An FDA advisory committee has recommended that three peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the restrictions on how they are produced by compounders.
In each of the separate votes, the same eight of the 15 members of the Pharmacy Compounding Advisory Committee (PCAC) voted to add the drugs back to the list, with the same six members voting 'no' and one abstaining.
The three drugs are among a group of seven injected peptides that are being reviewed Thursday and Friday by the PCAC. None have been approved by the FDA. In 2023, 12 peptides were reclassified, which restricted their use. In addition to safety concerns, the FDA cited a lack of evidence supporting their efficacy.
The recommended drugs—BPC-157, TB-500 and KPV—are synthetic anti-inflammatory peptides that have gained popularity in wellness and fitness influencer circles for supposed soft-tissue healing and bone repair capabilities. BPC-157 also is used as a treatment for ulcerative colitis.
The FDA is not required to follow the recommendations of the PCAC. The agency will make the final decision on whether the peptides can be manufactured by compounders.
Questions have been raised about conflicts of interest on the committee, as some members have been linked to clinics and other businesses that supply peptides.
Department of Health and Human Services Secretary Robert F. Kennedy has been a user of peptides himself and a supporter of restoring their access. To deflect some of the criticism, the FDA this week added eight new panelists as temporary voting members.
Thursday’s meeting included public comment from patients, physicians and compounding industry representatives who nearly unanimously urged for access to be returned to the peptides. Meanwhile, scientific experts from the FDA countered with concerns about safety and the lack of evidence of the unregulated treatments' effectiveness.
Making a decision on peptides is clouded by the FDA having difficulty determining what the exact components are that make up those like BPC-157.
“We can’t create quality standards until we know what it is,” Russell Wesdyk, the Associate Director for Regulatory Affairs in the Office of Product Quality Assessment at the FDA’s Center for Drug Evaluation and Research (CDER), said on Thursday. “This isn’t a criticism of the industry or anything else. It’s foundational with these common-named substances that are in early-stage research, you’ll see many, many different forms.”
One of the panelists who voted to restore BPC-157, David Pope, Chief Pharmacy Officer at XiFin Pharmacy Solutions, cited concerns of increased gray market access to peptides.
“It’s time to put this decision in the hands of the patient, the physician and the pharmacist,” Pope said. “And I would agree with the idea that we need to keep this in America.”
This week, leading up to the meeting, Carrie Carda, M.D., the National Medical Director at wellness company 10X Health told Fierce by email that “one of the biggest mistakes in medicine is confusing a lack of definitive evidence with evidence that something doesn't work.”
“This is one of the most important meetings in the history of peptide medicine,” Carda added. “The decisions made here are likely to influence the legal and regulatory framework governing peptide therapy for decades to come. While the discussion centers on seven peptides, the implications extend far beyond those individual therapies and will shape the future of the entire field.”