regarding the approval and labeling of opioid products.

The Senator also called on Dr. Hahn to protect the integrity of FDA’s statutory authority over flavored e-cigarettes, specifically calling for public disclosure of all meetings between FDA and Juul, as well as any data FDA receives from companies like Juul related to youth e-cigarette use.

On the opioid crisis:

Senator Hassan began by highlighting that FDA has still failed to respond to a letter that she sent with Senator Ed Markey (D-MA) eight months ago asking basic questions about the decision-making processes for the approval and labeling of opioids, including the influence that drug manufacturers had on these decisions. The letter specifically asked about the problematic Enriched Enrollment Randomized Withdrawal (EERW) clinical trial methodology that FDA allows for opioid approvals.

Dr. Hahn committed to responding to the Senators within his first thirty days as commissioner should he be confirmed, adding, “I also want to emphasize, Senator, that I very much appreciate your approach here. And that is, it’s always important to have a look-back to see what happened, to see if you can have continuous improvement.”

Senator Hassan also asked Dr. Hahn how his own views on opioids have evolved since medical school, to which Dr. Hahn responded, “[…] When I first went to medical school and started taking care of cancer patients, the teaching was that cancer patients should be treated liberally with opioids, and that they don’t become addicted to pain medications. We found out that that wasn’t the case, with in some instances tragic consequences. […] If I’m fortunate enough to be confirmed as Commissioner of food and drugs, I look forward to furthering the education efforts for providers and patients.”

On flavored e-cigarettes:

The Senator also questioned Dr. Hahn about flavored e-cigarettes. The Senator began, “Right now, we are dealing with reports that the Administration caved to special interests in reversing the e-cigarette flavor ban, and that’s incredibly disturbing.”

When Dr. Hahn hedged on whether he would commit to publicly disclose all meetings between FDA and Juul regarding the flavored e-cigarette ban, and the forthcoming Premarket Tobacco Application Process, Senator Hassan said, “When I asked the FDA about what meetings they had, they said nothing to do with policy. They’re either lobbying or they’re not. And the American public has a right to know how decisions that affect their children and our public health are made and so I am very hopeful that we will get full disclosure from the FDA about their meetings with Juul and the information that Juul has brought forward. It was an issue with opioid approvals as well.”

###