In a highly anticipated ruling, a Texas district court ruled to stay the Food and Drug Administration's (FDA's) administrative approval of mifepristone (a medication abortion drug) and the agency's later actions regarding the drug, as challenged in the litigation. On the same day, a Washington State district court preliminarily enjoined the FDA from "altering the status quo" regarding the availability of mifepristone under a January 2023 risk evaluation and mitigation strategy (REMS). The Texas ruling in particular, if it goes into effect, will have a significant impact on employer-sponsored health plans that currently cover mifepristone for medication abortion.
Overview of FDA's Mifepristone Approval Process (2000 to Present)
Both the Texas and Washington State rulings recount the FDA's approval process for mifepristone. As background, the FDA approved mifepristone (under the brand name Mifeprex) in 2000 using a regulation that permits accelerated approval for new 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" (21 C.F.R. §§ 314.500, 314.520 (Subpart H)). Mifepristone was approved:
With an initial gestational age limit of up to seven weeks.
For use in coordination with a drug called misoprostol, which was already approved at the time.
Subject to restrictions that included an in-person dispensing requirement (initially by doctors in a hospital or similar setting).
In 2002, two of the plaintiffs in the Texas litigation asked the FDA (in a citizen petition) to withdraw its approval, but the FDA denied that petition in 2016.
Began reviewing the REMS for mifepristone to determine whether it should be changed.
In early 2023, the REMS was updated to remove the in-person dispensing requirement and impose a pharmacy certification rule. Under the latter provision, pharmacies that dispense mifepristone must be specially certified by (among other requirements) being able to ship mifepristone using a shipping service with tracking capabilities and designating an authorized representative to manage the certification on the pharmacy's behalf (including to comply with the governing mifepristone REMS program).
The plaintiff-states in the Washington State litigation challenged the FDA's January 2023 modifications to the agency's REMS for mifepristone. In particular, the states sought a preliminary injunction asking the court to:
Affirm the FDA's original approval of mifepristone and prohibit the agencies from removing the drug from the market.
Prevent the FDA from changing the status quo to make mifepristone less available in the states that joined the litigation as plaintiffs.
Prohibit restrictions on mifepristone under the January 2023 REMS which, the states asserted, violated the Administrative Procedure Act (APA).
The district court concluded that the states established standing by alleging direct harm related to the 2023 REMS (for example, the cost to state Medicaid and related programs from increased surgical abortions and pregnancy care).
In their claim under the APA, the plaintiff-states argued that mifepristone no longer required a REMS program with elements necessary to assure safe use (ETASU). For example, the states asserted that:
Serious adverse events related to mifepristone are very rare.
Mifepristone has an extremely low fatality rate and is safer than most drugs for which the FDA has never sought to impose a REMS.
There are no logical scientific grounds for imposing additional burdens on mifepristone that are not applied to riskier drugs.
The court concluded that the states demonstrated irreparable harm (for purposes of the preliminary injunction standard) in that the REMS program for mifepristone resulted in economic costs. In particular, the court accepted the states' argument that restricted access to mifepristone caused individuals to "miss the window for medication abortion," meaning that their only remaining options are surgical abortion or carrying a pregnancy to term—both of which impose greater costs on state-operated health care programs.
The court concluded that the remaining preliminary injunction factors (balance of equities and public interest) also favored a preliminary injunction.
Remedy for APA Violation
As a remedy, the court preliminary prohibited the FDA from altering the status or rights of the parties under the operative Mifepristone REMS Program until a determination on the merits is made. However, the court declined to apply this remedy nationwide; the preliminary injunction applies only to the plaintiff-states (Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Pennsylvania, Rhode Island, Oregon, Vermont, Washington) and the District of Columbia.
In the Texas litigation, the district court issued an order that (subject to a seven-day stay):
Suspends the FDA's approval of mifepristone.
Essentially prohibits mifepristone from being made available in interstate commerce.
