S. 603: FDA Accountability for Public Safety Act

This bill establishes additional procedures related to the market approval process for opioids.

Under the bill, a Food and Drug Administration (FDA) advisory committee must make recommendations regarding supplemental applications for opioids. Current law requires only that an FDA committee make recommendations on new drug applications.

The bill specifies that only the Commissioner of Food and Drugs may approve an opioid-related application against the recommendation of the committee. If the Commissioner approves such an application against a committee recommendation, the Commissioner must submit a report to Congress that includes (1) the evidence regarding patient safety that supports the Commissioner's decision, and (2) a disclosure of any potential conflicts of interest of FDA officials involved in the decision. The Commissioner must also testify before Congress regarding the decision, upon request. The drug in question may not be sold until the Commissioner has submitted the required report.

Written by the Congressional Research Service, Library of Congress.