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Articles 1 - 13 of 13
Full-Text Articles in Law
Local Agriculture Perspectives In The Middle Rio Grande Valley, Cecilia Rosacker-Mccord
Local Agriculture Perspectives In The Middle Rio Grande Valley, Cecilia Rosacker-Mccord
Publications
No abstract provided.
The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck
The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck
O'Neill Institute Papers
This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …
A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck
A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck
O'Neill Institute Papers
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …
A Basin-Wide Approach To Water Management In The Middle Rio Grande Valley, Rolf Schmidt-Petersen
A Basin-Wide Approach To Water Management In The Middle Rio Grande Valley, Rolf Schmidt-Petersen
Publications
No abstract provided.
That’S A Fine Chablis You’Re Not Drinking: The Proper Place For Geographical Indications In Trademark Law, Justin Hughes, Lynne Beresford, Annette Kur, Kenneth Plevan, Susan Scafidi
That’S A Fine Chablis You’Re Not Drinking: The Proper Place For Geographical Indications In Trademark Law, Justin Hughes, Lynne Beresford, Annette Kur, Kenneth Plevan, Susan Scafidi
Faculty Articles
No abstract provided.
Advisory Committee Recommendations - The Utton Center Model Interstate Water Compact, State Bar Center, State Bar Of New Mexico
Advisory Committee Recommendations - The Utton Center Model Interstate Water Compact, State Bar Center, State Bar Of New Mexico
Publications
No abstract provided.
Model Interstate Water Compact, Ken Knox
Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg
Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg
Georgetown Law Faculty Publications and Other Works
The panel decision in Abigail Alliance, which found a constitutional right to use certain medicines that have not received Food and Drug Administration approval, may not survive further review, but it already stands as an important signpost on the road to further deregulation of the drug market. This trend mirrors the evolution of the in vitro fertilization (IVF) industry which is remarkably unregulated although it raises numerous ethical and consumer protection issues. These developments share an obvious libertarian underpinning, but in both cases it is an odd sort of libertarianism, because proponents of unmediated access to drugs and IVF also …
Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai
Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai
Faculty Scholarship
No abstract provided.
Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn
Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn
Faculty Publications
Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended it substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The core concept of this exclusivity as it has been applied by FDA and the courts is that the first generic drug applicant to challenge an innovator's patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. The 180-day exclusivity provision is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA, and it is intended …
Obesity, Public Health, And The Food Supply, Barbara L. Atwell
Obesity, Public Health, And The Food Supply, Barbara L. Atwell
Elisabeth Haub School of Law Faculty Publications
This Article proposes a three-part approach to improve the food supply. Specifically, it explores government taxing and spending, two traditional public health tools, and suggests that both of these governmental powers can be used to make healthier foods more readily reasonable prices, while increasing the cost of less healthy alternatives. Finally, it proposes that we promote a true “food democracy” through the creation of an education and awareness campaign. This campaign would not only better educate Americans about proper nutrition but would also focus on how we can change our entire relationship with food. It would encourage consumption of locally …
Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein
Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein
Faculty Scholarship
No abstract provided.
Fighting Baseball Doping In Latin America: A Critical Analysis Of Major League Baseball's Drug Prevention And Treatment Program In The Dominican Republic And Venezuela, David P. Fidler, Arturo J. Marcano Guevara
Fighting Baseball Doping In Latin America: A Critical Analysis Of Major League Baseball's Drug Prevention And Treatment Program In The Dominican Republic And Venezuela, David P. Fidler, Arturo J. Marcano Guevara
Articles by Maurer Faculty
No abstract provided.