Overview

• A divided 2-1 panel held that the FDAAA of 2007 does not clearly override West Virginia’s Unborn Child Protection Act, which bans nearly all abortions including medication abortions with mifepristone.
• Judge J. Harvie Wilkinson, joined by Judge Rossie Alston, wrote that states retain sovereign authority to regulate drug use absent explicit congressional intent.
• In dissent, Judge DeAndrea Gist Benjamin warned that the ban erects barriers to life-saving healthcare and encroaches on the FDA’s role in ensuring medication safety.
• Governor Patrick Morrisey hailed the ruling as a major victory for pro-life laws, while GenBioPro CEO Evan Masingill cautioned of a dangerous ripple effect on access to other FDA-approved medications.
• GenBioPro has announced its intention to seek en banc review or Supreme Court review, setting the stage for further challenges to state restrictions on FDA-approved drugs.