The Supreme Court has agreed to examine the Food and Drug Administration’s decisions in 2016 and 2021 to drop virtually all safety precautions for obtaining and using abortion drugs.
The Supreme Court’s involvement in any case related to abortion provokes all sorts of hysteria. But the court’s decision here will not just be about abortion, but also will say a lot about whether powerful agencies must follow the law when making rules that can dramatically affect Americans’ lives.
Here’s a quick recap of how the FDA v. Alliance for Hippocratic Medicine case arrived at the Supreme Court.
Prescription drugs may not be marketed in the United States without the FDA’s finding that they are “safe and effective.” The FDA approved Mifeprex, the brand name of the drug mifepristone, in 2000 to cause an abortion in the first seven weeks of pregnancy when used with the drug misoprostol. Knowing it could not approve Mifeprex through its normal process, the FDA used an emergency, fast-track procedure normally reserved for drugs that treat “serious or life-threatening illnesses,” effectively equating pregnancy with cancer or HIV.
Because the FDA used that fast-track process, obtaining and using Mifeprex came with extensive safety restrictions. It had to be prescribed by a physician, dispensed, and administered in person by a certified provider, and all medical complications had to be reported to the FDA.
Federal law allows “citizen petitions” asking agencies to change or revoke such decisions and three pro-life organizations submitted one in 2002 urging the FDA to stop distributing or marketing Mifeprex and to withdraw its approval. The law requires agencies to respond to citizen petitions within 180 days; however, the FDA did not respond for 14 years, finally denying the petition in March 2016.
When it denied the citizen petition in 2016, the FDA also expanded Mifeprex’s use to the first 10 weeks of pregnancy, no longer required reporting of non-fatal complications, and allowed non-physicians to prescribe and administer the drug.
In other words, the FDA began dropping the very safety precautions that supposedly justified the original fast-track approval in the first place—even though abortifacients carry a significantly higher risk of complications than even surgical abortions do.
Even worse, the FDA did not examine whether dropping multiple safety rules at the same time would affect Mifeprex’s safety and effectiveness. Nor did the FDA have any evidence about how doing so would affect minor girls. Pro-life groups again filed a citizen petition asking the FDA to revoke its decision and, once again, the FDA ignored the petition for years before denying it in December 2021.
The FDA then—during the height of the COVID-19 pandemic and using it as an excuse—dropped the remaining safety rules, making permanent its decision allowing women to obtain Mifeprex or its generic version by mail or through mail-order pharmacies. This violated the Comstock Act, a federal law prohibiting using the mail to distribute any “article or thing designed, adapted, or intended for producing abortion.”
In yet another twist, the FDA claimed that the lack of reported medical complications showed that abortion drugs are safe—when it was the FDA itself that ended the requirement that most medical complications with use of the drug be reported. The FDA also dropped gender-specific pronouns such as “she” and “her” without any evidence about how mifepristone would affect women or girls taking puberty blockers or opposite-sex hormones.
In November 2022, four medical associations and four individual doctors filed a federal lawsuit challenging the FDA’s original 2000 approval of Mifeprex and its 2016 and 2021 decisions dropping safety precautions. They argued that each of these actions violated the Administrative Procedure Act, which prohibits agency actions that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
This litigation involves both procedural and substantive issues.
On the procedural side, the main question is whether the plaintiff organizations and doctors have standing to bring this lawsuit. As required by Article III of the Constitution, standing requires that a plaintiff be legally injured by the defendant in a way that a court can remedy. In this case, the lower courts concluded that the medical associations could sue on behalf of their members and that the doctors could sue because they would be forced to treat more women with post-pill complications as a result of fewer safety precautions.
The substantive issue is whether the FDA’s decisions to drop safety precautions were “arbitrary and capricious” under the Administrative Procedure Act. It is important to remember that this case is not about the FDA’s actual decisions, but the process it went through in making them.
Should the Supreme Court, like the lower courts, find that the FDA dropped important safety precautions without sufficient grounds or contrary to existing evidence, the FDA likely already has a plan in place for going through the process again. In other words, it is likely, even if the Supreme Court rules against the FDA and finds that its 2016 and 2021 actions were illegal, the agency will still find a way to make Mifeprex more easily accessible.
The Supreme Court did not accept the plaintiffs’ appeal regarding the FDA’s original 2000 approval of Mifeprex for use and distribution at all. The lower appeals court concluded that the lawsuit was filed too late in time to challenge that approval from 23 years ago, and the Supreme Court is letting that determination stand.
But by agreeing to address the standing and “arbitrary and capricious” issues, the court’s decision will influence whether government agencies must follow the law when making these decisions. And it will determine the ability of Americans affected by these laws to hold the authoring agencies accountable for those decisions.
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