Influence, Integrity, and the FDA: An Ethical Framework

The authors present an ethical decision framework for distinguishing between legitimate external influences that serve the FDA’s regulatory mission and illegitimate influences that corrupt or undermine the agency’s scientific deliberations. The framework is designed to assist regulators, policymakers, judges, physicians, and the public in evaluating whether external pressures on FDA decisions appropriately advance public health or compromise the agency’s core mission of ensuring drug and device safety and efficacy based on scientific evidence.