Doctors and Medical Associations Had Standing to Sue
On a threshold issue, the court concluded that the plaintiffs (doctors and associations representing doctors) had standing to sue. The court reasoned that the medical associations had associational standing related to strain on the medical system from medication abortions, including pressure on doctors from related emergencies (for example, blood transfusions). The court also accepted the doctors' standing argument that the lack of information on adverse events related to medication abortion damaged the doctor-patient relationship in that women are prevented from giving informed consent to their doctors.
The court further reasoned that the plaintiffs had associational standing from their members' (doctors') third-party standing to sue on behalf of their patients (who, according to the doctors, have sustained intense side effects and significant complications from medication abortions). The court also determined that the medical associations had organizational standing to sue. The court accepted the argument that the FDA's failure to require reporting of adverse events linked to medication abortion forced the associations to allocate resources to educating member doctors and the general public about the danger of medication abortion drugs.
Doctors' and Medical Associations' Claims Were Not Time-Barred
The court rejected the FDA's argument that most of the doctors' challenges to the agency's actions from earlier in the 2000s were time-barred under the applicable six-year statute of limitation. Applying a "reopening doctrine," the court concluded that the doctors' challenges (which would otherwise have been untimely) could proceed because the FDA's regulatory actions in 2016 and 2021 were a reexamination of its earlier administrative choices that restarted the statute of limitations. In particular, the court reasoned that the FDA's 2016 changes to regulating medication abortion (for example, extending the maximum gestational age for which the drugs could be used from seven to ten weeks), were a significant departure from the FDA's original approval of medication abortion in 2000. The court observed that the FDA repeatedly changed its original 2000 approval by removing protections and otherwise modifying the medication abortion regulatory rules (for example, by removing the in-person dispensing requirement in 2021). The court concluded that because the FDA reaffirmed its earlier actions after conducting a substantive review of those actions, the limitations period for the actions began in 2021. As a result, the doctors' claims were not time-barred.
Alternatively, the court found that the doctors' claims were not time-barred under an equitable tolling theory. The court determined that equitable tolling was appropriate due to the FDA's unreasonable delay in responding to the doctors':
2002 citizen petition challenging the FDA's 2000 approval of medication abortion in 2016 (almost 14 years after the petition was filed).
2019 citizen petition challenging the FDA's 2016 removal of certain protections (a delay of nearly three years).
These delays (among other reasons) also led the court to excuse the doctors' failure to exhaust available administrative remedies concerning their claims. Requiring exhaustion, the court reasoned, could result in "another decade-plus of waiting for [the FDA] to give [the plaintiffs] the time of day."
Preliminary Injunction Analysis: Likelihood of Success on Merits
In the core of its ruling, the Texas district court concluded that the doctors demonstrated the four requirements for receiving a preliminary injunction, namely:
A substantial likelihood of success on the merits.
A substantial threat of irreparable harm if the injunction does not issue.
A threatened injury that outweighs any harm that will result if the injunction is granted.
The grant of an injunction is in the public interest.
Much of the court's analysis addressed the "likelihood of success on the merits" requirement, regarding both the FDA's pre-2021 and 2021 actions.
Pre-2021 Regulatory Actions
The district court concluded that the challenges to the FDA's pre-2021 actions involving medication abortion (including its 2000 approval of these drugs) had a substantial likelihood of success on the merits for preliminary injunction purposes. Regarding the FDA's initial approval of medication abortion drugs in 2000, the doctors asserted that the agency improperly approved these drugs under the Subpart H regulation. As noted, Subpart H permits accelerated approval for new 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" (21 C.F.R. § 314.500 (Subpart H)). The doctors argued that medication abortion drugs:
Were not typically used to treat serious or life-threatening illnesses.
Did not offer a meaningful therapeutic benefit.
Largely accepting the doctors' arguments, the court reasoned that pregnancy is not a "serious or life-threatening illness" for Subpart H purposes. The court concluded that the Subpart H approval process was intended for use concerning conditions such as HIV, cancer, bacterial infections, and leprosy—but not pregnancy. The court also determined that medical abortion drugs do not offer a meaningful therapeutic benefit, in part because (according to studies) medication abortions are more likely to result in emergency room visits than surgical abortions. For these and other reasons, the court concluded that the doctors had a substantial likelihood of prevailing on their claim that the FDA violated Subpart H in approving medication abortion.
