FDA needs to overrule its advisory committee on peptides, consumer group says

The Trump administration’s efforts to make poorly studied peptides more widely available to consumers should be stopped, the Center for Science in the Public Interest, or CSPI said in a letter to the Food and Drug Administration.

The CSPI expressed concerns over the agency’s Pharmacy Compounding Advisory Committee, or PCAC, meetings in July at which the committee voted to recommend six out of seven peptides for inclusion on the list for bulk drug substances available for use in compounding.  

The committee voted to include the peptides on the compounding list, known as the 503A Bulks List, even though FDA staff scientists recommended against listing them, saying the agency’s previous view is that the substances raise significant safety concerns. By law, the FDA is required to evaluate substances based on four criteria: their physical and chemical characterization, safety, effectiveness, and historical use.,

None of the peptides sufficiently met these standards when considered together and FDA staff concluded that all seven peptides should “not be included on the 503A Bulks List,” according to FDA briefing materials.

Some of the eight newly appointed PCAC members were reportedly placed on the committee under pressure from Health and Human Services Secretary Robert F. Kennedy Jr. to advance his publicly stated goal of ending the FDA’s “war on peptides.” At least six of the new members have financial ties to peptide businesses or clinics, according to published reports. Despite these apparent conflicts, the FDA’s Designated Federal Officer announced at the meeting that no conflict-of-interest waivers were issued. 

Seven of these eight new members openly cited extra-regulatory criteria, such as “medical freedom,” the “gray market,” and “bioterrorism,” to justify their votes. Every favorable vote for listing the peptides came from the newly appointed members. 

“If this conflicted committee’s recommendations stand, charlatans will continue to put unsuspecting consumers at risk of serious injury by making unsupported claims about their purported benefits,” said Peter G. Lurie, M.D., CSPI president and a former associate commissioner at the FDA. “Moreover, if the recommendations stand, they would undercut FDA’s own drug approval authority and thwart the development of new peptide-based drugs that might actually be safe and effective, like the existing GLP-1 drugs, because legitimate pharmaceutical companies will know that any compounder can produce them.” 

Because the PCAC’s role is advisory, the CSPI urges the FDA to take the recommendation of its own scientific staff and reject the committee’s, and refuse to add the unproven compounds to the 503A Bulks List. The group warns that moving forward with a rulemaking based on this flawed vote would undermine public trust and leave the agency vulnerable to legal challenges. The CSPI wants to meet with the FDA on the issue.

“Given these concerns, allowing the compounding of peptides based on PCAC’s vote would be antithetical to FDA’s mission of protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices,” the CSPI said in its letter. “These irregularities provide ample justification for the agency to side with its own scientific staff over the conflict-ridden votes and frequent extra-regulatory justifications offered by certain members.” 

CSPI’s concern comes as reports of consumers getting injured after receiving compounded peptide injections continue to mount, Lauri said.