AMCP Statement on Federal Court Decisions Regarding FDA Approvals
Alexandria, VA., April 13, 2023 — AMCP (the Academy of Managed Care Pharmacy) released the following statement in response to conflicting federal court rulings regarding Food & Drug Administration (FDA) drug approval (including Alliance for Hippocratic Medicine v. FDA, a related decision by the 5th Circuit Court of Appeals, and State of Washington v. FDA). While one ruling overturned longstanding FDA approval of a therapy, another explicitly upheld it.
“AMCP is deeply concerned by recent federal court rulings regarding approval status and dispensing guidelines for a therapy repeatedly deemed safe and effective by FDA. Drug approval and related dispensing policies should be the domain of relevant scientific review bodies, such as the FDA, not the courts. Undermining the FDA approval process denies health payers the certainty they need to develop coverage strategies for medication therapies and threatens patient access to and confidence in the care they receive.
AMCP is closely monitoring the situation for further developments.”
AMCP is the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians, nurses, biopharmaceutical professionals, and other stakeholders leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effective and safe medications and other drug therapies. AMCP members improve the lives of nearly 300 million Americans served by private and public health plans, pharmacy benefit management firms, and emerging care models. Visit www.amcp.org.