Peptides: FDA expected to lift restriction after RFK Jr.'s push

The FDA is moving toward allowing compounding pharmacies to make 14 injectable peptides that were removed from its list in 2023, and Health Secretary Robert F. Kennedy Jr. has publicly advocated reversing the ban; the agency plans to convene its Pharmacy Compounding Advisory Committee to review the matter.

The Food and Drug Administration is moving toward allowing compounding pharmacies to produce more than a dozen injectable peptides that the agency removed from its compounding list in 2023. Health Secretary Robert F. Kennedy Jr. has publicly pushed to reverse the prohibition and has said he has used some of the products. Officials and outside experts have raised safety concerns and noted that many of the peptides have limited clinical data and have circulated in an online gray market. Key points: - The FDA's 2023 removal covered 14 injectable peptides from the list compounding pharmacies could make. - A senior administration official said the agency is moving to allow some of those peptides to be compounded, while top FDA leaders reportedly have reservations. - The agency plans to convene the Pharmacy Compounding Advisory Committee to consider medical justification and vote on whether to add the peptides back to the compounding list. - Officials said the FDA intends to enforce rules against false or misleading claims about medical benefits, and outside experts noted that safety and efficacy data are limited. Summary: If the agency restores the peptides to the compounding list, many would continue to be produced in facilities not subject to the full good manufacturing rules that apply to approved drugs, and experts have pointed to gaps in evidence about benefits and risks. Agency officials have indicated they will enforce rules on false or misleading claims. The next formal step is a meeting of the Pharmacy Compounding Advisory Committee to review and potentially vote on the peptides' status.