In a 67-page opinion in Alliance for Hippocratic Medicine v. FDA, a federal judge on Friday “stayed” the FDA’s Sept. 28, 2000, approval of the abortion pill and the agency’s follow-up decisions from 2016, 2019, and 2021.
The detailed opinion by Judge Matthew Kacsmaryk, a Trump appointee, addresses an array of complex legal issues. Here’s what you need to know to understand the litigation.
Facts First
In 1996, the Population Council filed an application with the FDA seeking approval of the abortion pill, which is really two pills: mifepristone, also known as RU-486, and misoprostol. Mifepristone blocks the production of progesterone causing the death of the unborn human, who is nurtured by progesterone in utero. Misoprostol then induces “cramping and contractions to expel the unborn human from the mother’s womb.”
The FDA told the Population Council in February of 2000 that it did not believe the evidence submitted adequately demonstrated that the drug, if distributed as proposed, was safe and effective for use. Accordingly, the FDA concluded, the “restrictions on distribution will need to be amended.” Yet a few months later, the FDA approved the abortion drug under its Subpart H “accelerated approval” process.
The FDA’s approval was for use of the drug up to seven-weeks gestation and required three in-person office visits, first to administer mifepristone, second to administer misoprostol, and third to assess any complications and ensure the abortion had been complete. Additionally, prescribers were required to be properly trained and to report any adverse events.
In 2002, the plaintiffs filed a “citizen petition” with the FDA, objecting to the agency’s approval of the abortion drug. It was not until nearly 14 years later, however, on March 29, 2016, that the FDA rejected the plaintiffs’ 2002 petition. The same day the FDA rejected the petition challenging the initial approval of the abortion drug, the FDA removed several of the restrictions on its distribution.
Specifically, in 2016, the FDA increased the maximum gestational age from seven weeks to 10 weeks. The FDA also reduced the number of office visits from three to one, allowed non-doctors to prescribe and administer the drug, changed the dosage, and eliminated the requirement that adverse events be reported, unless they proved fatal.
Plaintiffs filed a second citizen petition with the FDA in 2019, challenging the FDA’s 2016 removal of the various safety restrictions. On Dec. 16, 2021, the FDA denied the 2019 petition. In the interim, in 2019, the FDA approved the distribution of a generic version of the abortion pill. On April 12, 2021, the FDA announced it would allow mifepristone to be dispensed through the mail, ostensibly due to Covid, but the FDA has since made mail distribution a permanent option.
In November of 2022, the plaintiffs, who consist of doctors and national medical associations that provide health care for pregnant and post-abortive women and girls, sued the FDA, challenging the initial 2000 approval of the abortion drug, the removal of the safety precautions in 2016, the approval of the generic chemical-abortion drugs in 2019, and the 2021 decision to permit the distribution of the drug via the mail. Soon after, the plaintiffs filed a motion for a preliminary injunction, seeking a court order directing the defendants to withdraw or suspend the various FDA decisions.
Do the Plaintiffs Have Standing?
Before addressing the merits of the case, the court analyzed the initial question of “standing,” or whether the plaintiffs have the right to sue. To have standing, plaintiffs must generally show they suffered a concrete injury, caused by the defendant, that can be “redressed” by the court.
The court held the plaintiffs had standing to sue as an association whose members had standing. Those members, who are doctors, have standing, the court held, because they alleged that the approval of the dangerous abortion drugs injures them by overwhelming the medical system and placing “enormous pressure and stress” on the doctors during emergencies and complications.
Friday’s opinion further concluded the medical association members had standing to challenge the FDA’s decision on behalf of their patients. Here, the court noted the Supreme Court has allowed abortion doctors to represent the interests of women seeking abortions, notwithstanding the conflict of interest between the two — with the abortionists often seeking to scrap laws designed to protect their patients. In this case, the court reasoned, the doctors’ relationship with patients is at least as close, if not closer, further justifying standing.
A third basis for standing exists, the court added, based on the harm to the association itself because the FDA’s approval of the abortion drug forces the plaintiffs to redirect their resources from other activities to educate the public on the dangers of the abortion pill.
Did the Plaintiffs Wait Too Long to Sue?
A second preliminary question the court addressed concerns the timeliness of the lawsuit. The FDA argued the plaintiffs’ challenge to the 2000 approval of the abortion pill was time-barred because it had rejected the citizen petition in 2016 and the statute of limitations is six years. The court rejected that argument, holding that by undertaking a full review of the safety provisions in 2019, the FDA had restarted the limitation period.
