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Recent U.S. Supreme Court holdings 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, these rulings have 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 Chapter 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.

Chapter Eight summarizes the federalism safeguards debate, considers the role of negotiated governance, and highlights potential contributions from the academic negotiation literature. Most importantly, Chapter Eight introduces the phenomenon of federalism bargaining among all branches of government. Using the negotiation theorist’s definition, it broadly understands bargaining as “an iterative process of joint decision-making,” encompassing conventional political haggling, formalized methods of collaborative policymaking, and even more remote signaling processes by which state and federal actors negotiate consensus. Reverse-engineering the most successful examples would reveal the very considerations built into the Chapter Six balancing test—rendering bilateral bargaining by the political branches the functional ex ante equivalent of the ex post balancing analysis contemplated there. The federalism bargaining taxonomy charts opportunities for intergovernmental negotiation within various constitutional and statutory frameworks. It begins with the most familiar forms of negotiation used in lawmaking, including conventional negotiations over law enforcement, under the federal spending power, and for exceptions from otherwise applicable laws. It then considers more interesting forms of negotiated policymaking, including negotiated federal rulemaking with state and local stakeholders, federal statutes that share policy design with states, and intersystemic signaling negotiations, by which independently operating state and federal actors trade influence over the direction of evolving interjurisdictional policies. Examples include the 2008 Stimulus Bill, banking and financial services reform, criminal law enforcement, immigration, radioactive waste siting, offshore drilling, hydroelectric dam licensing, medical marijuana, climate governance, and the No Child Left Behind, Endangered Species, Clean Water, Clean Air, Real ID, Coastal Zone Management, and Medicaid Acts.