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Articles 1 - 6 of 6
Full-Text Articles in Law
The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis
The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis
Law Faculty Scholarly Articles
A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …
Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Contributions to Books
This chapter, new in the third edition, concerns how Congress, the Food and Drug Administration, and the courts have treated the definitions of "food," "drug," "cosmetic," "device," and "human biological product." The scope of FDA's power is delineated almost entirely by the list of product categories over which it has jurisdiction. As the materials in this chapter show, the product definitions are strikingly broad and thus confer jurisdiction over a vast range of goods. Furthermore, the definitions are remarkably plastic, providing FDA with great flexibility to decide whether and how to regulate products. Sometimes FDA has interpreted the definitions expansively, …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Ariel Katz
Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …
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 …
Extra-Judicial Decision Making For Drug Safety And Risk Management: Evidence From The Fda, Hazel Mcmullin, Andrew B. Whitford
Extra-Judicial Decision Making For Drug Safety And Risk Management: Evidence From The Fda, Hazel Mcmullin, Andrew B. Whitford
Northwestern Journal of Technology and Intellectual Property
No abstract provided.
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Journal of Law and Health
The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …