A Nationwide Mifepristone Ban - Alliance for Hippocratic Medicine vs. U.S. FDA
By Guest Contributor Kate Baxter-Kauf, J.D.
If you're a person interested in maintaining and expanding abortion access in Minnesota and throughout the United States, you may have read about a case in Texas involving the restriction of medication abortion and wondered, what is going on with that? It's a good question, and worth an explanation.
In November 2022, an anti-choice organization calling itself the Alliance for Hippocratic Medicine filed a lawsuit in the Northern District of Texas that argues that the FDA, which regulates drugs in the United States, did not act within its allowed authority when it approved mifepristone in 2000, the first medication taken as part of the medication abortion used to induce an abortion and when it included misoprostol in the medication abortion regimen. The case, styled Alliance for Hippocratic Medicine (AHM) v. FDA, 2:22-cv-00223-Z (W.D. Tex.), argues that because the FDA lacked authority to approve the drugs in 2000, the decision should be set aside and enjoined. The plaintiffs further argue that the FDA violated an 1873 law that prohibits the distribution of abortion-inducing drugs by mail. They argue that they are entitled to a preliminary injunction that would enjoin the FDA's approval of these drugs and basically roll back the 2000 decision that approved them for distribution in the first place while the case proceeds. If that were to happen, that would potentially limit use of these drugs in all 50 states because their use depends on FDA approval.
As you may know, medication abortion typically occurs in the United States, via use of with two different drugs—mifepristone followed by misoprostol. More than half of abortions in the United States are medication abortions, and the number is only increasing based on ease of use and privacy concerns. Medication abortions are extremely effective and extremely safe from all of the objective scientific data we know.
This case is novel. In general, it is very difficult to challenge FDA approvals and doing so 22 years after the fact is without precedent. But the case is being brought by anti-choice organizations who want to use these novel theories to argue that, contrary to scientific understanding or 22 years of approval, these drugs should be removed from the market. Almost all objective legal observers have indicated that the legal argument being made by the plaintiffs is not correct and that they do not meet the requirements for a preliminary injunction, which is an "extraordinary remedy" that requires the party seeking it to meet a high standard. The case is almost certainly time-barred, the plaintiffs have not been injured and thus cannot bring the suit, and the FDA is not really subject to oversight by courts in this way. So why do the plaintiffs think they can win? Because they filed the case in a friendly jurisdiction, the Northern District of Texas, and drew an incredibly anti-choice judge, J. Matthew J. Kacsmaryk, who indicated at a hearing on March 15, 2023 that he was open to their lawsuit and to trying to grant their request at least in part.
It will be interesting to see what happens next, but one thing is clear: this is the beginning of the fight and not the end. If Judge Kacsmaryk does what the plaintiffs request, and tries to enjoin or roll back FDA approval of mifepristone, it will tee off several larger legal battles. For one, as an amicus brief from FDA law scholars argues, Congress crafted procedures by statute for the FDA's use in withdrawing drug approval. A preliminary injunction order withdrawing FDA approval for mifepristone would presumably violate federal law. And even then, a unanimous 1985 Supreme Court decision held that the FDA is in charge of its own enforcement regime, meaning that if distributors or states refused to follow J. Kacsmaryk's order, it's not clear that the FDA can be required to enforce the ruling. The FDA could even issue guidance saying it would not prosecute or enforce the ruling, which would probably be necessary (and possibly not sufficient) for doctors and manufacturers to feel comfortable acting. This could get especially complicated given that a preliminary injunction and order in one legal case generally only applies to the parties in the case. Here, those parties would include the FDA, the plaintiffs, and Danco, the brand-name manufacturer of mifepristone, which decided to get involved in the case as a party. Based on general civil procedural rules and constitutional guarantees of due process, generally, no other party could be enjoined, including GenBioPro, the generic manufacturer of mifepristone, nor abortion providers around the country who prescribe mifepristone.
One real concern in the interim would be the chilling effect that a wide-ranging order could have on distributors, manufacturers, and providers, and that should not be underestimated. But the legal questions are complicated, in large part because J. Kacsmaryk would be defying a lot of legal precedent and norms by ruling in favor of the Plaintiffs. It's worthwhile to keep watching; an order is expected following the March 15, 2023, hearing, and federal judges have no deadlines on when they can act, so a ruling could come at any time.