Law Commons^™

Shifting Science, Considered Costs, And Static Statutes: The Interpretation Of Expansive Environmental Legislation, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Congress often passes expansive legislation, frequently environmental and public health regulatory statutes, where both the definition of those items being regulated and the mandate have significant breadth. How should these provisions be construed? While it is difficult to establish a model which determines whether to broadly or narrowly construe an expansive statutory provision, factors that impact this choice include the existence of express limitations on the mandate, understandings of congressional intent, the need to avoid regulation that might do more harm than good, the nature of the regulated item, and intervening circumstances such as new understandings in law, policy, or …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …