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# 7 ex-FDA Commissioners Weigh In on Mifepristone
- URL: https://www.fdaweb.com/7-ex-fda-commissioners-weigh-in-on-mifepristone/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:21:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156283

Seven former FDA commissioners (acting and confirmed) have filed an amicus brief with the Supreme Court urging that a lower court ruling restricting access to the abortion drug mifepristone be reversed. The [brief](https://www.supremecourt.gov/DocketPDF/23/23-235/299512/20240201143618529%5F23-235%20and%2023-236%20tsac%20Motion%20For%20Leave%20To%20File%20Brief%20And%20Ac%20Former%20Commissioners%20Of%20The%20U.S.%20Food%20And%20Drug%20Administration.pdf?ref=fdaweb.com) in the closely watched case argues that the Fifth Circuit Court of Appeals should not have substituted its own opinions about mifepristone’s scientific data for FDA’s expert judgments and evidence-based decisions.

“If permitted to stand, the Fifth Circuit’s approach would allow courts to substitute their lay analysis for FDA’s scientific expertise and to overturn the agency’s approval and conditions of use for drugs — even after they have been on the market for decades,” the former regulators argue. “The resulting uncertainty would threaten the incentives for drug companies to undertake the time-consuming and costly investment required to develop new drugs and ultimately hinder patients’ access to critical remedies that prevent suffering and save lives.”

The brief notes that the case is not centered on FDA’s interpretation of applicable law, rather the dispute involves the agency’s evaluation of the scientific data submitted to support an NDA’s approval. “As this court has recognized, judicial review of an administrative agency’s action based on the agency’s evaluation of technical evidence is extremely deferential, and a court may not second-guess an agency’s judgment unless the agency’s decision is arbitrary and capricious,” it contends. “In applying this standard, the court’s role is to determine whether the agency’s decision was ‘reasonable and reasonably explained.’”

If allowed to stand, the former commissioners argue that this new paradigm would take a significant toll on public health. “Successful litigation challenging drug approvals could threaten patient access to necessary drugs and vaccines,” they write in the brief. “It would also adversely impact the effectiveness of healthcare providers who rely on FDA approval when making critical treatment decisions. At the same time, drug companies unhappy with FDA’s denial of their new drug applications could seek court rulings that would risk allowing the introduction of unsafe drugs into the market.”

The former commissioners filing the brief are: **David A. Kessler** (serving 1990–1997); **Jane E. Henney** (1999–2001); **Margaret Hamburg** 2009–2015); **Michael A. Friedman** (1997–1999); **Joshua M. Sharfstein** (acting commissioner 2009); **Stephen Ostroff** (acting 2015–2016, 2017); and **Ned Sharpless** (acting 2019).