HHS eases rules for unproven peptides

The Department of Health and Human Services acted on Wednesday to allow specialty pharmacies to sell several injectable peptides that lack formal approval from the Food and Drug Administration. The move, driven by Health Secretary Robert F. Kennedy Jr., permits the sale of compounds such as BPC-157, TB-500, and KPV despite their status as unproven drugs under existing federal rules.

Six people familiar with the internal deliberations told The Associated Press that FDA scientific staffers had minimal input in the decision process and opposed the changes. They described the policy as a departure from the agency's standard mission of keeping unverified health products off the U.S. market.

The draft policy, posted online for public comment, directs the FDA not to take enforcement action against pharmacies selling these specific wellness peptides. Normally, chemicals that have not undergone the FDA's rigorous review for safety and effectiveness are considered illegal drugs. The government will accept comments on the measure for two weeks.

Kennedy stated in the document that the change advances patient choice and freedom while protecting consumers from peptides sold online that often contain unscreened ingredients. He has previously described himself as a big fan of the compounds and noted using BPC-157 to treat a personal muscle injury.

Lee Rosebush, of the American Academy of Peptide Medicine, called the move a huge step for medical freedom. The group represents individuals who prescribe or sell peptides but is not a traditional medical professional organization. Major telehealth providers have taken note of the shift, with Hims & Hers announcing plans to offer wellness peptides once the policy changes take effect.

Wall Street analysts estimate the peptide market could be worth more than $2 billion. While some peptides occur naturally in the body to trigger hormones for growth and metabolism, the specific chemicals in this policy have not been approved by the FDA for conditions such as insomnia, anxiety, or migraines.

Dr. Peter Lurie, a former FDA official and current head of the Center for Science in the Public Interest, warned that diverting patients from rigorously tested drugs toward these compounds could lead to more unnecessary pain and suffering. He also questioned the timing of the announcement, which came days before the midterm election.

Lurie characterized the decision as a gesture to Kennedy's Make America Healthy Again supporters in hopes they would show up at the polls. An HHS spokesperson said the agency is confronting the risks of black-market peptides by providing a more controlled alternative through licensed U.S. compounders.

The final policy is a step back from an original HHS plan that would have required the FDA to draft a regulation adding the peptides to a list of safe drug substances. FDA officials warned that their scientific staff had major safety concerns with that approach. Instead, HHS moved to a non-enforcement strategy, directing the FDA to look the other way while providing technical assistance to draft safety guardrails.

These guardrails include requiring pharmacies to use peptide ingredients from FDA-registered factories and collect data on side effects. However, Lurie noted that the FDA lacks the federal legal authority to enforce these specific pharmacy requirements. The Alliance for Pharmacy Compounding said it needs clarification on when the policy takes effect and how it will interact with state pharmacy boards, which traditionally regulate pharmacists.

Historically, decisions regarding compounding pharmacies have rested with the FDA, particularly after a 2012 outbreak of fungal meningitis linked to contaminated injections from a Massachusetts pharmacy. Former FDA officials said it is rare for HHS to lead on compounding policy, though federal law technically grants HHS authority over drug regulations that are delegated to the FDA.

The FDA added the six peptides in question to a list of substances that should not be compounded in 2023 due to risks of allergic reactions, kidney damage, and tumor growth. In July, FDA staffers reiterated that these compounds remained unproven. A panel of outside experts selected by HHS voted to drop the restrictions, a group that included doctors and consultants working within the peptide industry.