The FDA’s ‘data guy’ should trust the data on the abortion pill 

At a time when abortion access is under attack, Food and Drug Administration Commissioner Marty Makary’s pledge to reexamine the safety of medication abortion isn’t just pointless — it’s dangerous. While the FDA has yet to announce when this review will take place or what it will entail, it’s clear that Makary’s decision is part of a strategy to stoke fear and distrust of abortion pills and further prevent patients from making their own decisions about their health. 

Mifepristone, the abortion pill, is one of the most studied drugs on the market. Since its approval 25 years ago, 7.5 million patients across the country have used it safely. Study after study shows that it is effective and low-risk and can be life-saving.

This is not an abstract debate for us. One of us is a public health scientist who has spent two decades studying the safety and accessibility of abortion, leading large-scale studies that have shaped national conversations and informed policy. The other runs a telemedicine clinic that has provided medication abortion by mail after an online consultation to tens of thousands of patients across the country, many of whom would otherwise face long travel, high costs, delayed abortion or no options at all. Together, we bring both data and lived experience to this issue. We don’t just know the research — we see the real-life consequences of abortion policy every day.

When the FDA approved mifepristone in 2000, it tacked on restrictions widely acknowledged as politically motivated, not medically necessary. Only doctors could prescribe it, and patients had to pick it up in person at a clinic or hospital — no pharmacies, no mail. These hurdles had little to do with safety and everything to do with stigma and paternalism.

After two decades of peer-reviewed research and clinical experience, the FDA rolled back those restrictions, paving the way for those seeking an abortion across the country to access care via virtual telehealth services. Today, medication abortion is the most common method of abortion in the U.S., accounting for more than 63 percent of abortions.

In 2024, the University of California San Francisco led a landmark study that found this model is not only as effective and low-risk as in-person medication abortion care, but critical for expanding access. It reduces stigma and allows people to get care affordably and privately, and without the burden of travel.

Access is everything. For young people, rural communities and those struggling to make ends meet, telehealth can be the difference between getting care or not. Since the fall of Roe v. Wade, states where abortion is still legal have seen surging demand. Telehealth helps meet that need, reducing wait times and letting people get care earlier in pregnancy. In fact, a newly released report states that one in four abortions in the U.S. happens via telehealth.

Medication abortion is safe. Yet after more than two decades of following the science and expanding access to mifepristone, the FDA is suddenly casting doubt on it.

Makary, who proudly calls himself a “data guy,” should have no trouble acknowledging that the science behind mifepristone is rock solid — and it hasn’t changed. In fact, Makary’s own agency released a new report on adverse events for mifepristone less than six months ago, proving the drug’s exceptional track record yet again, including when it is dispensed through telehealth.

Decades of peer-reviewed research prove this medication is not just safe but safer than most prescription drugs and even many over-the-counter ones. Millions of Americans have relied on medication abortion to make deeply personal decisions about their own bodies — and that reality isn’t going anywhere.

We don’t need another round of endless reviews. The evidence for medication abortion’s safety is overwhelming and crystal clear. The FDA’s job is simple: follow the science, not second-guess it. Anything less will risk standing in the way of Americans’ health and well-being.

Ushma Upadhyay, Ph.D., MPH is a professor at the University of California, San Francisco in the Department of Obstetrics, Gynecology, and Reproductive Sciences. Kiki Freedman is co-founder and CEO of Hey Jane.