HHS对六种肽类药房配制发布执法裁量政策

The letter clarifies that HHS may revisit the interim policy if it leads to new safety signals or product quality issues. (Photo by Andrew Harnik/Getty Images)

Stopping short of a formal declaration allowing their use, Department of Health and Human Services secretary Robert F. Kennedy Jr. has cleared the way for the compounding of six popular wellness peptides.

The move, which comes after the same peptides won favor at an FDA advisory committee meeting this summer, is being hailed by some in the industry as offering a more accountable alternative to the gray market many peptide-seekers currently use, while others have charged that it undermines institutional FDA pushback on the drugs, which have become increasingly popular among fitness influencer circles and the MAHA crowd.

Under Kennedy’s “enforcement discretion policy”issued Wednesday, HHS will not take enforcement action against pharmacies, physicians and federal facilities compounding six specific peptides, assuming those parties meet certain specific qualifications.

The specific compounds included (PDF) in the list are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, all of which were discussed in a meeting of the FDA’s Pharmacy Compounding Advisory Committee (PCAC) in July, with the panel ultimately voting to recommend including the treatments onto the 503A Bulk Drug Substances list.

Advisory committee votes are recommendations, not binding decisions, and the peptides still haven’t been added to the drug substances list in an official capacity.

Kennedy cited that meeting in his enforcement decision, alongside data on utilization pf peptides, noting that HHS believes there is “significant interest in the use of these peptides in compounding given the lack of availability of approved products.”

The letter clarifies that the agency may revisit the interim policy if it leads to new safety signals or product quality issues.

The new policy comes with several other caveats that compounders must satisfy too, including sourcing their bulk drug substance from an FDA-registered facility and ensuring that the ingredients are properly characterized and identified. The original manufacturer of the bulk drug substance must also be registered with the FDA, according to HHS’ document.

In another change from typical compounding practice, compounders will be required to report quality issues and serious adverse events associated with the newly unrestricted peptides that are associated with their use, whether the drug itself is considered related or not, HHS clarified.

Compounded drugs are not FDA-approved. Traditionally, the compounding practice has focused on the mixing or altering ingredients of a drug to create a custom medication for a patient.

The practice can also come into play in order to fill drug shortages, which led to the pop-up of a GLP-1 compounding cottage industry for obesity that branded drugmakers Novo and Eli Lilly have continued to grapple with, even after supply shortfalls of their licensed medicines were declared formally ended in the United States.

In a statement Wednesday, Alliance for Pharmacy Compounding (APC) CEO Scott Brunner said he welcomed the decision, noting that it isn’t a question of whether patients are already using these six peptides, but of “where they’re getting them.”

“Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what's actually in the vial,” he said. “That's an existing public health threat, and one that isn't going away simply because compounding of the substances is prohibited.”

While noting that the policy now offers a “more accountable alternative” to that murky peptide supply chain, Brunner emphasized the importance of the limits the enforcement action puts in place as well, while also highlighting questions that remain, including when the policy actually takes effect, how API testing and analysis will be validated and how product utilization reporting will work.

“That last point is especially important,” Brunner said. “A credible federal policy with meaningful patient safety safeguards gives states a sound basis for their own oversight and helps discourage a patchwork of state rules and restrictions that could undermine the access HHS is trying to provide.”

Others, including consumer advocacy nonprofit Public Citizen, adopted a decidedly more antagonist tone toward the new enforcement policy. In a statement issued this week, the group noted that the peptides included in the new list are “popular but unproven and unapproved,” flagging Kennedy’s own personal support of the compounds.

Questions around conflicts of interest among panelists on the PCAC panel were also raised this summer, with the FDA quickly slotting in eight temporary voting members ahead of the confab in a bid to appease some of the criticism.

With the move, Kennedy “has acted recklessly and unilaterally to put Americans in danger,” Robert Steinbrook, M.D., Public Citizen’s health research group director, said in a statement, contending that the HHS secretary ought to “support, not sabotage, needed FDA enforcement actions to protect consumers.”