Stricter FDA oversight and transparency for approving new opioid drugs.
This bill establishes new rules to enhance public safety regarding the approval of highly addictive opioid drugs. If the FDA advisory committee recommends against approving an opioid, the final decision must be made personally by the FDA Commissioner, increasing accountability. The Commissioner must then publicly justify the decision to Congress with scientific evidence and disclose any potential conflicts of interest before the drug can be marketed.
Key points
Final approval for an opioid rejected by the advisory committee must come directly from the FDA Commissioner, ensuring higher accountability.
Approval against recommendations requires a written report to Congress detailing scientific evidence and disclosing potential conflicts of interest among FDA officials.
The drug cannot be sold until the required transparency report has been submitted to Congress.
Expired
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