Food and Drug Administration Commissioner Marty Makary released a set of two episodes of the FDA Direct podcast to discuss the agency's actions on Hormone Replacement Therapy (HRT). The podcast episodes featured discussions with the physicians regarding their work on menopause and HRT. The commissioner and experts generally agreed that HRT offers important benefits and that physicians need more education regarding its use, with Makary criticizing in particular the medical community, the agency, and the media for actions that served to limit access to the treatment based on faulty analyses.
The video for part one is available on X here, and part two is here. The part one transcript is available here, and the part two transcript is available here.
Additionally, the FDA has initiated the removal of "black box" warnings from menopausal hormone replacement therapy products. Specifically, the agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.
Click here for a recent NCPA/Alliance for Pharmacy Compounding joint letter to the FDA on the benefits of menopause hormone therapy.
