The Pharmacy Compounding Advisory Committee voted Thursday to add the popular peptide BPC-157 to a drug compounding list.
The vote was eight to six with one abstention. The decision is nonbinding and still needs sign-off from the Food and Drug Administration, a step that would bring the peptide one step closer to being legally available to Americans with a prescription.
BPC-157 was the first of seven unapproved peptides the committee is reviewing. The panel has been weighing whether compounding pharmacies should be allowed to dispense the seven peptides with a doctor’s prescription for special medical conditions, and additional discussions and votes were expected Thursday and Friday.
FDA staff scientists highlighted a general lack of quality data supporting safety and effectiveness, and there is very little human clinical trial data for the peptides. Most of the studies done so far have been in rodents, and some health experts and doctors urged caution, saying there is not enough research on the peptides’ safety and efficacy.
Committee members who voted yes generally believed the risks to be minimal, while those who voted no tended to worry about safety risks and effectiveness and said adding the peptide to the compounding list could create a false impression that it had been evaluated to the same rigorous standards as an FDA-approved drug.
BPC-157 has been touted online as a way to promote gut and tissue healing. Peptides are strings of amino acids and have exploded in popularity online, with wellness influencers and podcasters suggesting they can help build muscle, improve metabolism and more, a trend that has driven growing demand. Many popular peptides are currently only available on the black and grey market.
The committee is considering an atypical regulatory pathway that would allow these substances to be compounded rather than going through the full FDA approval process. Health and Human Services Secretary Robert F. Kennedy Jr. has promoted the use of peptides, and HHS has faced criticism that many of the newly appointed members to the committee have financial conflicts of interest.
NBC’s medical contributor Natalie Azar joined TODAY to break down the seven peptides and how effective they are.