Health and Human Services Secretary Robert F. Kennedy Jr. has initiated steps that might expand access to certain unapproved peptide drugs. These drugs are often promoted for enhancing wellness. On Wednesday, Kennedy introduced a draft policy allowing compounding pharmacies to prepare six specific peptides. These include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Notably, these peptides lack approval from the Food and Drug Administration (FDA).
Compounding Pharmacies and Patient Alternatives
According to Kennedy, the new policy is designed to offer patients a controlled alternative. Compounding pharmacies are tasked with mixing ingredients to create personalized medications for patients. Though these peptides have no FDA approval, they’re often marketed with health benefits.
No Immediate Enforcement
The Department of Health and Human Services has indicated it will not take action against licensed pharmacies or physicians compounding drugs using peptide substances absent in FDA-approved drugs. Peptides are small proteins capable of significant effects, with some, like insulin, holding FDA approval.
FDA-approved peptides in GLP-1 medications are used for weight loss and diabetes treatment. However, a recent FDA advisory panel vote favored the use of these six unapproved peptides in compounding. This decision contradicts FDA scientists who claim insufficient safety and efficacy evidence.
Kennedy remarked that his policy promotes patient choice and safety, referencing the panel’s recommendation. An HHS spokesperson stated that pharmacies are expected to perform quality and safety checks. Such measures aim to provide patients with knowledge about peptide drugs, setting them apart from unregulated sources.
Policy Requirements and Investigations
Despite not offering FDA approval nor confirming clinical safety and efficacy, the policy mandates patient-specific prescriptions, ingredients traceability, and quality safety reports. It holds compounders accountable, offering an alternative to unregulated sellers. Ingredients must come from an FDA-registered maker with lab certification for raw materials, along with serious side effect documentation.
In a recent CBS News investigation, an experimental peptide weight-loss drug, retatrutide, was purchased for testing from a Brooklyn bodega. The lab test revealed this sample lacked any peptide content. Last summer, CBS News found many clinics openly advertising retatrutide, yet it remains unreviewed by the FDA and in clinical trials by Eli Lilly.
This policy draft will be open for public feedback starting Friday through November 13. It will stay effective until the FDA issues a rule on compounded peptides. As of now, the FDA has not proposed such a rule.
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