On August 16, 2023, the Fifth Circuit Court of Appeals, in a 93-page opinion, both rejected and affirmed Texas Federal District Judge Kacsmaryk's April 2023 decision to block the FDA's prior approval of the abortion drug known as mifepristone. See, https://www.shipmangoodwin.com/insights/fifth-circuit-court-of-appeals-issues-ruling-in-abortion-drug-court-battle.html. The Fifth Circuit Court's decision to reject the challenge to the FDA's 2000 approval of mifepristone was on the basis that the challenge was time-barred by the statute of limitations.
Nevertheless, the Fifth Circuit affirmed Judge Kacsmaryk's April 2023 stay with respect to: (i) the FDA's 2016 amendments relating to the parameters for prescribing mifepristone; and (ii) the FDA's 2021 decision not to enforce the requirement of in-person dispensing (thereby, allowing prescribing of these medications by telemedicine or dispensing through the mail). The Fifth Circuit's rationale for affirming the stay and reinstating earlier FDA parameters for prescribing mifepristone was their finding that the FDA acted in an arbitrary and capricious manner violating the Federal Administrative Procedure Act.
Basis for Reinstating Earlier Restrictions on Mifepristone:
The Fifth Circuit laboriously revisited the FDA's actions with respect to mifepristone and generics over the last 23 years, focusing on the fact that mifepristone was first approved by the FDA with "black-box" warnings, including:
- Only women whose pregnancies have a gestational age of forty-nine days or less are eligible;
- Only physicians can prescribe Mifeprex;
- All prescribing physicians must be able to assess gestational age, diagnose ectopic pregnancies, and "provide surgical intervention in cases of incomplete abortion or severe bleeding" or have arranged for another physician to provide such care;
- Prescription must occur in person;
- Prescribers must report any "hospitalization, transfusion, or other serious event[s] to the sponsor...;" and
- Three doctor's visits.
In 2007, the FDA imposed a "risk evaluation and mitigation strategy" ("REMS") if it determined that such a strategy was "necessary to ensure that the benefits of the drug outweigh the risks of the drug." See, 21 U.S.C. § 355-1(a)(1). In 2011, the FDA adopted the 2007 "black-box" parameters as the REMS for mifepristone.
In 2016, in connection with a supplemental application by Danco for a generic version of mifepristone and amendments to the 2011 REMS, the FDA amended its REMS as follows:
- Increased the maximum gestational age from forty-nine days to seventy days;
- Allowed non-physicians to prescribe mifepristone;
- Removed the requirement that the administration of misoprostol and the subsequent follow-up appointment be conducted in person;
- Eliminated prescribers' obligation to report non-fatal adverse events;
- Switched the method of administration for misoprostol from oral to buccal; and
- Changed the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg).
In 2019, the FDA approved a generic version of mifepristone by GenBioPro, Inc., relying upon its 2000 approval and the 2016 REMS amendments.
In 2021, during the COVID-19 pandemic, the FDA announced that it would not enforce its in-person dispensing requirements for all forms of mifepristone, allowing it to be prescribed remotely, and in January 2023, the FDA formally removed the in-person dispensing requirement.
The Core of the Fifth Circuit's Decision:
Once the Fifth Circuit concluded that the Plaintiffs had standing to sue the FDA, it found that the FDA's 2000 decision to approve mifepristone was not reopened by subsequent FDA modifications to its approvals, approvals of generics, and or REMS. "Nothing in FDA's approval of the amendments shows that it undertook a "serious, substantive reconsideration" of the 2000 Approval..." Id. at page 39. Accordingly, the Fifth Circuit held that the challenge to the FDA's 2000 approval of mifepristone was untimely and therefore time-barred.
Conversely, the Fifth Circuit did find that the Plaintiffs' challenges to the 2016 REMS amendment and the FDA's decision in 2021 not to take enforcement action with respect to the in-person dispensing requirement were timely challenges. And upon review, the Fifth Circuit concluded that "[b]ecause FDA failed to seek data on the cumulative effect, and failed to explain why it did not, its decision to approve the amendments was likely arbitrary and capricious."
The Fifth Circuit also stated that, with respect to the FDA's decision in 2021 not to take enforcement action with respect to the in-person dispensing requirements, the FDA, "...simply did not tether its actions in December of 2021 to the continued existence of the public health emergency...." and failed to adequately evaluate the risk associated with effectively removing the requirement of in-person dispensing. "It's unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision." Id. at page 48.
Simply put, the Fifth Circuit concluded that there was insufficient evidence, both in 2016 and 2021, to demonstrate that the FDA's relaxation of mifepristone dispensing rules was evidence-based and therefore constituted arbitrary and capricious agency actions. Based upon the foregoing, mifepristone remains available subject to the 2011 REMS or the black-box warnings.
As noted by the Fifth Circuit, its decision remains subject to a prior order by the U.S. Supreme Court should there be a petition for the U.S. Supreme Court's review within 90 days from the Fifth Circuit's August 16, 2023 decision. Of course, if the U.S. Supreme Court denies review, their stay is lifted and the Fifth Circuit's decision goes into effect, and if the U.S. Supreme Court reviews the case, the stay will be lifted once the U.S. Supreme Court sends down its ruling.
Originally published August 17, 2023.
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