Two cases concerning the FDA’s approval of Mifepristone, Alliance for Hippocratic Medicine v. United States Food and Drug Administration (AHM v. FDA) and Washington v. United States Food and Drug Administration (WA v. FDA) have caused significant conversations concerning the FDA’s approval processes, statutes of limitation for challenges to approvals, standing, administrative review, and judicial authority. The cases present interesting questions concerning the regulatory process, separation of powers, and the role of judges.

In AHM v. FDA, a judge out of the Northern District of Texas blocked the FDA’s approval of the drug, meaning it could no longer be distributed as an FDA-approved drug. The same day, in WA v. FDA, however, a separate district judge ruled the FDA was being overly restrictive and barred it from altering the regulatory status of Mifepristone in approximately a third of the country. Perhaps due to the drastic split between the courts, both cases have quickly ascended through the courts of appeals.

Join our panel of experts, including Adam Unikowsky --a partner at Jenner & Block who has written substantively on the issue and and whose firm submitted an amicus brief on behalf of numerous organizations in support of the FDA in AHM v. FDA, and Thomas Jipping –a Senior Legal Fellow at the Heritage Foundation where he has published on these issues, in a conversation moderated by Jennie Lichter as they discuss these cases, their substance, and the possible ramifications of future decisions.

Featuring:

Thomas Jipping, Senior Legal Fellow, Edwin Meese III Center for Legal and Judicial Studies, The Heritage Foundation
Adam Unikowsky, Partner, Jenner & Block LLP
[Moderator] Jennie Lichter, Deputy General Counsel, The Catholic University of America