The FDA Accountability and Public Safety Act (HR 5632) would require the Commissioner of the Food and Drug Administration (FDA) to personally approve an opioid medication for marketing, if relevant FDA experts have advised against doing so.
Specifically, the bill would bar the FDA Commissioner from delegating the approval of any New Drug Application (NDA) or supplementary materials for an opioid, if that approval is in conflict with the recommendations of the FDA Anesthetic and Analgesic Drug Products Advisory Committee.
If the FDA Commissioner decides to approve an opioid for market under such circumstances, they would be required to justify their decision by submitting a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. This report would present:
- Clinical evidence of the medication’s safety for patients, in support of its approval against the Advisory Committee’s recommendation; and
- Potential conflicts of interest among FDA officials who had a role in the deliberation for the NDA.
The opioid medication in question would not be allowed onto the market until the Commissioner’s report is received by the abovementioned committees. Additionally, if the committees request it, the FDA Commissioner could be called to testify in Congress about their decision to approve the opioid for marketing against the recommendations of the advisory committee.