How safe is it to take abortion pills? The F.D.A., the nation’s authority on drug regulation, says that it’s very safe. But the agency’s judgment is the topic of a sweeping challenge that the Supreme Court will hear tomorrow. The case could curtail Americans’ access to mifepristone, the first pill taken in a two-drug regimen for a medication abortion.
Pills now account for most abortions in the United States. Increasingly, people take the medications at home. About 14,000 medication abortions per month are now prescribed online, with pills sent through the mail.
In today’s newsletter, I’ll explain how the suit against the F.D.A. seeks to shut down this form of access and impose other restrictions. A decision in the plaintiff’s favor would change the landscape of abortion not state by state, like the effects of the 2022 ruling that overturned Roe v. Wade, but across the country.
Post-Roe America
The abortion opponents who sued the government in tomorrow’s case, F.D.A. v. Alliance for Hippocratic Medicine, are frustrated by how common abortion has remained. Since the high court struck down Roe, 16 states have banned or severely restricted the procedure. In those places, some women who would have ended their pregnancies are carrying them to term, as my colleagues Margot Sanger-Katz and Claire Cain Miller have explained. But the total number of abortions across the country has not fallen. It may actually have increased.
That’s in large part because of abortion pills, which the F.D.A. first approved in 2000. “In the six months after the Supreme Court overturned Roe, the rise in the supply of pills outside of clinics significantly made up for the reduction in abortions otherwise,” said Abigail Aiken, a professor of public affairs at the University of Texas at Austin with a new study on the topic. In some states, CVS and Walgreens recently started dispensing mifepristone along with misoprostol, the second abortion pill, in stores with a prescription.
The F.D.A. laid the foundation for these changes. In 2016, it let nurses and others prescribe mifepristone. It also permitted patients to take the pill 10 weeks into pregnancy, extending the limit from seven weeks. In 2021, the F.D.A. allowed providers to send mifepristone by mail, lifting a rule that had required an in-person medical visit. “Study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare,” the F.D.A. said in its Supreme Court brief.
The F.D.A.’s judgment
The plaintiffs in today’s case, a coalition of anti-abortion physicians and medical groups, say the F.D.A. is wrong. They fault the agency’s collection of data and argue that some complications go unreported, creating an incomplete picture of risk. Last year, the U.S. Court of Appeals for the Fifth Circuit agreed, ruling that the F.D.A.’s database of adverse events was “insufficient” and thus its decisions in 2016 and 2021 were invalid.
The F.D.A. says that it is using its standard system for reporting drug complications — and that it has reviewed extensive research showing that mifepristone is safe, including to take at home. Its job, the agency argues, is not to “act based on perfect data, which seldom exists” but rather to “act reasonably based on the information available.” (And in February, a journal retracted two studies highlighting purported risks of mifepristone.)
Because the F.D.A. followed its standard approval process, a victory for abortion opponents could undermine its authority to determine whether any drugs are safe. The case has unsettled the pharmaceutical industry. Congress intended the F.D.A., not the courts, to be the “expert arbiter of drug safety,” drug companies and investors argued in a brief. They said the Fifth Circuit created “an impossibly rigid new standard for drug approval.”
Another question is whether the plaintiffs are even allowed to challenge the F.D.A. As a rule, litigants have to show that they have been harmed by an action to sue over it. The anti-abortion physicians say they may have to provide emergency care to women with incomplete abortions or other complications from taking mifepristone. The Fifth Circuit ruled this was enough, based on the likelihood that it could happen. But Supreme Court precedent rejects a statistical conception of standing.
The plaintiffs also argue that they would be harmed by feeling that they had to help complete an abortion against their conscience. The government says that this conception of harm is hypothetical. The F.D.A.’s regulations for mifepristone, after all, don’t require any doctor to do anything.
What happens next?
If the F.D.A. loses, it’s unclear what will happen. Providers in the U.S. could still prescribe and ship misoprostol, the second abortion pill. Taken in higher doses without mifepristone, misoprostol is 88 percent effective, according to one study; the two-drug regimen is 95 percent effective or more. Misoprostol-only abortions also tend to include more hours of pain and cramping, with more side effects like nausea and diarrhea. So the upshot could be more physical discomfort for American women.
Another possibility is that more people will order the standard combination of mifepristone and misoprostol from foreign suppliers, though that market isn’t really legal.
Whatever the court decides, the future of medication abortion is in the hands of the voters as well. The president decides who runs the F.D.A. The agency has continued or expanded access to mifepristone under the past five presidents. That includes Donald Trump. But with Roe overturned and control of the F.D.A. up for grabs in 2024, there’s much more pressure to restrict abortion pills than there was before.
Related: In states where abortion is legal, doctors are sending abortion pills to tens of thousands of women in states where it is illegal.
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