FDA sends White House interim access policy easing peptide enforcement
People familiar with the proposal say it would grant enforcement discretion on certain peptides, reassuring compounders despite FDA scientists' safety objections.
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By Daniel Okafor · Regulatory Correspondent
Oct 16 13:05 ETSource: Ars Technica
The wire
- 01An OMB filing shows the FDA submitted an "Interim Access Policy" on peptides for White House review; sources told the AP it would give the agency enforcement discretion on certain peptide drugs.
- 02Compounding pharmacies could gain assurance they will not be targeted while formal rulemaking to restore peptides to the 503A list drags on for years.
- 03FDA staff scientists concluded in 2023 the 12 peptides under re-review lack safety and efficacy data; CSPI has urged Acting Commissioner Kyle Diamantas to disregard the advisory panel's July recommendations.
From the source
Read at arstechnica.comRFK Jr. proposes FDA look the other way on unproven peptides, report says
Under Health Secretary Robert F. Kennedy Jr., the Food and Drug Administration is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy’s Make America Healthy Again movement—despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.
