Will the Supreme Court Close the Door on Judicial Meddling with FDA’s Scientific Determinations?
Last week’s oral arguments in the Supreme Court case about medication abortion don’t just have implications for reproductive rights — the case will also help determine whether the Food and Drug Administration (FDA) will remain in charge of scientific determinations about drug safety.
In late 2022, The Alliance for Hippocratic Medicine (AHM), a group apparently created for the express purpose of bringing this lawsuit, challenged FDA’s approval of the abortion drug mifepristone and later changes the agency made to relax some of the unnecessarily strict procedures that made it hard to access. Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas responded with a decision that sounded more like an anti-abortion advocacy brief than legal reasoning. Kacsmaryk’s decision suspending FDA’s approval of mifepristone brushed aside the mountains of scientific evidence of the drug’s safety and effectiveness and focused on outlier studies that have since been retracted.
The Biden administration appealed to the Fifth Circuit. That court ruled that too many years had elapsed since FDA’s 2000 approval of mifepristone, so they couldn’t undo that decision. They ruled instead that the drug could remain on the market but that the agency’s 2016 and 2021 changes should be revoked. (The changes in question extended the time for which the pills can be used from 49 days to 70 days of pregnancy, allowed advanced practice clinicians as well as physicians to prescribe them, and removed a requirement that patients receive the drugs in person from a healthcare provider.) This decision was less catastrophic than Kacsmaryk’s in that it would make mifepristone more difficult to access but not remove it from the market altogether, but it was just as problematic in its unprecedented assumption that courts can substitute their judgment about drug safety for that of FDA’s experts. Now the Supreme Court gets to decide.
The Supreme Court’s Possible Dodge
The Supreme Court stayed the lower courts’ decisions until it could hear the case, and after last week’s oral arguments Court watchers don’t expect that this will be the case to put mifepristone out of reach. Several justices questioned AHM’s lawyer about whether the organization even had the standing necessary to sue FDA in the first place — that is, have they suffered the kind of harm that enables them to make this kind of legal challenge?
It's a testament to the safety and efficacy of mifepristone that the powerful interests behind this case couldn’t find anyone who’d actually suffered harm to bring the challenge. Instead, AHM claims that it has standing because its doctors might one day treat a patient who is suffering complications from a medication abortion. Justice Elena Kagan noted that the standing argument was “very probabilistic,” and Justice Ketanji Brown Jackson pointed out the “significant mismatch” between this theoretical possible harm and the effects of reducing access to mifepristone. Only Justices Clarence Thomas and Samuel Alito seemed willing to accept AHM’s standing fig leaf.
Given these responses, it seems likely that the Court will decide this case by determining that AHM lacks standing. This is an appropriate conclusion to draw, and it will avoid the increase in access problems that a decision in AHM’s favor would have caused. Since the 2022 Dobbs v. Jackson Women’s Health Organization decision removed the federal right to abortion, state bans have left many abortion seekers scrambling to access care — and the problem disproportionately affects states with high proportions of Black and Latinx residents. Some people from abortion-ban states obtain abortion pills from online providers or services like Aid Access (see Plan C for resources); some travel to abortion-supporting states, where medication abortion is an essential element of caring for a growing patient population. Some people — mostly those with the fewest resources — are forced to bear children against their will. If the Supreme Court declines to exacerbate these problems, at least for the moment, that’s a relief. An even better outcome would be a clear statement from the Court that judges should not insert themselves into scientific questions about drug safety that are best answered by FDA experts.
Why FDA Should Remain in Charge of Drug Safety Determinations
FDA is not infallible. Sometimes it decides to approve a drug based on slim evidence because no other treatments are available for a serious condition, and later research indicates the drug doesn’t actually work. Sometimes a political appointee overrules a determination reached by experts. But FDA’s process is robust: When a drug company submits an application for a new drug or a label modification, career staff with relevant expertise comb through the data and often request additional information or research from the manufacturer, sometimes engaging in a multi-year back-and-forth. They often seek advice from one or more advisory committees composed of top experts from outside the agency. They accept input from the public. Even if FDA isn’t perfect, I’d far rather trust my health to its process than to the preferences of judges who are not required to have any kind of specialized medical knowledge.
Letting judges decide whether and how drugs can be marketed isn’t just bad for the patients who rely on targeted drugs; it’s also bad for public trust in our system and for pharmaceutical companies’ willingness to invest in future drug development. In an amicus brief submitted for this case, pharmaceutical manufacturers warned that if judges are able to interfere with FDA’s determinations, they’ll no longer be confident that FDA approval means years of future sales — so they won’t have the incentive to devote the substantial resources required to obtaining that approval in the first place. We could see our drug supply dwindle as ideological attacks endanger contraception, gender-affirming care, and vaccines and as unscrupulous companies target their competitors’ drugs. I hope the Supreme Court will recognize how harmful this would be to public health and rule that it is inappropriate for judges to make determinations that are best left to FDA.
About the author
Liz Borkowski is the managing director of the Jacobs Institute of Women’s Health at the Milken Institute School of Public Health at George Washington University. She is the managing editor of Women’s Health Issues, the peer-reviewed journal of the Jacobs Institute, and a member of the GW Center of Excellence in Maternal and Child Health. She has an MPH in health policy from George Washington University.
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