April 05, 2017

In HELP Committee Hearing, Senator Hassan Presses FDA Nominee Gottlieb on Combating Substance Misuse

In HELP Committee Hearing, Senator Hassan Presses FDA Nominee Gottlieb on Combating Substance Misuse

Senator Hassan Points to Problematic "Abuse Deterrent" Label, Highlights Importance of Risk Evaluation and Mitigation Strategies

WASHINGTON - Today, Senator Maggie Hassan participated in the Health, Education, Labor, and Pensions (HELP) Committee hearing on the nomination of Dr. Scott Gottlieb to lead the Food and Drug Administration (FDA), where she pressed the nominee on the agency's role in combating the opioid addiction epidemic.

Senator Hassan raised the issue of designating certain opioids as "abuse-deterrent," pointing out that the label is misleading because these products are just as addictive as other opioids. Senator Hassan noted that "experts have done surveys that show that 46 percent of primary care providers think that these 'abuse-deterrent' products are less addictive than other opioids." Asked if he thinks the FDA has a role to play in ensuring that there is a common understanding among providers that products called "abuse-deterrent" are just as addictive as other opioids and are not abuse-proof, Dr. Gottlieb said "I echo your sentiments in many regards," adding, "I think within the scope of what I want to do to try to push the agency around looking at a different framework for how we address this problem, I would include that question."

Senator Hassan also questioned the nominee on his previously stated opposition to risk evaluation and mitigation strategies (REMS), a critical tool that the FDA has in combating the opioid addiction epidemic that includes prescriber training. Under questioning from Senator Hassan, Dr. Gottlieb appeared to walk back his prior comments on REMS and agreed with the Senator that they are an important tool that the FDA should continue to use widely.

During the hearing, the Senator also raised his troubling record on women's health care issues.

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