FDA Accountability for Public Safety Act (S 1078, 115th Congress)

The Policy

What it does

Establishes procedures regarding the approval of controversial opioid drugs by the Food and Drug Administration.

Synopsis

S 1078, the FDA Accountability for Public Safety Act, builds upon a provision in the recently-enacted Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-198). In section 106 of that law, a pharmaceutical drug manufacturer submitting a new opioid drug for Food and Drug Administration (FDA) approval would in certain cases first have to submit that application to an FDA advisory committee for their recommendations. S 1078 clarifies that, if the relevant advisory committee recommends against the opioid drug's approval, the FDA Commissioner themself must issue the decision to approve the drug and cannot delegate that decision to other officials within the FDA.

In making this decision, according to S 1078, the FDA Commissioner must also submit a report to the Senate Committee on Health, Education, Labor, and Pensions, and to the House Committee on Energy and Commerce. This report must detail medical and scientific evidence justifying the opioid drug's approval, especially in light of the advisory committee's recommendation to deny approval of the drug, and must disclose any potential conflicts of interest of FDA officials who may have assisted the FDA Commissioner in making the approval decision. Should either Committee request it, the FDA Commissioner must also testify in front of those Committees about the decision to approve the opioid drug.

Context