Prime Highlights
- FDA Commissioner Marty Makary denounces women’s health research under-funded and controlled by a male-dominated medical establishment.
- The FDA considers withdrawing “black box” warnings for menopause hormone therapy based on outdated and misleading risk information.
Key Facts
- An FDA advisory panel voted to reconsider hormone therapy labels for menopause treatment.
- The original 2002 study criticizing hormone therapy with serious health consequences has been refuted by newer, more precise studies.
Key Background
FDA Commissioner Marty Makary also floated more concern about the endemic underfunding and lack of priority for issues concerning women’s health. He argued that healthcare research had classically been constructed based on a male body function framework, thereby overlooking disorders like menopause, hormonal diseases, and other health complications that specifically occur among women. Makary argues that this deficit has translated into millions of women in the country having less access to quality interventions and information.
One of the highest-profile issues to be argued is hormone replacement therapy (HRT) at menopause. In 2002, a highly publicized trial established disastrous health effects of HRT such as breast cancer and heart disease. This resulted in the addition of “black box” warnings to hormone therapy medications. Nevertheless, later studies have revealed that these effects are far less drastic than initially predicted, especially in younger women or limited term use.
In July 2025, the FDA met with a panel of experts to re-examine these warnings and consider newer scientific evidence. The panel concluded that the warnings exaggerate the risks of hormone therapy and discouraged many women from taking drugs that could greatly improve their quality of life. Makary has noted that the FDA now sees revamping or eliminating such labels, in consideration of updating public health recommendations in accordance with newer evidence.
This re-prioritization of women’s health is just one of the various FDA plans for putting sex-specific research on the agenda, allocating additional resources to medical studies performed on women, and providing woman-specific treatments. Makary’s appointment is a move toward closing long-existing gaps in medical research and providing equal healthcare solutions.
