Health and Human Services Secretary Robert F. Kennedy Jr.’s vow to Make America Healthy Again scored another win on Monday.
RFK, Jr. announced the FDA will remove black box warnings from hormone replacement therapy products, reversing a 22-year-old decision that kept millions of women from treatment for menopause symptoms.
Kennedy and FDA Commissioner Marty Makary made the announcement at a press conference at HHS headquarters with more than 200 people in attendance, including Second Lady Usha Vance and Secretary of Labor Lori Chavez-DeRemer.
“For more than two decades, the American medical establishment turned its back on women,” Kennedy said. “Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause. That ends today.”
Black box warnings are the strictest warning the FDA can place on prescription drugs. The FDA applied the warnings to hormone replacement therapy in the early 2000s following a Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis.
“After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even life-saving, treatment,” Makary said.
The warnings caused hormone therapy use among menopausal women to plummet. Prior to 2002, one in four American women used hormone replacement therapy. Today, fewer than one in 20 women use the treatment.
“That’s not progress, that’s neglect, that’s malpractice,” Kennedy said. “We can no longer accept a culture of fear that blocks innovation and keeps patients from proven therapies.”
Makary said a 2002 study known as the Women’s Health Initiative was “misrepresented and created a fear machine.”
The change comes after the FDA publicly reported the flaws in the Women’s Health Initiative study. The average age of women who participated in that study was 63, which is well past when most women go through menopause. The women in the study were also taking a hormone formulation that is no longer commonly prescribed.
The FDA’s own review found that women who started hormone replacement therapy within ten years of menopause and typically before the age of 60 reaped benefits beyond just relief of symptoms like hot flashes and night sweats. Studies show women may reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%. Randomized studies also show women who initiate HRT within 10 years of menopause have a reduction in all-cause mortality.
An analysis of 30 trials with 26,708 women participants reportedly found HRT was not associated with increased cancer mortality. Women who start HRT before age 60 appear to have a decreased mortality risk.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” Kennedy said. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” Makary said. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
Dr. Rachel Rubin, one of the leading physicians behind the announcement, praised the FDA’s decision.
“We have been begging for these changes for decades now, and to have it actually come to fruition is nothing short of revolutionary,” Rubin said.
Monique Yohanan, senior fellow for health policy at the conservative nonprofit Independent Women, said the decision restores balance to women’s health policy.
“For years, risk was overstated and benefit was understated,” Yohanan said. “By aligning labeling with current evidence, FDA is giving physicians and women the clarity they deserve to make informed choices.”
The FDA convened an expert panel in July to discuss the benefits and risks of hormone replacement therapy for women. The panelists urged the agency to remove the warning label.
Consumers will see a different label on the products in several months. Hormone replacement therapy still requires a prescription and women considering it should speak with their doctor about individual risks and benefits.