The FDA's Pharmacy Compounding Advisory Committee (PCAC) on Thursday voted in favor of adding the peptides BPC-157, KPV, TB-500 and MOTS-c to the 503A Bulks list of substances permitted to be made and sold by compounding pharmacies.
These votes went in the face of FDA scientists who strongly advised that there was not enough strong evidence demonstrating the safety and efficacy of any of the peptides being considered by the committee.
Several members appointed by Health and Human Services Secretary Robert F. Kennedy Jr., who's called himself a "big fan" of peptides, own clinics or businesses that sell peptides.
The votes on Thursday were nearly evenly split, with one side arguing not enough evidence had been presented to support adding these substances to the list while supporters of the peptides argued there wasn't enough evidence to disprove the benefits either.
PCAC members returned on Friday to consider emideltide, semax and epitalon for addition to the compounding list. The panel ended up only voting against adding emideltide to the list, the first peptide to be rejected. Six members voted "yes," seven voted "no" and one member abstained.
Emideltide, a synthetic peptide, is purported to have potential use for treating opioid withdrawal, chronic insomnia and narcolepsy.
FDA staffers noted a common issue across all these peptides was that there was no standardization within the market, leading many products to carry the same name while having different molecular structures. They further characterized past studies on the peptide as being poorly constructed with small sample sizes and poor selection of control groups.
PCAC member Kevin Zacharoff explained his "no" vote saying, "It's impossible for me to not take the FDA's recommendations at heart with respect to safety and efficacy."
