The upcoming July FDA panel on peptide therapies marks a significant shift in composition, as the agency's new list of participants includes doctors and pharmacists with ties to the peptide industry. This contrasts sharply with previous panels that were composed of academics from major universities. Source: AP The panel will reconsider the designation of seven popular peptides, including BPC-157 and TB-500, which have been promoted by Health Secretary Robert F. Kennedy Jr. but flagged by FDA scientists for lacking evidence and raising safety concerns. Source: NPR
FDA scientists have recommended against changing the restrictions on these peptides, citing insufficient evidence from large-scale human trials. Source: NPR However, Secretary Kennedy has openly supported the use of such peptides, saying he has used them himself. Source: NPR
The panel's members include Dr. Haleem Mohammed, who runs clinics that sell injectable peptides and other unapproved therapies, and Dr. Gabriel Alizaidy, who charges $500 for "peptide and hormone" consultations. Source: CNN A previous iteration of the panel had voted against several peptide ingredients, deeming them too risky. Source: AP
The two-day meeting on July 23-24 will examine the evidence for specific indications like wound healing and obesity, with a follow-up in February for additional peptides. Source: NPR The outcome remains uncertain, as the panel must weigh the industry-backed proponents' views against the FDA scientists' concerns. Source: AP
“FDA scientists flag potential safety concerns and a lack of consistent data.”
“The FDAâs new group mainly includes health professionals who prescribe, produce or promote peptides, which have become a wellness trend among athletes, influencers and celebrities.”
“Panel member Dr. Haleem Mohammed runs clinics in Florida that sell injections of peptides, vitamins, testosterone and weight loss medications.”
“Secretary Kennedy has made no secret of his support for the molecules, saying he has used some of them himself and would like the FDA to allow compounding pharmacies to again offer the drugs.”