Former FDA commissioners argued that Trump-era religious exemptions for birth control coverage jeopardize public health and distort medical science, in an amicus brief filed Monday with the Third Circuit.
The filing marks a mounting reescalation in the decade-long battle over the Affordable Care Act's contraceptive mandate, which may soon return to the U.S. Supreme Court.
Former Commissioner Dr. Margaret Hamburg, former acting Commissioner Dr. Stephen J. Ostroff, and former Associate Commissioner Dr. Peter Lurie argue that the Trump administration distorted medical science around contraceptives in the final FDA rules to justify the sweeping religious and moral exemptions.
"Defendants have attempted to use known side effects as the rationale to change their position and cast doubt on the safety and effectiveness of an entire category of FDA-approved products, all without conducting any of the same rigorous, scientific evaluation that led to their approval and ongoing marketing," the former commissioners wrote in their brief.
The rules, which were vacated by a Pennsylvania federal court last summer, allow employer-sponsored health plans to bypass the requirement to cover FDA-approved contraception at no cost to employees.
The former commissioners argue the rules prioritize religious objections over medical necessity and should not be resuscitated.
If the Little Sisters of the Poor, the religious order intervening in the case, loses this appeal, the U.S. Supreme Court may be called on to decide whether government policy can legally prioritize "sincerely held beliefs" over established scientific consensus.
According to federal agencies' own estimates published in the Federal Register, a win for the employers could strip no-cost birth control from over 100,000 women.
The former FDA officials emphasized that the "uncertainty" that the government claims regarding the safety and efficacy of FDA-approved birth control do not meet the legal standards required by the Administrative Procedure Act to change government policy.
They accused the administration of using "cherry-picked" data to exaggerate health risks while ignoring decades of rigorous FDA monitoring.
The legal saga began in 2017 when New Jersey and Pennsylvania challenged the new exemptions. While the U.S. Supreme Court affirmed the government's statutory authority to create such exemptions in 2020, it left the door open for claims that the rules were "arbitrary and capricious."
In August, U.S. District Judge Wendy Beetlestone ruled exactly that, vacating the exemptions as invalid.
The district judge held that government agencies promulgated the rules based on misinterpretations of the law and voiced her concerns with the government's backtracking as to the safety and effectiveness of birth control.
"Indeed, in the face of prior, contradictory findings that contraception is safe and effective, and without evidence to refute said conclusions, the agencies' change-in-position 'runs counter to the evidence,' and for that reason, too, the rules are arbitrary and capricious," Judge Beetlestone wrote.
On appeal, the government argued that Judge Beetlestone was "circumventing the Supreme Court's decision by dressing up old (and rejected) arguments in new garb," while the Little Sisters of the Poor claimed that without the exemptions, the mandate discriminates against its Catholic faith.
The states, in their brief, argue the agencies manufactured a medical controversy that did not previously exist — claiming "significantly more uncertainty and ambiguity" on the "health effects of contraception and pregnancy" — while declining to take a position on empirical questions.
"This 'just-asking-questions' approach does not constitute agency expertise," the states argued.
The former FDA officials agreed, stating in their amicus brief Monday that the Trump administration manufactured "scientific uncertainty" about the safety and efficacy of contraceptives in direct contradiction of the FDA's own approval process.
FDA approval is a "rigorous process that ensures the safety and effectiveness of drugs and devices," the former commissioners said. They argue that the final rules fail to identify any novel health concerns associated with covered contraceptives or any data supporting "uncertainty" as to the health effects or effectiveness of these drugs.
Representatives and counsel for the parties did not immediately respond to requests for comment Tuesday.
Former FDA official amici are represented by Lisa S. Mankofsky of the Center for Science in the Public Interest.
New Jersey is represented by the state's Attorney General Jennifer Davenport, Solicitor General Jeremy M. Feigenbaum, Deputy Solicitor General Shankar Duraiswamy, and Deputy Attorneys General Janine S. Balekdjian, Joshua P. Bohn, and Meghan Musso.
Pennsylvania is represented by General Counsel of the Commonwealth of Pennsylvania Jennifer C. Selber, Executive Deputy General Counsel Michael J. Fischer, and Deputy General Counsel Aimee D. Thomson.
Intervenor-appellant Little Sisters of the Poor are represented by the Becket Fund for Religious Liberty, Paul D. Clement and Erin E. Murphy of Clement & Murphy, and Nicholas M. Centrella of Clark Hill.
The federal appellants are represented by Assistant Attorney General Brett A. Shumate, Deputy Assistant Attorney General Eric D. McArthur, and Appellate Staff Civil Division attorneys Sharon Swingle, Derek Weiss, and Jacob Christensen.
The case is Commonwealth of Pennsylvania et al. v. President United States of America et al. and Little Sisters of the Poor Saints Peter and Paul Home, case numbers 25-2575 and 25-2662, in the U.S. Court of Appeals for the Third Circuit.
Mar 3
Deal Summary