Separately, the court concluded that the FDA's pre-2021 actions in approving medication abortion were arbitrary and capricious. For example, the court observed, the FDA:
Largely overlooked the intense psychological trauma and post-traumatic stress to women from medication abortion.
Failed to include safeguards in approving mifepristone that were part of the clinical trials for the drug, such as requiring ultrasounds to identify ectopic pregnancies and confirm gestational age.
These (and other) failures, in the court's view, were "based on plainly unsound reasoning" and resulted in many deaths and more severe (or life-threatening) adverse reactions. The court reached similar conclusions regarding the FDA's substantial changes in 2016 to the medication abortion regimen.
2021 Regulatory Actions
The court separately addressed the FDA's 2021 regulatory actions of eliminating the in-person dispensing requirement and permitting medication abortion drugs to be dispensed by mail or mail-order pharmacy. The court concluded that the doctors had a substantial likelihood of success on their claim that allowing medication abortion drugs to be dispensed through mail violated federal criminal law. This claim involved a prohibition under the Comstock Act (initially enacted in 1873) on mailing items that can be used or applied for producing abortions (18 U.S.C. § 1461).
The FDA asserted that, under a consensus view adopted by the federal courts, the Comstock Act did not prohibit items to produce abortion from being mailed if the sender does not intend those items to be used unlawfully. (In an Office of Legal Counsel memorandum from late 2022, the Biden administration also concluded that the Comstock Act does not prohibit the mailing of mifepristone or misoprostol if the sender lacks the intent that a recipient of the drugs will use them unlawfully (Office of Legal Counsel (Dec. 23, 2022); see also Legal Update, White House Addresses Post-Dobbs Access to Medication Abortion (Mifepristone).))
Rejecting the FDA's argument, the court concluded that:
The Comstock Act's plain text controlled over legislative history that might suggest a different interpretation.
The Act was not implicitly repealed by later laws addressing the regulation of drugs (for example, the Food and Drug Administration Amendments of 2007 (FDAAA)).
Stay of FDA Approval of Mifepristone
Despite finding that the doctors had a substantial likelihood of prevailing on the merits, the court did not order the FDA to withdraw or suspend its approval of mifepristone and remove it from the list of approved drugs. Rather, the court stayed the effective date of the FDA's approval in 2000 of mifepristone and all later challenged actions associated with the 2000 approval (for example, the FDA's 2016 changes to the medication abortion restriction, its approval in 2019 of a generic version, and its 2021 regulatory actions). However, the court also stayed its ruling for seven days so that the FDA could request emergency relief from the Fifth Circuit. The court rejected the FDA's request for a stay pending appeal.
Both parties have appealed the district court's ruling to the Fifth Circuit, and the FDA has sought an emergency stay pending appeal.
If the Texas district court's order goes into effect, it would stay the effective date of the FDA's prior approval of mifepristone (and all subsequent challenged actions related to that approval) on a nationwide basis. As the FDA has recognized, however, that outcome is in "significant tension" with the Washington State court's order—and it is currently unclear how the two orders interact. As a result, the FDA has asked the court to clarify the agency's obligations under the Washington State court's order if the Texas district court's ruling takes effect. In the Texas litigation, the FDA asked the Fifth Circuit to enter an administrative stay or grant a stay pending appeal by April 13, so that the government can request relief from the Supreme Court (if needed).
In the meantime, employers that sponsor health plans should identify what, if any, medication abortion drugs their plans cover and consider (particularly with regard to insured plans) whether any plan amendments will be needed if mifepristone is removed from the market. Changes to plan coverage of medication abortion will likely require plan administrators to:
Coordinate with health plan third-party administrators (TPAs), pharmacy benefit managers (PBMs), and other service providers.
Consider the effect on medication abortions provided using telehealth services.