Unequal Protection Under the Law: Why FDA Should Use Negotiated Rulemaking to Reform the Regulation of Generic Drugs

The document argued that the responsibility for ensuring drug safety should lie with the manufacturer, whether the drug is generic or brand-name. However, U.S. Supreme Court decisions indicated that only brand-name manufacturers were responsible for label content, leaving a regulatory gap for generic drugs. This gap was exacerbated by the Court's preemption of state law failure-to-warn claims against generic manufacturers, removing consumer protections. The article proposed that the FDA should use negotiated rulemaking, involving various stakeholders, to reform drug regulations. This approach, though not previously used by the FDA, could be more effective and legitimate than traditional rulemaking methods.