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, including adequate labeling, should lie with the drug's manufacturer, whether it is a generic or brand-name drug. However, U.S. Supreme Court decisions at the time indicated that only brand-name drug 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 employ negotiated rulemaking, involving various stakeholders, to reform generic drug regulations. This approach, though not previously used by the FDA, was suggested to potentially offer advantages over traditional rulemaking methods, leading to more effective and legitimate regulations.