The FDA Finally Said Yes. Then Left Women Without Estrogen

Written By Maxine Wally

Yes, the FDA Gave Us Permission, But Then Left Us to Fend for Ourselves….

By Jacqueline “Jack” Perez

Let me set the scene.

You spent years being told estrogen was dangerous. Your doctor took you off it. You read the warnings. You believed them. You pushed through the hot flashes, the brain fog, the sleepless nights, the anxiety that arrived uninvited somewhere around 48 and never quite left. You did what you were told.

Then, in November 2025, the FDA removed the black box warnings from hormone replacement therapy products. Warnings in place for more than 20 years, warnings that scared an entire generation of women away from a medication that could have helped them, were finally, officially, acknowledged as overstated. The science had moved on. So had the FDA.

We exhaled. We called our doctors. We got our prescriptions.

And then we went to the pharmacy and were told our estrogen patches were on backorder.

Here is what the data made clear long before the FDA removed those warnings: demand would surge. It wasn't a guess. Prescriptions for estrogen-based therapies had already climbed 86% since 2021. Among women ages 45 to 54, prescribing rates had jumped 184% since 2018. By February 2026, roughly one in 20 women in that age group had an active estrogen prescription. Anyone paying attention could see what was coming.

What happened the moment those black box warnings came off? Prescriptions increased another 20% between July 2025 and February 2026 alone.

The system was not ready, and honestly, it was never going to be. Only five companies manufacture estrogen patches for the entire U.S. market. All five are currently running at full capacity. There is almost no buffer. Here's why: estrogen patches are generic drugs. No patent protection means no pricing power, which means margins are thin, which means no company has a financial incentive to invest in extra manufacturing capacity. Nobody builds expensive new production lines for a drug they can't charge a premium for. Brands like Dotti and Lyllana went on backorder with no clear return date. The American Society of Health-System Pharmacists listed more than 10 estrogen patch products on its drug shortage bulletin by February 2026. One manufacturer, Sandoz, publicly stated that the FDA's November decision had "created unprecedented demand that cannot fully be met at present." That's a polite way of saying: we didn't see the point in preparing for this, and now here we are.

The shortage is international. It's projected to last up to three years.

And the FDA? The FDA has not declared an official shortage.

Read that again.

Women across the country are walking into pharmacies and being told their medication is unavailable. Their doctors are calling around. They're driving to independent pharmacies, splitting doses, switching to formulations that don't work as well for them, or going without entirely. The American Society of Health-System Pharmacists is tracking the shortage. Manufacturers are acknowledging the shortage. Telehealth companies are scrambling to help their patients navigate the shortage.

But the FDA chief, Dr. Marty Makary, told NBC News the demand surge was real—just "not enough to cause a shortage."

Tell that to the woman who stopped sleeping again. Tell that to the one who thought the brain fog was finally behind her. Tell that to the women who had to explain to their doctors why they can't just "try a cream instead" when what they need is the patch they've been on for two years, and their body knows how to use.

The FDA's position is a semantic argument dressed up as a regulatory stance. No official shortage means no formal response. No formal response means no pressure on manufacturers, no expedited approvals for new production lines, no urgency. Meanwhile, women's symptoms are returning while officials debate the paperwork.

We have seen this before. After the Women's Health Initiative study in 2002, millions of women went without hormone therapy for two decades—based on risks that later research showed had been dramatically overstated. The removal of the black box warning was an admission that the system failed us. What's happening now is the same failure, just a different chapter: once again, the people in charge have moved without thinking about what happens next for us.

There's a financial cost to this that no one wants to name. When estrogen levels drop, symptoms return fast. Brain fog. Sleep disruption. Mood crashes. These aren't inconveniences; they are productivity losses, career disruptions, relationship strain. Women in midlife are, by every economic measure, at the peak of their professional and economic power. We are running companies and managing teams, and making consequential decisions while hunting down a medication our doctors confirmed we need. Hormone disruption is not a minor quality-of-life issue. It is a functional impairment. And when the medication that prevents it disappears from pharmacy shelves, the cost doesn't stay with us; it spreads to every household, every workplace, every team we lead.

So what do we do?

For now: ask your doctor about alternatives. Estrogen gels (EstroGel, Divigel) and sprays (Evamist) work the same way–through the skin—and sidestep the supply crunch. Independent pharmacies sometimes have stock that chain pharmacies don't, because their supply chains work differently. Ask about a once-weekly patch as a bridge. Talk to a telehealth provider who specializes in menopause. Companies like Midi Health are in direct conversation with FDA officials right now, advocating for formal recognition of this shortage and expedited manufacturing approvals.

But we also need to be louder than we have been. The FDA responded to the science, eventually. They will respond to organized pressure. The ASHP is tracking this. Midi Health sat down with senior FDA officials in May 2026 specifically to advocate for formal shortage recognition. More of that, please.

We did everything right. We waited for the science to catch up. We waited for the warnings to come down. We showed up at the pharmacy. We are not going to quietly accept being handed a workaround and told to be grateful.

The fight for estrogen didn't end when the black box warning came down. It just moved to the supply chain. The FDA knows we're paying attention now. Let's make sure they feel it.

Jacqueline Perez is the founder and CEO of Kuel Life, a media platform dedicated to normalizing aging for women in midlife and beyond. She writes about all of it—the health crises, the career pivots, the relationships, the reinvention, and the staggering economic power of women the media keeps ignoring.

Sources

Maxine Wally
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