Senator Ayotte's Statement on the FDA's Opioid Action Plan

Today, U.S. Senator Kelly Ayotte (R-NH) met with Department of Health and Human Services (HHS) Secretary Sylvia Burwell to discuss the Food and Drug Administration's (FDA) proposed Action Plan to combat the opioid abuse epidemic, particularly as it pertains to the FDA's approval process for opioid pain relievers.

"I appreciated the opportunity to meet with Secretary Burwell to discuss the FDA's new Action Plan, which acknowledges the need for the agency to give greater consideration to public health risks when considering new prescription opioids for approval. While this is a step in the right direction, I remain concerned that the plan does not immediately require the input of advisory committees for all opioids, including those that are more difficult to abuse. I also remain concerned about the FDA's decision to approve OxyContin for use by children, and believe the agency should convene an advisory committee to reconsider this controversial decision. I will continue to press the FDA on these concerns, and I look forward to working with the agency to ensure that it quickly and properly implements the Action Plan it has laid out today."

The FDA's Action Plan expands the use of the agency's advisory committees, includes changes to safety labeling and additional warnings about the dangers of long-term use of opioid medication, requires pharmaceutical companies to provide additional postmarket data, and increases continuing medical education for opioid prescribers.

According to the Substance Abuse and Mental Health Services Administration, 4 out of 5 heroin users have previously used pain relievers for non-medical purposes. New Hampshire state officials estimate that more than 400 individuals succumbed to a fatal drug-related overdose last year.

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