After a four-hour hearing held March 15, 2023 on a preliminary injunction motion, which, as we previously posted, seeks to overturn the Food and Drug Administration's ("FDA") long-standing approval of the drug mifepristone for use in the termination of early pregnancies in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, Judge Matthew Kacsmaryk stated he would issue an order and an opinion "as soon as possible" but did not give a precise timeline for a ruling. The Plaintiffs' motion broadly requests that the court withdraw or suspend the approvals of "chemical abortion drugs" including misoprostol, the second component of the regimen approved by the FDA for terminating a pregnancy through medication. Misoprostol, however, is also approved for the treatment of gastric ulcers, and Plaintiffs did not provide any arguments in their motion to support the withdrawal of this drug.
Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge's questions, as reported by the press, revealed to some degree his concerns about the case and the scope of the relief being requested. For example, according to news reports, the judge asked lawyers for the Plaintiffs to point to any precedent where a court issued an injunction immediately revoking or suspending the marketing of a drug long after it had been approved by the FDA. Plaintiffs' counsel conceded that they could not cite to a similar case, but pointed out other instances when the FDA took action with respect to an approval following a court decision.
The judge also asked the Plaintiffs several "procedural" questions related to standing and the six-year statute of limitations on claims against the government, referring to the limitations issue as a "nightmarish law school question on tolling." The Department of Justice, representing the FDA and the other defendants ("the government"), has argued in its opposition brief that the Plaintiffs do not have standing to sue because their allegations of injury-i.e., that the four doctors who are Plaintiffs would be harmed if they were required to treat a patient who experienced adverse events from mifepristone prescribed by another physician-are speculative. The government has also argued that most of the Plaintiffs' claims are barred by the six-year statute of limitations or have not yet been exhausted and that the only claims that could possibly be actionable relate to the narrow issues defined by the FDA's 2021 denial of the Plaintiffs' 2019 citizen petition, which relate to the gestational limit for use of the drug and requirements surrounding the administration of the drug under the supervision of a physician, not the actual approval of the mifepristone.
Despite the six-year statute of limitations, the judge questioned the government and the manufacturer of Mifeprex (the brand name for the mifepristone drug at issue in the case) about the drug's approval in 2000. One line of questioning pertained to the conditions of use the FDA permitted in the approved labeling, which were not as limited as the conditions under which the drug was studied in the clinical trials that supported the approval of the Mifeprex. This issue was raised in Plaintiffs' supporting brief in which they argued that the FDA's approval of the drug violated the Federal Food, Drug, and Cosmetic Act ("FDCA") because the "clinical trial on which the FDA relied failed to evaluate the conditions of use under the approved label." For example, Plaintiffs argued that the clinical trial protocol required each subject to first receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy and that the subject be monitored for four hours after taking misoprostol (the second drug in the two-drug regimen approved by the FDA), but these conditions were not required in the FDA-approved labeling. The government, in its opposition brief, countered that many clinical trial designs are more restrictive than will be necessary or recommended in post-approval clinical use and that the FDCA does not require that the conditions of use in a drug's approved labeling duplicate the protocol requirements used in the pre-approval studies.
Another line of questioning pertained to the FDA's approval of the drug pursuant to the agency's "Subpart H" regulations, which authorized the FDA to impose conditions to assure safe use of drugs to treat serious or life-threatening "illnesses." Plaintiffs had argued in their supporting brief that the FDA's approval of Mifeprex under these regulations was improper because pregnancy is not an illness. The government explained in its opposition brief that the FDA has consistently construed Subpart H to be available for drugs to treat serious or life-threatening conditions as well as illnesses and that pregnancy can, in fact, be a serious or life-threatening condition.
The government's opposition brief further explained that Congress subsequently enacted the Food and Drug Administration Amendments Act of 2007 ("FDAAA"), which gave the FDA authority to require a risk evaluation and mitigation strategy ("REMS") when necessary to ensure that the benefits of a drug outweigh its risks. When it enacted FDAAA, Congress deemed drugs with existing Subpart H restrictions to have a REMS in effect, and it did so with knowledge that mifepristone had been approved with restrictions pursuant to Subpart H.
Despite this discussion in the government's filing, Judge Kacsmaryk expressed concerns during the hearing that mifepristone was approved under Subpart H when other drugs approved with restrictions through these regulations were for the treatment of HIV and cancer.
The judge also entertained an argument put forward in an amicus brief filed by a group of conservative states in support of the Plaintiffs' motion that the FDA's actions to remove the in-person dispensing restrictions infringed on their state laws concerning abortion, particularly in light of last summer's Supreme Court decision in Dobbs v. Jackson Women's Health Organization, 142 S. Ct. 2228 (2022).
Judge Kacsmaryk is a Texas federal judge appointed by former President Donald Trump, and some legal experts have noted that his ideological beliefs and past decisions indicate the potential that he could rule in favor of the Plaintiffs. According to various news outlets, the judge's remarks during the hearing also suggest that he was interested in granting some of the relief requested by the Plaintiffs. Until the written order is released, however, the drug's approval status hangs in the balance. The government will likely request that any ruling that would affect the drug's approval be stayed pending appeal. An appeal of the ruling would first be heard by a panel of three judges of the Fifth Circuit Court of Appeals. The panel's decision could then be appealed either to the full Fifth Circuit or to the U.S. Supreme Court.
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