Updated October 30, 2026, 5:13 p.m. ET
Nearly a year after removing the strongest warning label for estrogen products, the U.S. Food and Drug Administration wants to make a potentially life-saving hormone treatment available over-the-counter for postmenopausal women, USA TODAY has learned.
Dr. Dorothy Fink, former acting U.S. Secretary of Health and Human Services, told USA TODAY in an exclusive interview that certain types of vaginal estrogen may be available without a prescription. It could be available as early as mid-2027, according to a source familiar with the schedule but who was not authorized to speak publicly.
To replace a prescription drug with an over-the-counter drug, the FDA will need evidence that consumers can use the product safely and effectively without the supervision of a doctor or health care professional, HHS announced Oct. 30.
It’s a policy change that Fink says could save lives.
Vaginal estrogen, a low-dose treatment applied directly to vaginal tissues as a cream or inserted into the vagina as a ring or tablet, can reduce life-threatening urinary tract infections in postmenopausal women by more than half, consistent studies show.
Menopause increases the risk of urinary tract infections because lower estrogen changes the tissues and bacteria in the vagina and urinary tract, making it easier for harmful bacteria to grow. In older women, these 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,” said Fink, an endocrinologist and now deputy director of the National Institute of Child Health and Human Development. “Women should not die from urinary tract infections.”
A Sept. 22 USA TODAY investigation showed how the FDA maintained the warning on vaginal estrogen for more than two decades, even as medical associations such as the American Urological Association recommended it for years for postmenopausal women with recurrent UTIs.
Since the story was published, USA TODAY has heard from thousands of postmenopausal women. Many said that despite recurring UTIs, their doctors never prescribed vaginal estrogen. Others shared their own stories of losing loved ones to sepsis from urinary tract infections.
Dr. Barry Zisholtz, 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 drug approved without a prescription.
“We want to be a little more proactive and prevent UTIs and the possibility of sepsis in postmenopausal women,” he told USA TODAY. “We need to help make medicines more accessible to women.”
Until February, the FDA required a warning label on vaginal estrogens and other estrogen products, warning of increased risks of breast cancer, cardiovascular disease and the potential for dementia. The warning stems from a misinterpretation of the influential 2002 Women’s Health Initiative, which discouraged doctors from prescribing vaginal estrogen and other medications and stopping women from all treatment. This has contributed to decades of missed opportunities to prevent serious – sometimes fatal – health problems linked to menopause for two generations of women.
HHS announced in November 2025 that it would no longer require warning labels for estrogen products. In February 2026, new labels for systemic estrogen therapy, progesterone, a combined estrogen and progesterone pill, and topical vaginal estrogen were approved. On October 30, the FDA also removed outdated warnings about cardiovascular disease, breast cancer, and probable dementia from estradiol transdermal patches.
This latest action comes amid growing attention to menopause in Washington, D.C.
On October 19, President Donald Trump created the Division of Women’s Health and a White House Women’s Health Task Force aimed at rethinking the federal government’s approach to women’s health, including menopause.
In September, the U.S. Senate Select Committee on Aging held the first congressional hearing on the issue. The Food and Drug Administration has called a meeting of doctors and experts to discuss the benefits of testosterone for women. And HHS has also met with drugmakers about producing more estrogen patches.
On September 24, Fink met with public health officials from the FDA and the Centers for Disease Control, as well as leaders of some of the largest medical associations, to discuss how to increase the use of vaginal estrogens in postmenopausal women and reduce the use of antibiotics.
“The most important policy decision the government has ever made for women’s health was removing the black box warning about estrogen. For so long, women have suffered without answers and without options when it comes to hormones,” Fink said.
It’s not enough to just remove the label, Fink says. “We need to educate women about this. Recurrent urinary tract infections should not be accepted as an inevitable part of aging when we have such an effective product as vaginal estrogen.”
Switching from prescription to over-the-counter medications can increase access. But it can also sometimes hinder consumption 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 prescription coverage, she suggests, could be another way to increase utilization.
The FDA has recognized that many women are unable to get their estrogen patches, and its leaders are working with six manufacturers to increase supply. “We cannot tolerate manufacturers claiming that reforms lead to shortages,” Weiss-Wolf said.
The FDA said it continues to work with the six manufacturers of FDA-approved estradiol transdermal patches to increase production. Production has doubled in the past 12 months, the FDA announced October 30.
Only about 1 in 10 postmenopausal women covered by Medicare use vaginal estrogen, according to records reviewed by USA TODAY. The treatment remains underutilized even though UTIs send older women to the hospital and cost Medicare billions of dollars each year.
Increasing access to vaginal estrogen and training more doctors is now critical, says Dr. Mark Edney, a urologist who directs public policy for the American Urological Association. This includes emergency room doctors and family 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 estrogens for postmenopausal women with recurrent UTIs, pain during sex, vaginal dryness, or increased urinary frequency—all symptoms of menopause.
“We can’t wait for the government to come. We can start now,” says Edney.
In September, the association shared with its members statistics from a peer-reviewed study of nearly 2 million women with recurrent UTIs, which provides striking new evidence of its potential benefits. Researchers examining medical records from 2017 to 2025 found that women 55 and older who were prescribed vaginal estrogen were about half as likely to be hospitalized for a UTI as those who were not. Their recorded sepsis and death rates were about a fifth of those.
This was an observational study and not a randomized clinical trial. So she can’t prove that vaginal estrogen alone produced these differences — or that the drug would have prevented a woman’s death. But the findings build on decades of research showing that vaginal estrogen can reduce recurrent UTIs in postmenopausal women.
AUA also works with EPIC, the largest electronic health records system, to alert physicians when one of their patients meets treatment guidelines.
“This will ensure that every doctor, whether they are in the emergency room or a primary care physician, is up to date with the latest guidelines,” says Dr. Elise De, a urologist and principal investigator of the UTI and Sepsis Study. “It’s one thing to have guidelines, but we need to convey them to everyone.”
Laura Trujillo is a national health and wellness columnist. 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.
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