FDA panel votes to add peptides to permitted compounding list despite opposition from agency scientists
The Hill · C · trust 35/100
Comments: by Joseph Choi - 07/23/26 7:38 PM ET Comments: Link copied by Joseph Choi - 07/23/26 7:38 PM ET Comments: Link copied On Thursday, the Food and Drug Administration’s (FDA) committee on compounded drugs broke with agency scientists and voted in favor of adding peptides to the list of substances compounding pharmacies can make, despite concerns being raised over the lack of demonstrated benefits.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) heard public comments and saw presentations by agency staffers concerning the peptides BPC-157, KPV, TB-500 and MOTS-c. These peptides are purported to help with ulcerative colitis, wound healing, obesity and osteoporosis.
PCAC was tasked with recommending whether to add these peptides to the 503A bulks list, the substances that 503A compounding pharmacies can make and sell to consumers.
By 7 p.m. EDT on Thursday, the committee had voted in favor of adding BPC-157, KPV, and TB-500 to the list, though the vote was split nearly evenly with eight voting yes, six voting no and one member abstaining.
At the time of writing, the committee was still hearing comments and presentations about MOTS-c.
While opponents to adding these peptides to the list argued there wasn’t enough data to prove safety and efficacy, supporters essentially argued there was not enough to disprove these claims either.
Prior to the meeting, FDA scientists concluded in briefing material to the committee that all the peptides being considered lacked the necessary evidence to conclude that they were safe and effective for treating the conditions they were purported to help treat.
Staffers reiterated this stance on Thursday. One staffer noted potential issues like there being no standardization for peptides, sharing that the FDA had encountered many substances all being marketed as “BPC-157,” for example, that had different active molecules.
“Inconsistent naming conventions can contribute to the BDS being not well characterized because there is no basis for a long-term understanding of the composition of the BDS,” the staffer stated in their presentation, referring to bulk drug substances (BDS).
“There is no basis for an expectation that the common name will always identify the same BDS, the same specific chemical form and structure,” the staffer continued.
Supporters of adding these peptides to the list argued that doing so would direct consumers away from the gray market, where many eager shoppers source supposed “research-grade” peptides from online vendors overseas.
In explaining her “yes” vote, PCAC member Melissa Loseke said, “Just last week, I had a patient whose research grade whatever that they got from someplace that they brought to me to fix was laced with MDMA and ecstasy. That’s not protecting the American people.”
Asare Christian, one of several PCAC members who own clinics offering peptides, argued, “We are always taking risks with patients with all the interventions we do as physicians. And this provides an avenue, an alternative, to support the already existing available tools that we have to take care of patients.”
Several other members of the committee, however, concurred with FDA staffers that there simply was not enough evidence to support making these peptides available through compounding pharmacies.
In their first vote on BPC-157, PCAC members Elizabeth Rebello, Brian Serumaga and Josh Mailman were among those who said they believed there was not enough evidence demonstrating efficacy.
Brian Lee, associate professor of medicine at the Keck School of Medicine of USC, warned that while the vote on Thursday would not be an FDA approval, consumers would still perceive it as an endorsement of the peptides.
“I think that the data that we do have, the existing randomized data, is showing that BPC-157 may be no better than placebo,” said Lee. “And knowing that most important, serious safety events like liver damage, where there is potential concern here, aren’t detected by self-report. So, I think this endorsement can be potentially harmful, and it cannot in good conscience vote yes.”
Read the original at The Hill →
Open in TruthVane →