HHS doubles down on controversial peptides plan

US Health Secretary Robert F Kennedy Jr has pushed ahead with a policy to allow licensed pharmacies and other groups to produce certain unapproved peptides – before the FDA has decided whether they should be allowed in compounded medicines.

A draft version of the "Enforcement Discretion Policy" published in the Federal Register notes that "HHS believes that there is significant interest in the use of these peptides in compounding given the lack of availability of approved products."

The enforcement discretion would mean that federal facilities and licensed pharmacies and physicians could start to produce six unapproved bulk peptides which do not have a USP or NF monograph and are not currently on the 503A bulks list, namely:

• BPC-157 for tissue repair and healing;
• Epitalon for sleep/insomnia and longevity;
• KPV for wound healing and inflammatory skin conditions;
• MOTS-c for metabolism, obesity, and osteoporosis;
• Semax for chronic pain and migraines; and
• TB-500 for tissue repair and muscle recovery.

The peptides were backed in July – narrowly – by the FDA's Pharmacy Compounding Advisory Committee (PCAC), after Kennedy overhauled the roster of the panel ahead of the meeting to include members with ties to the peptide industry and, in some cases, who own clinics that offer them to patients.

That decision came despite assertions by FDA staff scientists that there is a serious lack of evidence for their safety and efficacy, no standardised chemical formula to make them, and little data on their use in combination, given that users often bundle the peptides into 'stacks'.

For example, BPC-157 and TB-500 are sometimes used together in a stack known as "Wolverine" that is claimed to provide rapid muscle, tendon, ligament, and injury recovery.

Among their concerns were the potential of unregulated peptides to contain contaminants and impurities and to trigger unintended immune responses, particularly if the formulations do not prevent peptide aggregation or clumping together.

Critics of the move also believe that there could be widespread confusion among the public about the status and safety of these compounded medicines, mistakenly thinking they have gone through rigorous testing and are FDA-approved.

Kennedy himself is an enthusiastic, self-described "big fan" of these peptides and has admitted using them himself, calling FDA restrictions regulatory overreach, and that has raised the hackles of those who believe the HHS Secretary is using his position to further his own agenda.

HHS has said the measure is intended to prevent users from sourcing the peptides from unsafe, black market sources, often produced overseas – a defence that will evaporate if any peptides made during the enforcement holiday are found to cause adverse reactions.

The Centre for Science in the Public Interest (CSPI), a consumer advocacy group run by former FDA official Dr Peter Lurie, has said the move "threatens to not only expose the public to the dangers of unproven peptides but also threaten the integrity of the advisory committee system and the FDA’s drug approval process itself."

Photo by Sam Moghadam on Unsplash