U.S. Food and Drug Administration Commissioner Marty Makary criticized the longstanding neglect of women’s health in medical research and funding, citing a male-dominated culture within the healthcare system as a central cause.
“It does feel like the system just doesn’t think specifically about the very particular needs of women’s bodies and doesn’t do enough research into this,” Makary said during The Conversation podcast hosted by POLITICO White House Bureau Chief Dasha Burns. The interview was taped on Wednesday.
Makary, who has made women’s health a personal priority during his tenure, has pushed to reexamine the medical community’s approach to hormone therapy.
Earlier this month, he convened an FDA advisory panel focused on treatment options for menopausal women. The panel discussed broader strategies for care that move beyond simply managing symptoms and emphasized the importance of updated education and therapeutic options.
A major point of contention is the warning labels on hormone replacement therapy (HRT) products. Makary pointed to longstanding misconceptions stemming from a 2002 study by the Women’s Health Initiative (WHI), which raised alarm about increased risks of cancer and stroke associated with HRT. The study was prematurely halted, and its findings significantly influenced public opinion and clinical guidelines for over two decades.
“We got hormone replacement therapy wrong for 22 years, scaring women, saying that it increases your risk of dying of breast cancer when no clinical trial has ever supported that finding,” Makary said. “So look, we wanna have a healthy discourse and debate.”
The FDA panel recommended removing the so-called black box warnings on menopause treatments, arguing that they overstate potential dangers and may deter women from beneficial therapies.
While Makary has expressed personal support for removing the warnings, he emphasized that any regulatory change must follow a transparent and collaborative process. The FDA is currently gathering public comments and feedback from stakeholders before making a final decision.
“I wanna do this as a team,” Makary said. “I’ve got my own opinion on it, which I think it’s not a secret, but the way to do these things is to go through the proper process—get all the public input, get it summarized, listen to the stakeholder groups, and then have a group make that decision.”
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