ACCP Statement on FDA Autonomy and Authority
April 14, 2023
Washington, DC -- In light of recent court rulings and the order issued by the New Orleans-based Fifth U.S. Circuit Court of Appeals on April 12, 2023, the American College of Clinical Pharmacy (ACCP) recognizes the danger of court intervention that undermines the autonomy and authority of the US Food and Drug Administration (FDA), as well as the threat such interventions pose to the rigorous scientific processes and credible expertise that inform FDA drug approvals.
ACCP is a society of clinical pharmacists with a mission to improve human health by achieving medication optimization. Clinical pharmacists practice as integral members of health care teams to ensure patient-centered, evidence-based treatment. The health care team relies on the availability of FDA-approved medications to develop rational, safe, and effective treatment plans.
In keeping with statements published by organized medicine, the pharmaceutical industry, and others, ACCP firmly asserts that the evidence-based processes of assuring medication safety and effectiveness must remain entrusted to the FDA.
The FDA’s Center for Drug Evaluation and Research (CDER) maintains thorough, well-structured processes for determining that a drug provides benefits that outweigh its known and potential risks for the intended population prior to approval. CDER also has a system of post-marketing surveillance and risk assessment programs to identify adverse events that may not have been reported prior to drug approval. The Agency formally evaluates this information to guide necessary revisions in drug labeling, and on rare occasions, to reevaluate the approval status.
Decisions about medication approval, and appropriate access following approval, should be made by experts with the requisite scientific and medical expertise. Recent court actions set a dangerous precedent for circumventing the rigorous FDA drug review and evaluation process. The nation’s drug approval, appropriate use, and labeling decisions must not be subject to political pressures. Judicial decisions should not supersede scientific evidence and the FDA’s formal approach to expert review.