The Food and Drug Administration announced on Apr. 16 that it will hold a meeting in July to discuss whether compounding pharmacies should be allowed to manufacture certain peptides that were previously flagged for significant safety risks.
This development is important because the FDA had previously identified seventeen peptides as presenting notable safety issues, including concerns about impurities, aggregation, and insufficient human safety data. The agency's actions have impacted access to these substances and raised questions about regulatory oversight and patient safety.
According to the FDA, six of the seven peptides up for discussion at the upcoming two-day meeting were among those highlighted for risk in September 2023. These include BPC-157 for ulcerative colitis, KPV for wound healing, and MOTs-C for obesity and osteoporosis. The agency said MOTs-C may pose a significant risk of immunogenicity depending on how it is administered. There are also ongoing concerns about impurity levels and lack of human exposure data for some peptides.
Health Secretary Robert F. Kennedy Jr., speaking with podcaster Joe Rogan in February, said "the FDA illegally moved the peptides to category 2—which covers substances that raise significant safety risks—during the Biden administration." Kennedy said this was done without sufficient evidence: "The actions were illegal because the agency lacked the safety signal needed to trigger the categorization." He also commented on consequences from these restrictions: "With compounding pharmacies unable to make the peptides...a black market has emerged," adding he hopes people will gain access through “ethical suppliers.”
The FDA plans further meetings by February 2027 regarding five additional peptides. Meanwhile, it is seeking public feedback on those scheduled for discussion in July. The Pharmacy Compounding Advisory Committee currently has six vacancies, including its chairperson position.
As regulatory reviews continue, observers are watching how decisions could affect both patient access and industry practices related to peptide therapies.
