Health Law and Policy Commons^™

Health Courts And Malpractice Claims Adjudication Through Medicare: Some Questions, Timothy Stoltzfus Jost

Scholarly Articles

No abstract provided.

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.

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

Pace 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 Scholarship

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 ...

Abortion, Equality, And Administrative Regulation, Gillian E. Metzger

Faculty Scholarship

This symposium essay argues that administrative regulation of abortion and reproductive rights deserve closer study. Administrative regulation of abortion is overwhelmingly health regulation; the focus is on abortion as a medical procedure, and the government's only stated interest is protecting the health of women obtaining abortions. Such regulation is becoming increasingly common, and is worthy of greater attention on that ground alone. But in addition, and of particular relevance to this symposium on reproductive rights and equality, administrative abortion regulation demonstrates the difficulty in successfully challenging abortion restrictions as unconstitutional gender discrimination. Given general medical agreement that early abortions ...