DRUGS USED

In 2000, the Food and Drug Administration (FDA) approved mifepristone as part of a two-drug protocol used to terminate pregnancies. This regimen accounts for over half the abortions in the United States,1 and mifepristone is generally viewed by the medical community as safe and effective.2 Less than a year after the Supreme Court overturned Roe v. Wade, abortion opponents lodged a challenge to the FDA’s approval and regulation of mifepristone. Although in its beginning stages, this litigation may ultimately result in further limits on abortion access, even in states where it remains legal.

When the FDA approved mifepristone over twenty years ago, it did so under what are known as Subpart H regulations, which “accelerate[] approval of drugs ‘that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments . . . .’”3 As a part of this process, the FDA required certain post-approval safety measures for mifepristone’s use, including limiting the drug for use through 49 days gestation; requiring three in-person office visits; requiring the supervision of a qualified physician; and requiring the reporting of all adverse events.4

Since that time, the FDA has made several changes to mifepristone’s conditions of use. In 2016, the agency increased the maximum gestational age for use from 49 to 70 days; reduced the number of required inperson office visits from three to one; allowed non-doctors to prescribe and administer the drug; and eliminated the reporting requirement.5 And with the onset of the COVID-19 pandemic, the FDA approved mail delivery for mifepristone, a modification that has since become permanent.6

In November 2022, a group of anti-abortion physicians and medical associations filed suit in federal district court in Amarillo, Texas, challenging the FDA’s original approval of mifepristone, as well as its subsequent changes to the drug’s conditions of use.7 As a general matter, plaintiffs sought a preliminary injunction ordering the FDA to withdraw or suspend its 2000 approval of mifepristone, which would remove it from the list of Approved Drugs.8

The only district court judge in Amarillo is Matthew Kacsmaryk, a Trump appointee who has become well known for ruling in favor of conservative litigants, including in reproductive-rights cases.9 Critics assert that conservative groups have engaged in improper forum shopping in order to have their causes heard by judges, such as Kacsmaryk, to whom the mifepristone litigation was predictably assigned.10

On April 7, 2023, Judge Kacsmaryk issued a 67-page opinion granting plaintiffs’ requested preliminary injunction, ruling that they were likely to succeed on their claim that mifepristone’s approval resulted in an unsafe drug’s entry onto the market.11 In particular, he concluded that the FDA’s approval violated the Subpart H regulations because (1) pregnancy is not a “serious or life-threatening illness” as contemplated by the regulations, but rather “a normal physiological state most women experience one or more times during their childbearing years,”12 and (2) mifepristone did not provide a “meaningful therapeutic benefit” over surgical abortion because of alleged higher rates of adverse events, such “hemorrhaging, incomplete abortion, and unplanned surgical evacuation,”13 as well as mental health issues stemming from “the mother seeing the aborted human[, which] appears to be a difficult aspect of the . . . process [that] can be distressing . . . .”14

The court also held that plaintiffs would likely succeed on their claim that the FDA’s post-2016 modifications to mifepristone’s conditions of use were contrary to law, including its elimination of the in-person dispensing requirement. The district court found this change would likely violate the Comstock Act,15 a rarely enforced statute enacted in 1873 that classifies as nonmailable every “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use it or apply it for producing abortion.”16

Emergency Appeals to the Fifth Circuit and the Supreme Court

Judge Kacsmaryk put his ruling on hold through April 14, 2023, to allow the federal government to pursue an emergency appeal,17 which it and Danco Labs, the company that distributes mifepristone, did. The Fifth Circuit granted, in part, defendants’ requested stay of the district court’s ruling pending appeal.18 The court agreed with defendants’ contention that certain of plaintiffs’ claims were likely time-barred (e.g., their challenge to the drug’s original approval).19 But because the court determined that plaintiffs were likely to succeed on the merits of their challenges to the FDA’s post-2016 actions, including allowing mailaccess to the drug, it concluded that a stay of these parts of the lower court’s ruling was not warranted.20

The next stop for defendants was obviously the Supreme Court. Justice Alito, who handles emergency requests from the Fifth Circuit, initially issued an administrative stay on Judge Kacsmaryk’s ruling on April 14, 2023, and then extended it a second time.21 On April 21, 2023, at 6:30 p.m., the Court, in an unsigned order with no substantive analysis, placed the district court’s decision on hold and sent the matter back to the Fifth Circuit.22 This means that the FDA’s current mifepristone policies will remain in effect while the case is litigated in the Fifth Circuit and, most likely, the Supreme Court itself.23

The Court’s order constitutes a very temporary victory for the Biden administration on this issue, as oral argument has already been scheduled in the Fifth Circuit for May 17, 2023. It is unlikely that the Fifth Circuit’s views will change substantially following argument,24 and thus we can expect to see another appeal to the Supreme Court. And there are many issues on which the case could turn, apart from the merits, once it reaches the Court—e.g., plaintiffs’ standing, the timeliness of their claims, and the reviewability of FDA’s drug-approval process, among others. Although the ultimate outcome remains to be seen, there is no doubt that the decision could have sweeping ramifications for “abortion access nationwide amid a legal landscape that has been upended since the Supreme Court reversed Roe.”25 https://www.latimes.com/opinion/story/2023-04-25/supreme-court-mifepristoneruling-abortion-judges

2

21, 2023 6:59 PM), https://www.npr. org/2023/04/21/1170742958/u-s-supreme-court-blocks-lower-court-decision- continued on page 26