An FDA advisory committee voted to allow compounding pharmacies to create custom medications using four peptides, despite concerns from agency scientists regarding safety and efficacy.
Key facts
- •The advisory panel voted 8-6 to add three of the four peptides to the FDA's bulks list, while MOTs-C received a 7-5 vote in favor.
- •FDA scientists recommended against allowing the compounding of the seven peptides under review due to a lack of safety and efficacy data.
- •The World Anti-Doping Agency has stated that BPC-157 poses health risks to athletes because it has not been extensively studied in humans.
- •The panel included members with ties to peptide-related businesses and telehealth clinics.
- •The FDA is scheduled to consider three additional peptides on Friday.
An FDA advisory panel voted eight to six on Thursday to recommend reclassifying four peptides—BPC-157, KPV, TB-500, and MOTs-C—to allow compounding pharmacies to legally produce them. The decision followed an 11-hour meeting where experts reviewed data on the substances, which are currently sold in an unregulated gray market. While proponents argue that legal compounding provides safer access, FDA scientists recommended against the move due to a lack of evidence regarding safety and effectiveness.
Debate Over Safety and Regulation
FDA scientists advised against allowing the production of these peptides, citing insufficient data. Conversely, some health care providers testified that patients currently purchasing from the gray market risk receiving products laced with illicit substances. Proponents, including representatives from telehealth providers, argued that legalizing compounding would offer patients regulated, prescription-based alternatives. Critics of the recommendation, including physician Adriane Fugh-Berman and chair of the Collaborative for Evidence-Based Medicines John Hertig, expressed concern that the move could confuse patients by implying FDA approval. They argued that the existence of a gray market does not justify the legalization of unproven substances and that the focus should remain on rigorous scientific study.
Context of Peptide Popularity
Peptides, which are small proteins, have gained popularity through endorsements from wellness influencers, podcasters, and Health and Human Services secretary Robert F. Kennedy Jr. They are marketed for various uses, including injury recovery, gut health, and skin rejuvenation. BPC-157 and TB-500 are specifically used together in a combination known as the "Wolverine stack." In 2023, the Biden administration banned compounding pharmacies from producing 20 peptides due to safety concerns. Currently, these substances are often sold online for "research use only." The advisory panel's recommendation is not final, and a formal decision from the FDA is expected in several months.
Advertisement
This article was independently rewritten by ManyPress editorial AI from reporting originally published by Wired.
