FDA peptide vote backs four treatments despite agency safety warnings
FDA advisers voted to let compounders sell four banned peptides, rejecting agency scientists’ concerns about limited safety data.
By Tom Brennan · Health & Medicine Correspondent
3 min read
An FDA peptide vote on Thursday backed letting specialized pharmacies make and sell four treatments that the agency had barred three years ago, according to The New York Times. The recommendation matters because FDA scientists told advisers the products lack enough evidence to show they are safe or effective.
The outside advisory committee’s votes are recommendations and do not bind the FDA. By Thursday evening, the panel had supported four of seven peptide products under review, with votes on three others planned for Friday, the second and final day of the meeting, The Times reported.
The four products supported Thursday were BPC-157, KPV, MOTS-c and TB-500. The Times reported that the products are mostly injectable and are sold online as “research-grade” items, often with claims tied to tendon repair, brain health and other uses.
What are the peptide treatments under FDA review?
Peptides are short strings of amino acids that can send signals to cells, including signals linked to inflammation or collagen production. Some peptide-based medicines, such as insulin and GLP-1 drugs, have gone through FDA review; The Times reported that the four products endorsed Thursday have not.
FDA scientists pointed to a limited evidence base, according to The Times. Research in animals and laboratory studies has suggested possible effects in areas such as wound healing, osteoporosis and inflammation, while other limited research has raised safety concerns including serious allergic reactions and faster tumor growth.
Human evidence is sparse or absent for the products, The Times reported. Dr. Eric Topol, a cardiologist and founder of the Scripps Research Translational Institute in La Jolla, California, told The Times that key proof on safety and efficacy is missing.
Health Secretary Robert F. Kennedy Jr., who oversees the FDA, has supported easing restrictions on peptides. On a podcast last year, Kennedy said the agency should study products such as peptides, while patients and doctors should be able to decide whether to use experimental drugs.
Kennedy has also argued that the 2023 restrictions pushed consumers toward gray-market peptide products and that allowing regulated pharmacies to compound them would be safer, according to The Times. FDA officials told the advisory panel that the agency does not oversee the state pharmacy boards that primarily regulate compounding pharmacies, The Times reported.
The panel’s first vote, on BPC-157, was 8-6 in favor of allowing compounding pharmacies to dispense it. According to The Times, six committee members who have sold peptide products voted yes, along with a compounding pharmacist and a pharmacy business executive.
The Times reported that Kennedy’s office nominated eight new members to the advisory committee before the hearing, including six people who have sold peptide products. The Department of Health and Human Services said all advisers underwent the same ethics review required for FDA committee members and that candidates who failed to meet those standards were removed from consideration.
Dr. Brian Lee, a liver transplant physician at the University of Southern California in Los Angeles, voted against BPC-157. He said its measured effect was smaller than a placebo response, which can lead about 30% of patients to believe their condition has improved, and warned that endorsing it could cause harm.
More information on compounded drugs is available from the U.S. Food and Drug Administration.
This story draws on original reporting from Medical Xpress.