How the abortion pill case at the supreme court could undo the FDA

A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.

Despite a more than 20-year track record of safe real-world use, backed up by more than 100 peer-reviewed studies, a group of anti-abortion doctors is seeking to roll back US Food and Drug Administration (FDA) decisions that changed and relaxed some prescribing rules.

Related: The mifepristone case: abortion and the US supreme court meet again

If the doctors succeed, despite contested and in some cases now-retracted evidence of harm, the case could reshape abortion access in the US and have enormous and unpredictable consequences for how drugs are prescribed, regulated and developed.

A ruling in favor of anti-abortion doctors could threaten everything from trust in medicine to specific drugs to the US’s position as the world’s foremost drug innovator.

“I am terrified,” said Juan Hincapie-Castillo, a drug policy researcher, licensed pharmacist and assistant professor of epidemiology at the University of North Carolina. “This case is shifting the whole paradigm of how things could go moving forward.”

Mifepristone was approved by the FDA in 2000 with stringent requirements for how it should be prescribed: only up to seven weeks’ gestation, dispensed in person with mandatory follow-up appointments, and with enhanced risk-reporting requirements for doctors. Along with misoprostol, the second drug in the regimen, it is, in effect, designed to induce the equivalent of a miscarriage at home.

After more than 20 years and scientific articles spanning 26 countries, the scientific consensus is that the “abortion pill” has a remarkable track record of safety and effectiveness that, in the media, is often compared to that of Tylenol or Viagra.

But following the fall of Roe v Wade in 2022, anti-abortion doctors initiated a lawsuit against the FDA in Amarillo, Texas, arguing that the drug’s approval should be withdrawn. The Trump-appointed judge Matthew Kacsmaryk ruled in favor of the doctors. Were his decision not appealed, it would have resulted in a de facto nationwide ban on medication abortion.

The government appealed to the fifth circuit appeals court in New Orleans, with a long history of law that deferred to expert federal agencies and the FDA. Although the fifth circuit struck down part of Kacsmaryk’s decision, which would have in effect banned the drug nationally, the appeals court ruled in favor of the doctors’ arguments against two FDA decisions in 2016 and 2021.

At both of those times, the FDA relaxed prescribing rules. The agency allowed doctors to see patients for one visit, approved the drug for up to 10 weeks’ gestation, reduced risk reporting, allowed dispensing through the mail and retail pharmacies, and even reduced the dose of mifepristone from 600 to 200mg.

It may sound like a wonky distinction – but the case is viewed with fear and trepidation by nearly the entire medical industry. And hundreds of pharmaceutical executives, doctors associations and even companies regulated by the FDA have lined up in the agency’s defense.

That’s for two reasons. First, the anti-abortion doctors don’t show a typical case of harm. They argue in briefs that a fraction of doctors might have been forced to treat women who needed follow-up care from medication abortions, even though no specific party is named.

Second, their arguments undermine the deference courts have long had for expert federal agencies, and in particular for the FDA, which is both the global gold standard for rigorous scientific review, and is directly involved in high-stakes decisions about the trade-offs of particular medicines in ways that have immediate impact on American health.

“The threat to our industry is real, the threat to patients is real, and it extends far beyond this medicine,” Dr Amanda Banks, an entrepreneur and former biotechnology executive, said in a press call. And the risk to the future of medical innovations is “not just in the US, but globally at fundamental risk”.

Most immediately, a decision that rolls back the FDA’s changes would reimpose all the prescribing restrictions once placed on mifepristone, even though they are not medically necessary. That would once again reshape abortion access in the US, including in Democratic-led states who may have thought themselves immune from such restrictions. More than half of abortions in the US are now performed with medication abortion.

Related: Have you used an abortion pill in the US? Share your experience with us

It could also dramatically alter the FDA’s authority. If the agency’s decisions can be undone by a judge or it can be sued by any group who outlines theoretical harm, it opens the doors for judges to make medical decisions and for nearly anyone opposed to a drug to sue.

“What you don’t want is for patients to have science unwound, so they end up faced – not only with fewer drugs or less innovation – but with outdated regimens and unnecessary burdens,” said Eva Temkin, an attorney who worked at the FDA for nearly a decade, and now advises pharmaceutical companies, medical device manufacturers and biotechnology companies at the law firm Paul Hastings.

Contraception, hormone blockers to treat gender dysphoria, vaccines and even some chemotherapy drugs all have detractors who could target the drugs in court, experts said. Commercial rivals may also have a new avenue to limit a drug’s availability.

A decision in favor of anti-abortion drugs would also dramatically alter the drug development landscape, which relies heavily on a stable body of law for investment. Bringing a new drug to market can cost anywhere from less than $1bn to more than $2bn, and may take 10 to 15 years.

“We have the most vibrant venture capital and investment community in the globe here, by several billions dollars – orders of magnitude as compared to any other region on the globe,” said Banks. “It’s been incredibly successful, and the reason why it’s incredibly successful is because we have a very, very data-driven FDA … That’s not the kind of judgment that can be replaced in a couple of weeks in a hearing by someone who isn’t trained.”

The FDA’s experts are not the sort of scientists who “change between administrations”, said Hincapie-Castillo.

Perhaps most alarming for the medical and pharmaceutical industries is that the FDA – whose expert, independent reviews are the envy of many countries – might be undone by what many prominent researchers consider pseudoscience.

“These decisions need to be shaped by the consensus science that we have, and not judicial decisions that are influenced by junk science,” said Ushma Upadhyay, a public health social scientist trained in demography and a professor in the department of obstetrics and gynecology at the University of California, San Francisco. Her work with a pharmacist helped lead to the retraction of two papers cited by the district court in Texas.

If the case goes against the FDA, said Hincapie-Castillo, “I’m very concerned with medications – what it’s going to look like going forward. These special interest groups have shown us their true colors, and they want to diminish the authority of government.”