Alternatively, the court concluded the plaintiffs’ challenge to the 2000 approval is not time-barred based on the principle of equitable tolling. “It took FDA 13 years, 7 months, and 9 days to respond to the 2002 Petition,” the court stressed. Then in responding, the FDA “moved the goalposts by substantially changing the regulatory scheme on the same day it issued its Response.”
Another delay soon followed, with the FDA taking almost three years to respond to the 2019 petition. “Thus, in the 20 years between the 2002 Petition and the filing of this suit, Plaintiffs were waiting on FDA for over 16 of those years,” the court noted, saying fairness favored the plaintiffs under these circumstances.
Must the Plaintiffs Wait Years More Before Suing?
The Biden administration presented one more preliminary challenge to the lawsuit, arguing the plaintiffs could not challenge the FDA’s 2019 approval of a generic version of the abortion drug or the FDA’s 2021 decision to allow the distribution of the drugs via the mail because they did not “exhaust” their administrative remedies, meaning they did not present these complaints to the FDA first.
The court rejected this argument as well, finding exhaustion was not required for a variety of reasons — explained in detail in the opinion — including that seeking review by the FDA would be “futile.”
“Any attempt by Plaintiffs to challenge Defendants’ actions would likely be futile,” the court reasoned, because “even if Plaintiffs did not endure sixteen years of delay, dawdle, and dithering, their efforts would surely ‘be futile because the administrative agency will clearly reject the claim.’” Here, the court pointed to President Biden’s emphasis post-Dobbs on “the need to protect access to mifepristone.”
Next, the Merits
Of the legal challenges, the narrowest one concerns the FDA’s decision to allow the distribution of the abortion pill via the mail. Kacsmaryk held that that decision violates the 1873 Comstock Act, which makes it illegal to send by mail: “[e]very article or thing designed, adapted, or intended for producing abortion,” and “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.”
Notwithstanding this plain language, the Biden administration argued the Comstock Act only prohibits the mailing of abortion drugs if the sender intends them to be used “unlawfully.” But that is not what the Comstock Act says, and Kacsmaryk held that when the language of a statute is clear, the court must enforce it as written.
Could FDA Approve the Drugs under Subpart H?
As noted above, the FDA approved the abortion pill in 2000 under the auspices of its Subpart H, titled, “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.” Approval under Subpart H requires drugs to satisfy two requirements. First, drug studies must establish its “safety and effectiveness in treating serious or life-threatening illnesses.” Second, the drug must “provide [a] meaningful therapeutic benefit to patients over existing treatments.”
The court held the FDA’s approval of the abortion pill in 2000 violated Subpart H first because it did not “treat” a “serious or life-threatening illness,” and second because it did not provide a therapeutic benefit” over surgical abortions. In reaching these conclusions, the court stressed that pregnancy is not a sickness, much less a “life-threatening” one, and that the FDA lacked any evidence showing the abortion pill provided a benefit over surgical abortion.
Did FDA Act Arbitrarily and Capriciously?
The final question before the court concerned the legality of the FDA’s approval of the abortion pill and its generic offspring. By statute, the FDA must deny approval of a new drug application if the agency has insufficient information to determine if the drug is safe for use as intended.
In seeking approval of the abortion pill, the applicant, the Population Council, relied on U.S. trials that required:
(1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy; (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol.
Yet the original 2000 approval and then the later modifications lacked these basic safety precautions. These omissions, the court stressed, and especially the FDA’s failure to require an ultrasound to identify ectopic pregnancies, increased the danger of the abortion pill. The court also noted the FDA “entirely failed to consider an important aspect of the problem” by omitting any evaluation of the psychological or long-term medical consequences of the drug.
What the court found most significant, however, was the FDA’s initial conclusion that it lacked adequate information “to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.” Notwithstanding that finding, the FDA, after political pressure, altered course and approved the abortion pill.
The court concluded that, under these circumstances, the FDA had acted arbitrarily and capriciously by acquiescing “on its legitimate safety concerns — in violation of its statutory duty.” And because the generic approval relied on the flawed 2000 approval, that decision likewise was arbitrary and capricious, the court held.
The FDA has already filed a notice of appeal to the Fifth Circuit Court of Appeals. On appeal, the Biden administration will reassert these various arguments. Whether the Fifth Circuit will agree with the FDA remains to be seen. But Kacsmaryk’s thorough analysis of the record will make it difficult for the appellate court to hide behind the FDA’s discretion because his opinion exposes the lack of scientific support for the FDA’s approval of the abortion pill.
Time will tell, though — and maybe, too, the Supreme Court.
