Yes, we still need to protect mifepristone

But at least there was an advancement this week in menopause care.

Dr. JoAnn V. Pinkerton speaks at a July Food and Drug Administration expert panel on hormone replacement therapy in menopause.

A pair of recent headlines about women’s health policy advances at the Food and Drug Administration right before the federal shutdown sounded almost … reasonable? Even promising?

Let’s take a closer look.

Abortion. The FDA caused a stir last week when it approved a new, generic version of mifepristone. The abortion medication, now celebrating its 25^th anniversary on the market after receiving FDA approval in September 2000, is the most relied-on method for safely, effectively, and privately terminating a pregnancy.

Many mainstream news outlets made it sound as if the FDA was doing an about-face, given the Trump administration’s steady erosion of abortion access.

But the latest move really just amounted to a mandatory box check. For any already FDA-approved medication, the agency has no choice but to greenlight a generic version if it is identical to the brand-name drug. The White House said as much in its press conference.

So, is this good news? Well, somewhat. More pills on the market (and perhaps at a more affordable price) mean more available options for consumers. At least for now.

It certainly infuriated abortion opponents. “I have lost confidence in the leadership at FDA,” Sen. Josh Hawley (R-Mo.) complained on X. House Republicans demanded Health and Human Services Secretary Robert F. Kennedy Jr. summarily fire the team responsible for the approval as part of shutdown reduction-in-force evaluations.

Former Vice President Mike Pence joined the fray, calling the approval “a complete betrayal of the pro-life movement that elected President Trump. Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would expand access to abortion, as he has done today.”

But here is why that’s all just blowing smoke: The Trump administration has already taken bold swipes at mifepristone—despite its status as one of the most studied medications in modern medicine—with HHS and the FDA announcing a forthcoming “safety review,” which likely will rely on a recent report replete with flawed data and false claims.

Over at Jessica Valenti’s Abortion, Every Day Substack, Mini Timmaraju, president of Reproductive Freedom for All, made the case that this is gaslighting, pure and simple, a way for the Trump administration to “take credit for being reasonable and moderate simply for letting the FDA do its routine work—even as they’re laying the groundwork to gut access.” Kiki Friedman, CEO of reproductive telehealth platform Hey Jane, summed up the meta-aspect of the moment: “It stands at the same crossroads as vaccines, birth control, prenatal vitamins, and even acetaminophen—all essential, lifesaving health measures suddenly cast into doubt. That’s why protecting mifepristone matters now.”

Menopause. The FDA also made waves over menopause hormone treatment, which has become an increasingly hot topic in women’s health. Last week, FDA Commissioner Dr. Martin Makary told CNN that the agency expects to soon eliminate “black box” labeling that has long deterred usage of certain medications, especially safe-for-all local vaginal treatments. “It’s really a tragedy. It’s maybe one of the greatest screw-ups of modern medicine,” he said.

He is not wrong. Medical experts and clinicians uniformly agree that the inaccurate and overstated warning has led to unnecessary fear and untreated symptoms.

The FDA held a public briefing on the matter this summer, covered by a Contrarian article that unpacked the decades-old debate—from the 1970s, when the FDA first issued its mandate, to the aftermath of the Women’s Health Initiative (WHI) in 2002. When the WHI incorrectly linked a specific formulation of systemic menopause hormone treatment to elevated risk of breast cancer among all users, the FDA adopted the strictest labeling format and an across-the-board warning of risks of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.

At the July panel, Dr. JoAnn V. Pinkerton, professor of obstetrics and gynecology at the University of Virginia School of Medicine, urged, “I am begging the FDA, and all of us are begging, please remove the box label. And please stop harming women.”

Urologist Dr. Rachel Rubin shared, “I’m here for a personal reason. Honestly? Your label tried to kill my mother.” She described how an emergency medical team refused local vaginal estrogen to her mother – comatose, immunocompromised, and in danger of going into urosepsis – and the urgent advocacy required, not only with the doctors but also the pharmacy, which refused to dispense the prescription. Rubin is part of a team that published a 2024 report showing that if Medicare patients regularly received vaginal estrogen, the program could save billions of dollars per year.

Over a decade ago, a group of leading physicians filed a petition to challenge the FDA requirement, which the agency denied in 2018. And now, thanks to a fresh push from a burgeoning menopause advocacy movement, there is momentum to reverse course and take action. (As someone involved in this campaign in my individual capacity, I can assure readers the demand is not coming from industry, nor does it reflect a fringe position.)

All told, these are tough times for speech, for science, for truth. As for the FDA? I guess a stopped watch can be right once a day.

Jennifer Weiss-Wolf is executive director of the Birnbaum Women’s Leadership Center at NYU School of Law. She also leads strategy and partnerships at Ms. Magazine.

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