BioCentury
ARTICLE | Politics, Policy & Law

Upholding mifepristone decision would be ‘catastrophic,’ former FDA commissioners say

Former agency leaders warn of instability if judges second-guess FDA decisions on science, medicine

May 2, 2023 9:58 PM UTC

Seven former FDA commissioners or acting commissioners have cautioned a federal court that to preserve the integrity of the regulatory paradigm that has been in place for eight decades, it must overturn a lower court ruling invalidating the approval of the abortion drug mifepristone. Allowing the ruling to stand would upend the regulatory framework for medical products, resulting in “catastrophic consequences” for patients, they wrote in a brief filed with the U.S. Fifth Circuit Court of Appeals.

The brief was filed ahead of oral arguments that are scheduled to start on May 17. ...