The American Pharmacists Association released the following statement in response to the decision in the Alliance for Hippocratic Medicine v U.S. Food and Drug Administration lawsuit file in the US District Court for the Northern District of Texas, regarding FDA approval of mifepristone.
“APhA and our nation’s pharmacists stand behind the FDA review and approval process that relies on evidence-based expert review to establish the safety and efficacy of marketed drugs,” said Ilisa BG Bernstein, PharmD, JD, FAPhA, interim executive vice president and CEO of APhA. “The FDA gold standard for approval has been in place for nearly 120 years and is the basis for pharmacists’ trust and confidence in the medicines they recommend and dispense to patients. The Texas decision does not change this gold standard.”
APhA is currently reviewing the decision. However, this only adds more confusion and complexity to an already complicated state and federal legal and regulatory landscape for pharmacists and patients related to mifepristone.
April 7, 2023
Contact: Ross Hemminger