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The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs and exposed a gap in the regulation of generic drugs in which no manufacturer is responsible for updating the labeling. This Article argues that to remedy these issues, the Food and Drug Administration (FDA) should use negotiated rulemaking to work with drug manufacturers, consumer representatives, healthcare providers, and other interests to create new drug regulations. Although FDA has not used the negotiated rulemaking process set forth by the Negotiated Rulemaking Act of 1990 to date, the current regulatory environment has several features that suggest it may be well-suited for negotiated rulemaking. In addition, employing negotiated rulemaking to create new drug regulations may yield benefits over conventional notice-and-comment rulemaking and may ultimately produce a more effective and legitimate rule.


Originally published in the Cardozo Law Review, 2014.

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