WASHINGTON — The Supreme Court on Tuesday will hear opening arguments in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze new drug development.
Industry players were initially reluctant to weigh in on the fate of mifepristone, approved by the Food and Drug Administration in 2000 for abortion up to seven weeks of pregnancy. The agency in 2016 extended that approval to 10 weeks and in 2021 removed the in-person dispensing requirement, citing years of data showing the drug’s relative safety. Now, in the wake of Roe v. Wade’s upheaval, both those later changes could be reversed after a Fifth Circuit Court of Appeals’ ruling.
“This is a dagger at the heart of the entire industry,” said Ovid Therapeutics CEO Jeremy Levin, one of hundreds of pharmaceutical executives who have since signed onto amicus briefs and open letters opposing the Fifth Circuit decision. “I would venture to guess that if [the ruling stood], the industry will be thrown into complete disarray.”
The case has obvious ramifications for reproductive rights across the country, as 21 states have instituted some form of abortion ban, leading to spikes in out-of-state travel and, advocates say, dependence on telemedicine and mifepristone prescriptions for the procedure. Over three decades, at least 60% of Americans believe abortion should be legal in the first trimester, when the vast majority do take place. Mifepristone has long accounted for roughly half of abortions, but use surged from 53% of all abortions in 2020 to 63% last year, according to reproductive rights group the Guttmacher Institute.
But pharmaceutical companies and former health officials have also mounted the argument that reversing FDA’s decisions would upend and politicize otherwise routine regulatory review processes. And it could not come at a worse time for public trust in medicine.
“Today we can say that the FDA is viewed as setting the gold standard, not just here in the U.S., but for the entire world, because we have never let politics trump good science,” Marsha Henderson, a former associate commissioner for women’s health at the agency, told reporters last week.
Henderson and others pointed to controversies over the FDA’s authorization of Covid-19 vaccines and ongoing legal battles around hormone therapies, puberty blockers, and other forms of gender-affirming care.
“If the Fifth Circuit’s ruling stands, it really gives advocates the green light to file litigation second-guessing any of the FDA’s expertise in approving drugs,” said Amanda Allen, a deputy executive director at The Lawyering Project.
While the court is not expected to make a decision on the case until this summer, Tuesday’s opening arguments could shed light on how each of the nine justices are thinking about the FDA’s decision-making.
“This is an abortion case but at root it’s an FDA case,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania who signed onto amicus brief of drug law scholars. “I’m hopeful the Supreme Court will recognize the business implications.”
PhRMA joins the fight
The major drug lobbies, PhRMA and BIO, did not file briefs when the Alliance for Hippocratic Medicine, a Christian-based medical organization, took brand-name mifepristone maker Danco Laboratories to court in Texas. Judge Matthew Kacsmaryk ultimately ruled that the FDA erred in approving the drug in the first place, imperiling its place on the market entirely.
The Fifth Circuit Court of Appeals struck that down but maintained that the FDA acted capriciously when loosening restrictions around the medicine in 2016 and 2021. Those questions, before the Supreme Court on Tuesday, are just as dangerous to the review process, industry groups argue.
The decision as it stands “threatens limitless litigation by inviting virtually any healthcare provider to bring suit to challenge any drug approval or subsequent change,” PhRMA, said in an amicus brief filed this January.
Hundreds of pharmaceutical executives and investors, including BIO, have also filed briefs and co-signed public letters warning that “the [lower court decision] has alarmed the entire pharmaceutical industry—and with good reason.”
Pfizer and BioNTech, makers of one of the two mass-distributed mRNA Covid-19 vaccines, signed onto the industry executives amicus brief. Dozens of companies working on cancer treatments, gene editing therapies, and regenerative medicines also joined.
Yet plaintiffs and their supporters argue that the FDA acted politically when making these decisions. They cite its interactions with Danco and the safety data the drugmaker provided, which contributed to the FDA’s decisions to remove certain requirements.
Levin, the Ovid CEO, drew comparisons to other agency review processes, such as interacting with developers of novel cancer therapies to determine what clinical trial data would be sufficient for approval.
“We go to the FDA, we get a scientific opinion from them as to what they think about our endpoints for a clinical trial. … Without that that type of interaction, we are forced to consider the possibility that now I would have to build an entirely parallel system in which, as I thought about developing a drug, I would have to think about how I would defend it in court,” Levin said.
The case anti-abortion advocates have to make
Besides showing that the FDA acted politically, plaintiffs have to show that the agency’s decisions actually harmed their clients and could harm them again, because they would be forced to practice medicine that violates their beliefs and exposed them to liability.
The merit of the Hippocratic Alliance’s arguments here have come up in prior hearings — namely, that it is not clear that the physicians who joined this suit have been in this scenario or could be in the future.
Drugmakers have joined in on this argument as well. In PhRMA’s brief, the lobby tries to lay out the circumstances in which that would happen: “some unspecified, non-plaintiff healthcare provider” writes the mifepristone prescription, but, if a patient experiences complications, isn’t available to treat them. That patient then ends up with a physician who has to divert time from others in their care, and expose themselves to liabilities from the procedure.
“These alleged harms describe the work that all physicians routinely perform during their daily treatment of patients,” PhRMA said in its brief.
If the court finds that the plaintiffs do not have standing, however, it does not mean the threat to mifepristone access disappears. Other providers and states, such as Missouri, have sought to join the case and could restart the process in a different district court.
What would happen first
If the Supreme Court upholds the Fifth Circuit’s injunction reversing FDA’s 2016 and 2021 decisions, mifepristone will still be on the market, but may not be available — even in its pre-2016 form — right away.
The agency and Danco, Mifeprex’s maker, would have to adjust the drug’s label, which could take several months, said Adam Unikowsky, a partner at Jenner & Block. “Mifepristone … would be immediately deemed misbranded.”
Pharmacy chains CVS and Walgreens, which just began dispensing the pill weeks ago, would have to pull it off the shelves, even in abortion-permissive states.
Reproductive-related telehealth would also be thrown into disarray, said Julie Kay, executive director of the Abortion Coalition for Telemedicine.
“We’ve seen telemedicine abortion skyrocketing both in abortion-friendly as well as abortion-hostile states,” Kay told reporters this week. “Through telemedicine abortion we’re able to serve thousands of women in banned and restricted states.”
However, there would still be a route for the drug to come back in its current form, legal experts said.
The Fifth Circuit ruled that the FDA did not provide enough explanation or evidence for making those 2016 and 2021 decisions. If the agency went back and made those decisions again — and provided, presumably, more research and justification — it could reverse restrictions once more. And, likely, end up back at court.
Olivia Goldhill contributed reporting.
This story is part of ongoing coverage of reproductive health care supported by a grant from the Commonwealth Fund.