Federal Agencies Announce Key Healthcare Policy Changes, Including Gene Therapy Guidance, Peptide Compounding Rules, and Menopause Treatment Label Updates

Multiple federal health agencies have announced significant policy changes. The FDA released draft guidance allowing developers of patient-specific genome editing therapies to add new variants to existing approvals without new clinical trials under certain conditions. The Centers for Medicare & Medicaid Services (CMS) is expanding its Cell and Gene Therapy Access Model. The Department of Health and Human Services (HHS) introduced an interim policy permitting state-licensed pharmacies and physicians to compound certain peptides without FDA action, aiming to deter the use of unregulated overseas products. Additionally, the FDA approved updated labeling for three more menopausal hormone therapy products, removing outdated black-box warnings related to cardiovascular disease, breast cancer, and dementia, following a similar action in February 2026.