FDA Review of Opioid Efficacy: New Standards for Clinical Trials.
This Act mandates the Food and Drug Administration (FDA) to re-evaluate a specific clinical trial method used to approve opioids for chronic pain. Within two years, the FDA must convene expert committees to vote on whether this methodology is scientifically sound and should continue to be permitted. The goal is to ensure that pain medications available to the public are proven effective and safe for long-term use.
Key points
The FDA must review and vote on whether a controversial testing method (EERW) can still be used to prove the effectiveness of opioid drugs.
All existing opioid drugs approved using this method will undergo a postmarket review to verify that their current labeling and indications are supported by evidence.
The National Academy of Sciences will conduct an independent study on the reliability of this testing method for chronic pain treatment.
Expired
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