Comment: What promise to ‘review the data’ could mean for health

By Lisa Jarvis / Bloomberg Opinion

Anyone listening to Thursday’s confirmation hearing for Marty Makary, President Trump’s pick to lead the Food and Drug Administration, should have heard alarms go off during discussion of a topic affecting access to health care for millions of Americans: his approach to regulation of the abortion pill mifepristone.

Makary mostly sidestepped direct answers to senators’ questions. But he sounded prepared to relitigate more than two decades of safety data on the drug, which is part of a two-pill regimen of medication abortion that has been approved since 2000.

He repeatedly told senators he would “review the data” on mifepristone. However, that review will determine women’s access to the drug, and Makary’s answers made it apparent that he’s more likely to follow Trump and the political winds on abortion and other critical areas he would oversee at the FDA, including vaccine regulation.

When the Supreme Court overturned Roe v. Wade in 2022, allowing state abortion bans to proliferate, mifepristone became the epicenter of the fight over reproductive rights. Part of Makary’s role as FDA commissioner is deciding how the pill can be prescribed and dispensed. For two decades, FDA guidelines required that it be dispensed in person; by a doctor. In 2021, regulations were loosened to allow it to be prescribed via telehealth and sent by mail-order delivery or pharmacy pick-up. Pharmacies must be specially registered to dispense the medication, and the FDA has maintained a program that requires monitoring its safety.

That flexibility in accessing the pill, in line with so many other medications we take, has dramatically increased its use for women across the country. Of course, it has been vital for women in states where abortion is banned, but new data from the Guttmacher Institute shows its importance in states where the procedure is legal, too. In California, for example, it accounts for 71 percent of abortions. It’s even more critical to health care access in rural states with few providers, like Wyoming and Montana, where it represented 95 percent and 85 percent of abortions, respectively, according to the Guttmacher data.

Straight out of the gate, Sen. Bill Cassidy, R-La., a physician who chairs the Senate Committee on Health, Education, Labor and Pensions, asked Makary if he would reinstate the in-person dispensing and safety reporting requirements for mifepristone.

Makary told Cassidy that he had “no preconceived plans on mifepristone policy, except to take a solid hard look at the data” and to meet with the internal FDA experts who have reviewed it. Upon more pointed questioning from Sen. Tammy Baldwin, D-Wis., who asked for a plain yes or no answer to whether he would maintain current access to the pill, Makary again hedged. “I can’t prejudge data without looking at it,” he said.

That was the first alarm bell Makary set off. As he knows, data establishing mifepristone’s safety has existed for years. He later admitted that he was familiar with the evidence, which includes studies related to telehealth access. And yet he kept returning to this idea that the FDA’s data needed to be reviewed, twice mentioning that he might find, “for example, a drug-drug interaction.” That was the second alarm bell.

The third one came when Makary referred to the notion that pills dispensed outside of a physician’s office might be used to coerce someone into an abortion.

All of this echoed the position taken by Health and Human Services Secretary Robert F. Kennedy Jr. during his confirmation hearings, where he said that Trump had asked him to “review the data” on the drug. Kennedy referred to since-retracted studies on the pill to sow doubt in its safety.

This idea that the data needs to be reexamined on topics that are inconvenient or uncomfortable for the Trump administration has the potential to cause real harm to millions of women. However, it should also raise concerns about other areas where science might be manipulated to fit a political agenda.

There were hints of this in Makary’s hearing. For example, several senators asked about the recent cancellation of a meeting of the FDA’s vaccine advisory panel, which was expected to publicly discuss the composition of next fall’s flu vaccine. Makary refused to say he would reconvene the committee as soon as he was appointed and instead said he would “immediately reevaluate” the committee’s activities and determine which needed to continue.

To paraphrase Sen. Patty Murray, D-Wash.: What exactly are you reevaluating?

To be fair, among the many highly controversial public health agency nominees, Makary has been the least controversial; it’s a low bar. And it’s worth noting he shares the other candidates’ contrarian views about covid. Still, he has been more forthcoming than the other nominees about his potential conflicts of interest and voluntarily divested his positions in areas of industry he might soon oversee. And there’s an overall sense that he isn’t going to stray wildly from conventional regulatory science when it comes to approving new drugs and devices.

However, his answers on contentious issues show a willingness to follow the whims of his boss instead of science. That starts with mifepristone, but we should worry about where it ends; and what that will mean for Americans’ health.

Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News. ©2025 Bloomberg L.P., bloomberg.com/opinion