Former FDA Commissioners Call for Reversal of Mifepristone Decision, Warn of “Catastrophic” Consequences for Access to Medications
Represented by Zuckerman Spaeder, seven former Food and Drug Administration (FDA) commissioners filed an amicus brief calling for the reversal of a district court ruling that blocked the FDA’s decades-old approval of abortion drug mifepristone. The brief set forth how the court erred on both the law and the science and how its ruling poses a significant threat to patient access to medications of all kinds.
The brief was submitted to the Fifth Circuit Court of Appeals by:
• David A. Kessler, M.D., Commissioner (1990–1997)
• Jane E. Henney, M.D., Commissioner (1999–2001)
• Margaret Hamburg, M.D., Commissioner (2009–2015)
• Michael A. Friedman, M.D., Acting Commissioner (1997–1999)
• Joshua M. Sharfstein, M.D., Acting Commissioner (2009)
• Stephen Ostroff, M.D., Acting Commissioner (2015–2016, 2017)
• Norman E. “Ned” Sharpless, M.D., Acting Commissioner (2019)
In explaining that the lower court “blatantly ignored the applicable standard of review,” the former commissioners said, “Instead of reviewing FDA’s approval of mifepristone for reasonableness—as legally required—the district court substituted its own opinion regarding the correctness of FDA’s scientific analysis...” They also went on to say that the ruling got the science wrong: “The lower court’s analysis mischaracterized the record and otherwise largely relied on studies or other information…that on their face were scientifically unsound.”
The FDA’s approval of mifepristone would stand had the court followed the law and considered the wealth of scientifically sound data supporting the drug’s safety, according to the former commissioners. They explained that, “[b]ased on numerous peer-reviewed, clinical studies and more than 20 years of experience with mifepristone, FDA has found that serious adverse events associated with the drug are ‘exceedingly rare.’”
Underscoring the ruling’s dangerous implications, the former commissioners said that it turns Congress’s desired regulatory scheme on its head, opens the door to constant legal challenges of drug approvals, and, if allowed to stand, would threaten the incentives for drug companies to make the “investment required to develop new drugs and provide patients access to critical remedies that prevent suffering and save lives.” The commissioners concluded that “patients in need will ultimately bear the catastrophic consequences of the resulting instability.”
The brief was prepared by Zuckerman Spaeder partners William B. Schultz, who previously served as Deputy Commissioner for Policy at the FDA and General Counsel at the Department of Health and Human Services (HHS), and Margaret “Peggy” Dotzel, who previously served as FDA Associate Commissioner for Policy and Acting General Counsel and Deputy General Counsel at HHS, along with associate Alyssa M. Howard.
The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-cv-00223-Z.