The legal conflict over the Food and Drug Administration’s lax regulation of abortion drugs is getting more complicated by the day as a lawsuit winds its way through the federal courts. Did the FDA skip critical steps to quickly approve the drugs, and did it illegally loosen important safety restrictions later on? Let’s sort it out.
The Timeline
New drugs must be FDA-approved to go on the market. A manufacturer must provide substantial evidence that a drug is “safe and effective” for an intended use under particular conditions. In September 2000, the FDA approved Mifeprex, the brand name of the abortion drug mifepristone, for use during the first seven weeks of pregnancy.
Mifeprex did not go through the FDA’s normal evaluation process. Instead, designating pregnancy a “life-threatening illness,” the FDA used a fast-track process intended for drugs to treat illnesses such as HIV or cancer.
That accelerated approval, however, came with significant safety restrictions: dispensing could only be done by licensed physicians; three in-person physician visits were required (to administer Mifeprex, to administer a second abortion drug, and to assess any complications and ensure that the abortion was complete); and physicians had to report all medical complications.
FDA regulations allow any “interested person” to petition the FDA to “issue, amend, or revoke a regulation or order.” In 2002, two medical groups filed such a petition, challenging the FDA’s approval of Mifeprex. While those same regulations require the FDA to respond to citizen petitions within 180 days, the agency ignored the petition for more than 14 years, finally rejecting it in March 2016.
The FDA also dropped most of the original safety measures, extending Mifeprex’s use to 10 weeks, requiring only one in-person visit, allowing health care workers other than doctors to administer it, and no longer requiring doctors to report nonfatal complications.
Medical groups filed another petition in March 2019 to challenge these changes. Once again, the FDA ignored the law and, this time, waited for 994 days before rejecting the petition.
Finally, in April 2021, the FDA announced it would allow “dispensing mifepristone through the mail … or through a mail-order pharmacy.”
The Lawsuit
Last November, four medical associations and four emergency room doctors sued the FDA, alleging that its approval of Mifeprex and subsequent decisions weakening its safety restrictions were “arbitrary and capricious” under the Administrative Procedure Act. They claimed, for example, that the FDA approved Mifeprex for all women without any evidence of its impact on minors.
While the fast-track process required evidence that Mifeprex has “meaningful therapeutic benefits to patients over existing treatments,” the risk of complications such as severe bleeding is several times higher than surgical abortion.
The lawsuit was filed in the U.S. District Court for the Northern District of Texas before Judge Matthew Kacsmaryk. First, the plaintiffs asked that the FDA’s 2000 approval of Mifeprex, as well as its 2016 and 2021 safety changes, be put on hold while their legality was being litigated.
Kacsmaryk first addressed procedural issues, such as whether the plaintiffs had legal “standing,” that is, whether they were the right parties to raise these issues in court; whether they had filed the lawsuit within the statutory time limit; and whether they should first have sought a resolution from the FDA itself.
On April 7, Kacsmaryk answered yes to each of these procedural questions before issuing a stay to temporarily halt the FDA’s original approval of Mifeprex in 2000, as well as its 2016 and 2021 changes to the safety rules. He put his own decision on hold for seven days so that the FDA could appeal his stay.
The FDA did appeal, and six days later, in a per curiam, or unsigned, opinion, a three-judge panel of the U.S. Court of Appeals for the 5th Circuit agreed with Kacsmaryk that the plaintiffs had legal standing to bring the lawsuit.
In general, a plaintiff has to prove a concrete legal injury that is “actual or imminent” and that a court can address. Here, the court focused on how the FDA’s weakening of Mifeprex’s safety restrictions, especially to allow dispensing the drug by non-doctors who could not treat the resulting complications, increased the burdens on emergency room physicians.
In other words, “Hundreds of thousands of women will … need emergency care on account of [the FDA’s] actions. And because [the FDA] chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences,” the panel wrote.
The 5th Circuit next addressed whether the plaintiffs filed the lawsuit within the six-year statute of limitations for challenging a “final agency action.”
The answer was yes regarding the 2021 and 2016 safety rule changes, but the court disagreed with Kacsmaryk that the challenge to the original 2000 approval was timely. The plaintiffs argued that the FDA had “reopened” that approval decision by significantly changing the safety restrictions in both 2016 and 2021, thus resetting the six-year clock.
Acknowledging that this was a “close call” and that “plaintiffs could very well prevail” on this issue, the court decided not to block the original 2000 FDA approval of the drug while the challenge to its legality continues.
Finally, the 5th Circuit considered whether the plaintiffs had first exhausted any opportunity to address these issues with the FDA itself. The courts allow an exception to this requirement when such an administrative step would be futile.
This is where the FDA’s failure to follow the law—dragging its feet for 14 years after the petition regarding the 2000 approval and for nearly three years after the petition regarding the 2016 safety rule changes—came back to bite it. By “plainly and repeatedly refus[ing] to follow its own regulations,” the court said, the FDA showed that such attempts were indeed futile.
Having agreed with Kacsmaryk on nearly all of the procedural issues, the 5th Circuit turned to whether Kacsmaryk’s stay of the 2016 and 2021 safety rule changes should be continued. The court found two factors to be especially important.
The first is that the underlying lawsuit would likely conclude that the 2016 and 2021 safety rule changes were considered “arbitrary and capricious.” The FDA, for example, eliminated “safeguards based on studies that included those very safeguards.” Even worse, after “eliminating [the] adverse-event reporting requirement [in 2016], FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”
The second factor is whether the FDA would suffer “irreparable harm” if Kacsmaryk’s stay was not lifted. The FDA, it turns out, did not offer any evidence on this point at all.
Finally, the 5th Circuit addressed the impact of the Comstock Act, a federal law prohibiting using the U.S. mail to send or receive any “article or thing” that can be used to produce abortion. This law is especially relevant because, in its 2021 safety rule changes, the FDA began allowing the dispensing of mifepristone through the mail.
Relying on an opinion by the Justice Department’s Office of Legal Counsel, the FDA argued that the Comstock Act applied only when the sender intends the recipient to obtain an illegal abortion. As the 5th Circuit observed, however, the statute’s “plain text does not require that a user of the mails … intend that an abortion actually occur” at all, let alone that that abortion be illegal.
My colleague Sarah Parshall Perry and I have explained how the FDA’s version of the Comstock Act does not actually exist, that Congress meant exactly what it said in the statute, and that the act prohibits using the mail to send or receive abortion drugs.
The Result
The result of the 5th Circuit’s decision is that, while the lawsuit proceeds, the FDA’s original approval of mifepristone remains and the safety restrictions that were repealed in 2016 and 2021 are reinstated.
In other words, mifepristone can be used up to seven, not 10, weeks; using mifepristone will require three physician office visits; only doctors may dispense or administer the drug; doctors must report all medical complications to the FDA; and abortion drugs may not be dispensed through the mail or mail-order pharmacies.
The caveat “while the lawsuit proceeds” is very important. There may be similar lawsuits in other federal courts, and those judges may decide the procedural and substantive issues differently. But for now, the 5th Circuit has cleared the way for decisions on the merits of all these issues by Kacsmaryk, the 5th Circuit, and perhaps the Supreme Court.
This lawsuit is shining a light on whether the FDA followed the law when it approved mifepristone and when it eliminated nearly all safeguards on its use.
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