Biden administration warns SCOTUS of 'disruptive consequences' should abortion pill approvals be struck

Limiting access to the abortion pill mifepristone would have “disruptive consequences” for the Food and Drug Administration (FDA), the product’s sponsors and the women who need access to the drug, the Biden administration told the Supreme Court this week.

In December the top court said it would weigh in this term on the months-long legal battle, which in August 2023 saw the Fifth Circuit Court of Appeals permit mifepristone to stay on the market in recognition of a 2000 FDA approval. However, the appellate court struck later regulatory action related to mail-order prescriptions and, in its written decision, questioned the decisions and authority of the regulatory agency’s experts.

In a written brief outlining its argument for the top court to reverse last year’s Fifth Circuit decision, the administration’s legal team said that mifepristone is demonstrated to be safe for most women, and that its regulatory approvals do not harm the plaintiff physicians who brought the case.

The Fifth Circuit’s decision to partially overturn the regulatory approval “marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use,” the administration wrote. It did so through “a series of errors” that they said contradict the Supreme Court’s precedents and Article Three of the Constitution.

After arguing that the drug’s opponents lack standing, the administration asserted that the FDA’s decisions to change mifepristone’s approved conditions and lower its adverse event reporting requirement in 2016 was lawful, as was its decision to eliminate an in-person dispensing requirement in 2021.

And, even if the drug’s opponents’ arguments “had standing and some likelihood of success,” the administration said that the Fifth Circuit went too far in affirming its “sweeping” preliminary relief, which would roll back mail-order availability of mifepristone prescriptions across the nation.

“There is no equitable justification for allowing parties whose asserted injuries are at best attenuated—and whose relevant claims assert only that FDA failed adequately to explain its actions—to secure disruptive nationwide relief that threatens profound harms to the government, the healthcare system, patients and the public,” the administration wrote.

Danco Laboratories, mifepristone’s manufacturer, also submitted its brief in support of the FDA on Tuesday.

Supreme Court to hear case challenging abortion pill access, FDA authority

Dec. 13, 2023

The Supreme Court announced Wednesday morning that it will weigh in on a months-long legal dispute determining the availability of mifepristone, which is used in more than half of all abortions in the U.S.

The nation’s top court will hear the case this term and presumably would deliver their decision sometime over the summer.

At stake alongside continued access to the drug is the regulatory authority of the Food and Drug Administration. The review also marks the conservative-leaning court’s first true return to the issue of abortion since its decision last year to overturn Roe v. Wade.

The issue at hand stems from a controversial April order from the U.S. District Court for the Northern District of Texas Judge Matthew Kacsmaryk regarding a lawsuit brought by the anti-abortion provider group Alliance for Hippocratic Medicine. The judge’s decision would have rescinded the Food and Drug Administration’s 23-year-old approval of the abortion drug, but was quickly juxtaposed by a contrary decision from U.S. District Judge Thomas Rice, in Washington State.

The months since saw the dispute bounce around a divided appellate court and at one point forced SCOTUS to issue an emergency order maintaining the existing access to mifepristone until a decision was reached.

In August, the Fifth Circuit Court of Appeals eventually permitted the drug to stay on the market — recognizing the FDA’s approval in 2000 and the subsequent approval of a generic version — but struck later regulatory action related to mail-order prescriptions of the drug.

Here, the judges wrote that “FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” with one of the appellate court’s judges filing a separate opinion that advocated rolling back the 2000 approval and questioned deference to FDA’s scientists over elected officials.

The Fifth Circuit Court of Appeals’ partial restriction has been on hold as stakeholders waited to see whether SCOTUS would choose to weigh in. Access to the drug will remain the same as the top court makes its decision.

The list of orders (PDF) released Wednesday morning consolidates the two main cases tackling mifepristone access (FDA, et al V. Alliance Hippocratic Medicine et al; Danco Laboratories, L.L.C. V. Alliance Hippocratic Medicine, et al.) but denies an appeal from the challengers (Alliance Hippocratic Medicine, et al. V. FDA, et al.) seeking to address whether the 2000 FDA approval was lawful.

Industry groups from the healthcare and pharmaceutical sectors as well as the Biden administration have consistently pushed back on the restrictions, which they said would unravel the existing regulatory environment.

Just a few weeks ago, U.S. Solicitor General Elizabeth Prelogar filed a brief on behalf of the FDA arguing that the Fifth Circuit had leveraged a “novel and unworkable” legal framework in its review and said that the lower court had “strayed from settled principles of standing and administrative review.”