FDA Commissioner Dr. Makary on lifting HRT warnings: 50M women haven't experienced the benefits
What this video covers
In this CNBC “Squawk Box” interview, then-FDA Commissioner Dr. Marty Makary defends one of his signature policy moves: the FDA’s decision to strip long-standing black-box warnings from hormone replacement therapy (HRT) products. Makary argues that the warnings — added after the 2002 Women’s Health Initiative study linked hormone therapy to cancer and stroke risk — have kept tens of millions of women from treatment he says is life-changing.
Makary puts a number on the damage: “Fifty million women since that study 23 years ago have been denied or never offered or talked out of the life changing lifesaving benefits of hormone replacement therapy — including my mom,” he said at the agency’s press event the day before this interview. He argues that doctors are wrongly taught menopause is mild and brief, when in fact symptoms affect over 80% of women and last an average of eight years. The FDA had convened an expert panel in July and opened a public docket that drew nearly 3,000 comments before making the change.
The interview also carries the pushback. The American College of Obstetricians and Gynecologists said it has long encouraged reevaluating warnings on low-dose vaginal estrogen, but considers systemic products — pills and patches — a different case, and warned that systemic estrogen “is not without risk.” Other doctors criticized the FDA’s expert panel as deviating from the agency’s usual rigorous process. Makary’s claims about HRT’s benefits are presented as his position; the site does not offer medical conclusions.
Key points
- Makary argues the 2002 Women’s Health Initiative study overstated HRT risks and that subsequent research shows the therapy can reduce heart disease when started earlier.
- He claims roughly 50 million women have been denied or talked out of HRT’s benefits over the 23 years since the study.
- He disputes medical-school teaching that menopause is mild and short, arguing symptoms are severe and debilitating for many women and average eight years.
- The FDA’s process included a July expert panel and a public comment docket — but critics say the panel lacked the rigor of the agency’s standard approach.
- ACOG’s response split the issue: supportive of reexamining low-dose vaginal estrogen labels, but cautious on systemic estrogen products, which it says require individualized risk conversations.
- Makary frames the label change as removing an “unnecessary barrier” to shared decision-making between patients and clinicians — not as a declaration that HRT is risk-free.