Food and Drug Law Commons^™

Food, Drugs, And Droods: A Historical Consideration Of Definitions And Categories In American Food And Drug Law, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This article explores the development and interaction of the legal and cultural categories food and drug from the late nineteenth century to the present. It is based not only on legal and historical research, but also on theories of category formation from the fields of linguistics and psychology.The scope of the Food and Drug Administration's power is defined primarily by the list of product categories over which it has jurisdiction. The statutory definitions of these categories (food, drug, cosmetic, device, and human biological product) thus delineate the outer boundaries of the arena within which the agency operates. The definitions are …

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, …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson

Faculty Scholarship

When I chose the title, Counterfeit Drugs: The Good, the Bad and the Ugly, some of my colleagues at this symposium blanched. They understood counterfeit drugs as Bad and Ugly, but resisted categorizing any counterfeit drug as Good. This article is intended to be provocative, challenging some of the conventional wisdom concerning counterfeit drugs.

We start with the fact that reports about the scope of pharmaceutical counterfeiting are remarkably anecdotal rather than empirical. As a professor once chided me, the plural of anecdote is not data. The FDA and the WHO must undertake comprehensive market surveillance to establish the true …

Reply To Judge Easterbrook: Judicial Discretion And Statutory Interpretation, Steven J. Cleveland

Oklahoma Law Review

No abstract provided.

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

Testing The Limits: Alcohol & Drug Testing For Offshore Employees, Brian Johnston, Tara Erskine

Dalhousie Law Journal

The legal limits of drug and alcohol testing by employers in the Atlantic Canada offshore are not yet entirely clear. To shed light on where these limits may lie, the authors examine the relevant law in the United Kingdom and the United States, together with the law on testing in Canada generally and the applicable provisions of the Accord Acts.

Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

Teaching The Elephant To Dance: Privatizing The Fda Review Process, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Considers the implications of privatizing the Food and Drug Administration's (FDA) review of the safety and efficacy of medical devices and drugs. Concludes that the FDA's flaws - namely, a risk avoidance culture and autocratic style of regulation - can only be accomplished by breaking the agency's monopolization of this review function.

Approval Of Ru-486 As A Postcoital Contraceptive, Kari Hanson

Seattle University Law Review

This Comment argues that if RU-486 were approved as a postcoital contraceptive rather than as an abortifacient, the drug would be of greater overall benefit to women seeking to control their fertility. To support the argument that RU-486 should be approved as a postcoital contraceptive, Part II of this Comment examines the background and development of the drug, the controversy it has engendered, and the drug's recently discovered contraceptive potential. Part III provides a short look at the process by which the FDA approves new drugs and discusses how RU-486 would likely progress through this process. Part IV begins by …

Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo

UF Law Faculty Publications

This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …

The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte

Indiana Law Journal

No abstract provided.