By Basant El-Faramawy
Health Secretary Robert F. Kennedy Jr. announced Thursday that the Department of Health and Human Services will allow the widespread use of six unapproved peptide compounds, overriding previous Food and Drug Administration guidance advising against their use.
Policy Details
Under the new policy, HHS will not take enforcement action against doctors, pharmacies, and other facilities that sell the six peptide compounds. Compounding involves combining or altering drug ingredients to create tailored medications. While some FDA-approved peptide compounds exist, such as insulin and GLP-1 drugs for weight loss, compounded versions are not FDA-approved. HHS acknowledged in a Wednesday document that these drugs can "pose risks to patients" but argued there is "significant interest in the use of these peptides in compounding."
FDA Opposition
FDA scientists had little input on the decision and opposed the changes, according to six people familiar with the matter who spoke to the Associated Press. The agency had previously advised people not to use unapproved peptide injections.
Kennedy's Personal Advocacy
Kennedy, who told podcaster Joe Rogan in February that he is "a big fan of peptides" and has used them for injuries with "really good effect," stated the policy "advances patient choice and freedom while appropriately protecting patient safety."
Safety Requirements
HHS spokeswoman Emily Hilliard said the policy requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable. She emphasized that the policy "does not grant F.D.A. approval or establish clinical safety and effectiveness."
