The American Medical Association has adopted a policy urging HHS, the FDA and other federal regulators to “immediately rescind” administrative policies or directives that ease restrictions on compounding and distributing synthetic peptides that haven’t been approved by the FDA.
The AMA cited concerns that unapproved peptides lack the safety, efficacy and quality evidence needed to support their use, according to the policy announced Nov. 9. “By allowing pharmacies to compound unapproved synthetic peptide substances without sufficient evidence of their safety and efficacy, patients are at increased risk of serious harm,” said AMA Board Member Ilse Levin, DO. She said the substances haven’t undergone the testing required of FDA-approved drugs and that expanding access without safeguards “could expose patients to serious, preventable harm.”
Under the policy, the AMA will also work with federal agencies, state medical boards and state boards of pharmacy to enforce strict oversight and pursue swift enforcement actions against compounding pharmacies, direct-to-consumer telehealth platforms and online dispensaries distributing unapproved peptide formulations that haven’t gone through FDA review. The group said it is committed to making sure physicians, other healthcare professionals and the public are aware of the safety risks, lack of efficacy data and lack of FDA oversight.
The AMA didn’t name the specific policy it wants rescinded, but its call comes less than two weeks after HHS said it doesn’t intend to take enforcement action against pharmacies that compound six unapproved peptides, including BPC-157 and TB-500, if they meet a set of conditions. Patient safety groups ECRI and ISMP had warned against an FDA advisory panel’s vote to relax restrictions on the peptides, and patients who say they were harmed by peptides have said their accounts are being drowned out.
