Nearly a year after removing its strongest warning label from estrogen products, the U.S. Food and Drug Administration wants to make a potentially life-saving hormone treatment for menopausal women available over the counter, USA TODAY has learned.
Dr. Dorothy Fink, the former acting U.S. Secretary of Health and Human Services, told USA TODAY in an exclusive interview that some types of vaginal estrogen could become available without a prescription. It could be available as soon as mid-2027, according to a source familiar with the timeline but not authorized to speak publicly.
To change from a prescription drug to one available to consumers over the counter, the FDA will need evidence that consumers can use the product safely and effectively without
the supervision of a physician or health professional, HHS announced Oct. 30.
It is a policy change that Fink says could save lives.
Vaginal estrogen, a low-dose treatment applied directly to the vaginal tissue as a cream or inserted into the vagina as a ring or tablet, can reduce potentially deadly urinary tract infections in menopausal womenby more than half, studies consistently have shown.
Menopause increases the risk of UTIs because declining estrogen changes the tissue and bacteria of the vagina and urinary tract, making it easier for harmful bacteria to grow. In older women, those infections are also more likely to spread to the bloodstream, causing sepsis, organ failure and death.
“It’s heartbreaking that women are dying from urinary tract infections that lead to sepsis,” Fink, an endocrinologist and now deputy director of the National Institute of Child Health and Human Development, says. “Women should not be dying of urinary tract infections.”
A USA TODAY investigation on Sept. 22 showed how the FDA kept the warning on vaginal estrogen for more than two decades, even as medical associations such as the American Urological Association recommended it for years to menopausal women with recurring UTIs.
Since the story published, USA TODAY has heard from thousands of menopausal women. Many said that despite recurring UTIs, their physicians never prescribed vaginal estrogen. Others shared their own stories of losing loved ones to sepsis from urinary tract infections.
Dr. Barry Zisholtz, a senior advisor to the director of the Centers for Disease Control and a urologist who has worked with the FDA to make vaginal estrogen more accessible, says studies are underway to get the medication approved without a prescription.
"We want to be a little more proactive and prevent UTIs and the possibility of sepsis in women in menopause," he told USA TODAY. "We need to help make the medication more accessible to women."
Up until February, the FDA required a warning label on vaginal estrogen and other estrogen products, warning of increased risks of breast cancer, cardiovascular disease and the potential for dementia. This warning stemmed from a misinterpretation of the influential Women's Health Initiative in 2002, scaring doctors from prescribing vaginal estrogen and other medications and taking women off treatment. It contributed to decades of missed opportunities to prevent serious – sometimes fatal – menopause-related health problems for two generations of women.
HHS announced in November of 2025 that it would no longer require warning labels for estrogen products. By February 2026, the new labelsfor systemic estrogen therapy, progesterone, a pill combining estrogen and progesterone, and topical vaginal estrogen were approved. The FDA also removed the outdated warnings regarding cardiovascular disease, breast cancer, and probable dementia from estradiol transdermal patches on Oct 30.
This latest action comes amid a growing attention to menopause in Washington, D.C.
President Donald Trump established the Women’s Health Division and a White House Women’s Health Task Force aimed at overhauling the federal government’s approach to women’s health, including menopause, Oct. 19.
In September, the U.S. Senate Special Committee on Aging held the first congressional hearing on the issue. The Food and Drug Administration convened a meeting of physicians and experts to discuss the benefits of testosterone for women. And HHS also met with drugmakers about producing more estrogen patches.
On Sept. 24, Fink met with public health officials from the FDA and Centers for Disease Control and leaders of some of the biggest medical associations to discuss how to increase the use of vaginal estrogen in menopausal women and reduce the use of antibiotics.
"The most important policy decision that the government has ever made for women's health was removing the black box warning from estrogen. For so long, women have suffered without answers and without options when it comes to hormones," Fink says.
It’s not enough to simply remove the label, Fink says. “We need to educate women about it. Recurrent urinary tract infections should not be accepted as an inevitable part of aging when we have something that is so effective the way vaginal estrogen is.”
Switching a drug from prescription to over the counter can increase access. But it also can sometimes inhibit use if health insurance doesn’t cover it, says Jennifer Weiss-Wolf, executive director of the Birnbaum Women's Leadership Center at New York University. Policy changes, such as improving Medicare’s prescription coverage, she suggests, could be another way to increase use.
The FDA has acknowledged that many women are not able to get their estrogen patches, and its leaders are working with six manufacturers to increase supply. "We cannot tolerate manufactures claiming reforms are leading to the shortages," Weiss-Wolf said.
The FDA said it continues to work with all six manufacturers of FDA-approved estradiol transdermal patches to increase production. Production has doubled over the last 12 months, the FDA announced Oct. 30.
Only about 1-in-10 menopausal women covered by Medicare uses vaginal estrogen, according to records reviewed by USA TODAY. The treatment remains underused even as UTIs send older women to hospitals and cost Medicare billions of dollars each year.
Increasing access to vaginal estrogen and educating more physicians now is vital, says Dr. Mark Edney, a urologist who leads public policy for the American Urological Association. This includes emergency room physicians and family care doctors who often treat women for UTIs.
Many medical associations, such as the AUA, the Menopause Society and the American College of Obstetricians & Gynecology, recommend vaginal estrogen for menopausal women with recurring UTIs, pain during sex, vaginal dryness, or increased urinary frequency − all symptoms of menopause.
“We can’t wait for the government here. We can start now,” Edney says.
In September, the association shared with its members the stats from a peer-reviewed study of nearly 2 million women with recurrent UTIs that provides striking new evidence of its potential benefits. Researchers reviewing medical records from 2017 through 2025 found that women 55 and older who were prescribed vaginal estrogen were about half as likely to be hospitalized with a UTI as those who were not. Their recorded rates of sepsis and death were roughly one-fifth as high.
The study was observational, not a randomized clinical trial, so it cannot prove that vaginal estrogen alone produced those differences — or that the medication would have prevented any individual woman's death. But the findings build upon decades of research showing that vaginal estrogen can reduce recurrent UTIs in menopausal women.
The AUA also is working with EPIC, the largest electronic healthcare record system, to alert physicians when one of their patients meets the guidelines for treatment.
"This will ensure that every physician, whether in the emergency room or a primary care doctor, is up to date on the latest guidelines," says Dr. Elise De, a urologist and lead researcher on the UTI and sepsis study. "It's one thing to have guidelines, but we need to get them to everyone."
Laura Trujillo is a national columnist focusing on health and wellness. She is the author of "Stepping Back from the Ledge: A Daughter's Search for Truth and Renewal" and can be reached at ltrujillo@usatoday.com.
This article originally appeared on USA TODAY: Women could soon buy this life-saving drug over the counter | Exclusive
