With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns.
The FDA has scheduled a meeting to discuss allowing compounding pharmacies to manufacture peptides that it previously warned carry significant safety risks.
Seventeen peptides nominated for inclusion on the two bulk lists of ingredients eligible for production by compounding pharmacies present a notable safety risk, the FDA said in September 2023. In explaining its decision, the agency flagged concerns about “complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization,” the potential for aggregation and a lack of human safety data.
Under new leadership, the FDA has arranged a two-day meeting in July to gather independent expert advice on seven peptides. Six of the peptides were among those the agency raised safety concerns about in 2023. The FDA plans to meet to discuss another five peptides by the end of February 2027.
The first batch of peptides up for discussion includes BPC-157 in ulcerative colitis, KPV in wound healing, and MOTs-C for obesity and osteoporosis. MOTs-C may pose significant risk for immunogenicity for some routes of administration, the agency said in 2023. The FDA also previously highlighted impurity and API characterization concerns for BPC-157 and MOTs-C and an absence of human exposure data for KPV.
Health Secretary Robert F. Kennedy Jr. discussed the FDA’s actions against the peptides with podcaster Joe Rogan in February. Kennedy claims the FDA illegally moved the peptides to category 2—which covers substances that raise significant safety risks—during the Biden administration. The actions were illegal because the agency lacked the safety signal needed to trigger the categorization, according to Kennedy.
With compounding pharmacies unable to make the peptides, Kennedy said a black market has emerged, run by companies that say they are making the molecules for animal use or research purposes. Kennedy, who called himself “a big fan of peptides” based on his personal experiences, said he hopes the FDA will grant people access to the molecules from “ethical suppliers.”
The FDA is seeking feedback on the seven peptides scheduled for discussion at the meeting in July. The agency’s Pharmacy Compounding Advisory Committee currently has six vacancies, including for the post of chairperson.
