240 Members of Congress, 50 Senators and 190 House Representatives, commented on the fact that Congress has endowed the FDA’s experts with broad power to review and approve drug applications. The FDA, after a thorough and comprehensive review process prescribed and overseen by the legislative branch, determined that mifepristone is safe and effective. The nonpartisan Government Accountability Office reaffirmed that FDA’s approval process was proper and undertaken in accord with standard procedures. The district court’s order, which purports to stay mifepristone approval, threatens the FDA’s longstanding statutory framework. The resulting uncertainty will impact researchers, healthcare providers, and patients who rely on the integrity and stability of the FDA’s rigorous science-based drug approval process. The members express their grave concern that the District Court’s decision will reduce access to abortion even in states that allow it and exacerbate the ongoing reproductive health crisis.
This brief was one of many filed in support of the FDA in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.