Ask the FDA to declare an estradiol patch shortage

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The Issue

Dear FDA and elected officials,

We are asking you to press the FDA to declare a drug shortage of the medically necessary estradiol (estrogen) patch.

We are the patients living this shortage - and we are done being dismissed.

Women's health has a long history of being an afterthought in this country. Women were not even required to be included in clinical trials until 1993. That legacy of dismissal did not end there.  It is happening again, right now, with estradiol patches.

Part of what's happening isn't a coincidence. In November 2025, the FDA moved to remove the black box warning that had been on estrogen products for over two decades; a warning the agency's own leadership now says was based on an outdated, misread interpretation of decades old data.

That decision opened the door for far more women to be prescribed estradiol. And it should have. But, demand surged faster than manufacturing could keep up, and now the same women this policy was meant to help are the ones absorbing the consequences of a shortage no one prepared for.

Estradiol replacement is not optional, and it is not cosmetic. It is the standard of care for millions of women managing perimenopause and menopause, and for many of us, it is a medical necessity not a lifestyle choice.

Patients have already submitted reports. Doctors have already submitted reports. And the response has consistently been the same: "product available." We can assure you, that is not the reality on the ground.

What we are experiencing is not a technicality of supply. It is patients being switched between brands without warning, absorption  varying patch to patch, and hormone levels dropping in ways that are measurable on bloodwork not imagined.

 The result is a return of debilitating symptoms: hot flashes, sleep disruption, mood instability, joint pain, and more, in women who had finally gotten stable.

This is the definition of a shortage;  not by paperwork, but by outcome. Patients are not getting consistent access to the medication they were prescribed and stabilized on.

We are not asking the FDA to undo the progress. We are asking them to finish the job, acknowledge the shortage this progress created, and hold manufacturers accountable to meet it.

We have suffered enough.

Sincerely,

The Women of the United States of America

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