January 11, 2024 Liz Borkowski, MPH 0Comment

The Supreme Court has agreed to hear the Alliance for Hippocratic Medicine case involving medication abortion. This case has the potential not only to further restrict access to abortion but to decide that judges, rather than FDA experts, can be the final arbiters of whether or not all of us can access the drugs we need.

At issue here is the abortion drug mifepristone, which, taken with misoprostol, is a conclusively safe and effective way to terminate a pregnancy. FDA approved mifepristone in 2000, and it now accounts for roughly half of US abortions. When it first approved the drug, FDA imposed several restrictions on how it could be dispensed. As additional data about its safety and efficacy have accumulated, the agency has lifted some, but not all, of those restrictions. In 2016, it approved a new drug label that allowed for use of mifepristone through 10 weeks up pregnancy (up from the 7 weeks for which it was first approved) and removed requirements that patients return to their providers to receive the second dose of medication necessary to complete the abortion. In 2021, FDA announced that it would not enforce the requirement that the drug be dispensed in person during the public health emergency, opening the door to prescription of mifepristone via telehealth and mail-order delivery of the drug; in 2023, it made those changes permanent.

How this got to the Supreme Court

The AHM plaintiffs originally filed their case against FDA in the U.S. District Court for the Northern District of Texas. They argued that FDA should not have approved mifepristone at all, nor should it have made the changes that expanded access. Judge Matthew Kacsmaryk granted the plaintiffs’ wishes in a decision that made unsupported assertions, ignored the weight of the evidence, and pushed an “offensively nonsensical” theory for why an organization that has not actually been harmed by the use of mifepristone should be able to bring this case in the first place.

The Supreme Court issued an order staying Kacsmaryk’s order until all appeals could be addressed. The Fifth Circuit Court of Appeals decided that FDA’s 2000 approval of mifepristone should stand but affirmed Kacsmaryk’s stays of the 2016 and 2021 FDA actions that increased access to mifepristone (though, because of the Supreme Court’s order, the Fifth Circuit’s order has not taken effect either). The Supreme Court decided in mid-December to hear an appeal from FDA and mifepristone manufacturer Danco. It will only consider FDA’s 2016 and 2021 actions, not its initial approval of mifepristone. This move “prevents the worst catastrophe,” University of Pittsburgh law professor Greer Donley told Bloomberg Law, but overturning the agency’s 2016 and 2021 actions “would still be catastrophic.”

Consequences of an adverse decision

Overturning the 2016 and 2021 changes would decrease access and compound the problems created by state abortion bans following last year’s Dobbs decision overturning the federal right to abortion. It’s horrifying that a supposedly advanced country would force people to continue unwanted pregnancies, especially given shameful maternal death rates that are particularly high for Black and American Indian/Alaska Native women. The impacts of Dobbs and the related bans would be even worse without mifepristone. People who can’t get abortions in the states where they live often travel to or seek telehealth care from providers in states where this form of healthcare remains available. The flexibility of prescribing medication remotely and allowing patients to receive it in the mail has been crucial for allowing providers in states where abortion remains legal to serve pregnant people from across the country. Closing off this avenue would put abortion further out of reach for those with the fewest advantages, who are already most harmed by abortion bans.

If the Supreme Court decides to overturn any FDA decision on mifepristone, the harm won’t just be to reproductive autonomy. Congress gave FDA the responsibility of overseeing drug approvals and restrictions, and it makes sense for an agency staffed by thousands of people with relevant expertise to decide what drugs should be available to the US public and under what conditions. It does not make sense for judges to decide what drugs we can take and how we can take them.

Courts can step in (and have done so) when FDA fails to follow the procedures Congress sets out for it, but in this case the AHM’s argument is so shoddy that any decision in its favor would be seen as politically motivated. Most notably, the doctors bringing the case claim they have standing — which requires demonstrating they’ve been harmed — because they might one day see a patient who suffered harm from taking mifepristone (even though serious complications are, as extensive evidence has demonstrated, extremely rare). As Vox’s Ian Milhiser points out, “the judges who have second-guessed [FDA’s] decisions have done so based on uninformed speculation about what else the FDA could have done to ensure that the drug is safe.”

A ruling against FDA’s changes to mifepristone’s label and restrictions will result in harm for people using a wide range of other drugs. If the Supreme Court decides it can overturn FDA actions based on flimsy rationales, we can expect to see challenges to drugs used for gender-affirming care and contraception. The entire pharmaceutical pipeline will suffer, too: If drug companies think FDA decisions about their products can be overturned by a judge who doesn’t like how people are those medications, they warned that they’ll likely stop going through the long, expensive process of getting drugs approved.

I hope the Supreme Court majority will see that authority over evidence-based drug approvals and restrictions needs to remain with FDA. If not, we can all expect to suffer.

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