FREED of Opioids Act
- Last Action
- 5/13/2021
CRS Summary
As of 2021-05-13 (00)
FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act
This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials.
Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain.
The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study and vote on whether to permit the use of this methodology in drug clinical trials.
Cosponsors (1)
- Mike Braun (R-IN)
Subjects
- Advisory bodies
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug trafficking and controlled substances
- Drug, alcohol, tobacco use
- Food and Drug Administration (FDA)
- Government studies and investigations
- Medical research
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.