S603-118

What This Bill Does
This bill sets new rules for how the Food and Drug Administration (FDA) can approve opioid drugs when its advisory committee doesn't recommend approval. The goal is to ensure that decisions to approve these potentially dangerous drugs are transparent and well-supported by scientific evidence.

Who Benefits and How
Patients who need opioids for pain management might benefit if the bill leads to more effective or safer medications being approved. Additionally, the public could benefit from increased transparency in drug approvals, as the FDA would have to provide detailed reports justifying its decisions.

Who Bears the Burden and How
Pharmaceutical companies that develop opioid drugs may face additional scrutiny and delays because they must wait for a thorough report before bringing new opioids to market. Taxpayers might also bear some costs if more resources are needed to produce these detailed reports and manage the approval process.

Key Provisions
- The FDA Commissioner, not lower-level officials, must personally approve any opioid drug that the advisory committee doesn't recommend.
- If an opioid is approved against the recommendation of the advisory committee, the Commissioner must submit a detailed report to Congress with medical and scientific evidence supporting the decision.
- The Commissioner must disclose any potential conflicts of interest involving FDA officials involved in approving the drug.
- The Commissioner can be called to testify before congressional committees about these decisions if requested.