Stacked FDA Peptide Advisory Committee Delivers for RFK Jr.
WASHINGTON, D.C. – The Pharmacy Compounding Advisory Committee at the U.S. Food and Drug Administration (FDA) voted 8-6 with one abstention to recommend that popular BPC-157 peptide substances (free base and acetate) be placed on the FDA’s 503A bulks list, which would allow their compounding by certain pharmacies. The vote rejected the recommendation of FDA scientists that BPC-157 “NOT be included” on the list because the substances are not well characterized, have limited information about their safety and immunogenicity risks, and have insufficient evidence about their effectiveness for ulcerative colitis, which has other FDA-approved therapies.
All eight votes in favor of adding BPC-157 to the list were from committee members recently appointed by U.S. Department Health and Human Services (HHS) Secretary Robert F. Kennedy Jr’s FDA, including physicians with conflicts of interest because they sell peptides, a compounding pharmacist, and a pharmacy business executive. Kennedy is a strong proponent of unproven peptides, which he has used to treat his own injuries, and has pledged to end the FDA’s “war” on peptides. The committee is expected to vote on six more peptides.
Nina Zeldes Ph.D., a Health Research Group researcher for Public Citizen, was one of the few public speakers who urged the committee to vote no.
“BPC-157 substances should go through the standard FDA approval process for new drugs and not be added to the 503A bulks list. Adding BPC-157 to the list would set a dangerous regulatory precedent and put patients at risk.”
Dr. Robert Steinbrook, Health Research Group Director at Public Citizen, added:
“A stacked FDA advisory committee has delivered for Secretary Kennedy, disregarding the evidence-based conclusion of FDA scientists that BPC-157 peptide substances should not be placed on the 503A bulks list. For its own credibility and to protect public health, the FDA must stand firm, reject the anti-scientific recommendation of an advisory committee rife with conflicts of interest, and not allow the compounding of BPC-157.”