FDA Advisory Committee Votes to Add Six Peptides to Drug Compounding List An advisory committee for the U.S. Food and Drug Administration (FDA) voted narrowly to recommend adding six peptides to a list of ingredients that specialty pharmacies can use to create custom medications. The decision, made during a two-day hearing, involves compounds such as BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. The vote is non-binding and requires final approval from the FDA. Robert F. Kennedy Jr., who oversees the agency as Health and Human Services Secretary, has publicly supported the inclusion of peptides, framing restrictions as unnecessary barriers to patient access. The panel rejected a seventh peptide, emideltide, due to insufficient evidence. Proposed as a treatment for narcolepsy and opioid withdrawal, the compound faced criticism for relying on clinical studies that used intravenous administration rather than the proposed subcutaneous route. The FDA highlighted concerns about the lack of robust data, the absence of well-tested treatments for these conditions, and the potential for harmful immune reactions. The rejection underscored a divide between the advisory committee, many of whom run clinics offering peptides, and FDA staff scientists, who unanimously opposed the addition of all six peptides. The vote exposed tensions between the advisory group, appointed under Kennedy’s leadership, and the FDA’s internal reviewers. While the committee members argued that adding peptides to the list could reduce harm by steering patients away from unregulated black-market products, public health advocates and agency scientists warned of dangerous precedents. Dr.#us_food_and_drug_administration #georgetown_university #robert_f_kennedy_jr #fda_advisory_committee #dr_adriane_fughberman
