Sen. Kirsten Gillibrand, D-New York, is calling for accountability from the Food and Drug Administration as women struggle to fill estrogen patch prescriptions more than a year into supply problems.
Demand has increased for the popular menopause medication after the FDA’s removal of the black box warning label on estrogen products.
Experts say demand will go up with the American College of Obstetricians and Gynecologists’ recently announced new guidelines for hormone replacement therapy, which will increase the number of women eligible for treatment.
“Estradiol patches are a first line, widely used, and highly effective treatment for managing menopause symptoms, and FDA should be doing everything in its power to make sure this therapy is available to all women who need it,” Gillibrand told USA TODAY. “This is an urgent women’s health priority, and I will not rest until we have answers.”
Gillibrand is sending a letter to the FDA on Oct. 21 demanding that the agency share its plan to make estrogen patches available, including enacting emergency measures. She shared an advance copy of the letter with USA TODAY.
The agency has acknowledged that women are struggling to find patches, but the FDA has not labeled it as a shortage, which could trigger the agency to speed up reviews to allow manufacturers to use new facilities, help them resolve supply issues and in some cases even allow the compounding of drugs.
Health and Human Services Secretary Robert F. Kennedy Jr. met with physicians and manufacturers to increase access to estrogen patches and teach physicians other options, such as estrogen gels and sprays, on Sept. 15.
USA TODAY has reached out to Kennedy and the FDA for comment.
In the meantime, the FDA is telling women to talk to their pharmacist or doctor about options.
“Passive monitoring and generic advice fail to adequately mitigate a nationwide manufacturing deficit,” Gillibrand wrote in the letter, signed by Sens. Tammy Duckworth, D-Illinois, and Adam Schiff, D-California.
Why Women Are Still Going Without
Women say they are frustrated that they are still struggling to get access to the medication they need. The American Society of Health-System Pharmacists, which represents more than 65,000 pharmacists, documents that there are almost 20 estrogen patch formulations impacted by the shortage, double the number from earlier this year.
How the Black Box Warning Shaped Demand
Hormone replacement therapy plummeted from 27% of menopausal women in 1999 to 5% in 2020, according to the National Institutes of Health.
The FDA’s black box warning kept many women away from hormone replacement therapy after a 2002 Women’s Health Initiative study linked it to a higher risk of breast cancer, heart attacks and strokes in postmenopausal women. It was recognized later that the risks were mostly found in women who were older when they started hormone therapy.
As more physicians became certified in menopause care in the past decade, use of hormone replacement therapy increased. Estradiol patch prescriptions went from about 594,000 in June 2024 to 1.6 million in May 2026, according to HealthVerity, a data company. Mark Cuban, owner of CostPlus drugs, said in a recent podcast with Dr. Mary Claire Haver on menopause that patch volume has increased at least tenfold in the past few years.
The shortage was getting worse even before the FDA changed its labeling, Kathleen Jordan, the chief medical officer and cofounder of Midi, a women’s telehealth menopause provider, told USA TODAY earlier this year. “The problem isn’t an increase in demand of the patch, the problem is the manufacturers. The demand is only going up as access to care is improving. It could take years to solve it.”
What Women Can Do If They Can’t Find the Patch
Sharon Malone, an obstetrician and gynecologist and medical adviser for Alloy, says women should not skip treatment, but also not panic. “We want them to remain symptom-free,” she says.
Physicians offer these suggestions for patients grappling with the ongoing shortage:
- Try local and mail-order pharmacies as stock varies.
- Try estrogen spray or gel, which also can be applied on the arm or thigh. Ask your physician for a prescription. Both spray or gel allow providers the flexibility to change doses without changing the prescription.
- If women can take oral estrogen (some women with blood clots or other health issues cannot), it is a good temporary solution.
- If your pharmacy can’t fill your patch, report it to the FDA at [email protected].
- Haver also suggests that women alert the manufacturer of the drug they are seeking, sharing their Zip code and asking for a resupply date.
Reporting by Laura Trujillo, USA TODAY / USA TODAY
USA TODAY Network via Reuters Connect
Add a Comment