Ahead of an FDA advisory committee's meeting on the potential use of certain unapproved peptides in compounded drugs, the agency has moved to reclassify 12 of the drug substances from their previously restricted status.
The FDA’s Pharmacy Compounding Advisory Committee has been slated for an upcoming discussion on whether certain peptides from compounding pharmacies should be cleared for use, signaling a potential reversal of a 2023 decision by the agency.
The July 23 and July 24 meeting will go over the potential use of seven different peptides for specific uses such as ulcerative colitis, wound healing, obesity, opioid withdrawal and more, according to a notice in the Federal Register. Each of the peptides on the table is proposed for inclusion on the 503A Bulks List, which designates the bulk drug substances with which physicians and pharmacies can compound into drugs.
In September of 2023, the FDA removed 17 drug substances from consideration for the 503A Bulks list by redesignating them as category 2 substances, citing a number of potential safety concerns.
Category 2 means that the FDA “would consider” taking action against compounders found to be using the particular substances, as the agency has “identified significant safety risks relating to the use of these substances in compounding.”
The agency’s rationale for restricting the seven peptide drug substances that are now up for discussion in July largely centered on a lack of “sufficient information” regarding their safety when administered to humans. Besides the safety issue, there’s often little meaningful evidence of efficacy to support these product's claims, according to the Associated Press.
The potential change of heart from the agency comes as Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. promotes the use of peptides, recently telling podcaster Joe Rogan that he’s a “big fan” of peptides and has used them before “with really good effect” on prior injuries.
To hear Kennedy tell it, the FDA “illegally” moved the peptides to a Category 2 designation during the Biden administration, ushering in a “black market” for the products. The health secretary told Rogan he was hoping to make “about 14” peptides more accessible, noting that the FDA would soon take “some kind of new action” to that effect.
The FDA and Kennedy further outlined the agency’s plans ahead of the advisory committee meetings in an April 15 update to its section 503A categories. The changes see 12 peptides that will be discussed by the expert panel in future meetings removed from the Category 2 list, as well as taking one peptide out of Category 1. Each peptide’s category reclassification will take effect after seven calendar days as “the nominations were withdrawn by the nominators,” the FDA said.
It is not immediately clear which category the drug substances taken out of Category 2 will be moved to. If reclassified to Category 1, compounding pharmacies would be able to produce the products without fear of FDA enforcement as that list stipulates that the agency “does not intend to take action against a compounder” for making drugs using Category 1 substances. However, a Category 1 designation only speaks to compounding eligibility and doesn’t mean that the substances were FDA-approved.
Kennedy calls the move “long-overdue action to restore science, accountability, and the rule of law,” explaining in an X post that the committee’s experts will now “rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence” during the upcoming meetings.
“This action begins to restore regulated access and will immediately begin shifting demand away from the black market,” Kennedy wrote.
Peptides are short chains of amino acids found in several approved drugs, such as GLP-1 medicines, but the buzz around unapproved peptides has been heightened by influencers and celebrities pushing the drugs as a transformative wellness tool. Promoters of the drugs’ use in compounded medicines argue that the FDA’s 2023 action on peptides was an overreach of its authority and not backed by enough evidence, but former FDA officials contend that the decision was supported by safety concerns, ProPublica reported last month.
The FDA has recently taken a tougher stance on drug compounders, especially when it comes to compounded versions of GLP-1 medications for weight loss. After compounded versions of Novo Nordisk and Eli Lilly’s GLP-1s were made illegal following the resolution of shortages of the branded drugs, many compounding pharmacies took to the “personalization” argument, maintaining that selling personally tailored doses of the compounded drugs remains legal.
One such company involved in compounding GLP-1s, Hims & Hers, praised the FDA’s advisory committee plans as “an important step toward moving these treatments out of the gray market, and into more trusted channels,” the telehealth company’s chief medical officer, Pat Carroll, M.D., said in a Wednesday press release.
The July meeting will come after the FDA soon breaks a nine-month drought of advisory committee meetings. For its part, the FDA’s expert committee on pharmacy compounding last met in late 2024 to discuss other bulk drug substances to be potentially added to the 503A list.
Editor's Note: The story was updated at 9:50 a.m. ET, April 16, with information on an FDA revision to its section 503A categories and additional public comments from Kennedy.