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Articles 1 - 7 of 7
Full-Text Articles in Law
An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein
An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein
Faculty Scholarship
No abstract provided.
Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile
Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile
Faculty Scholarship
This article advances a new theory of drug regulation that addresses two previously unexamined questions: how law-makers are able to regulate drugs differently irrespective of the dangers the drugs may pose and independent of their health effects, and the process followed to achieve this phenomenon. For example, although tobacco products are the leading cause of preventable death in the U.S. they can be bought and sold legally by adults, while marijuana, a substantially safer drug, is subject to the highest level of drug control. This article posits a conceptual model for making sense of this dissonance and applies this model …
Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz
Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz
Faculty Scholarship
In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …
Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne
Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne
Faculty Scholarship
In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. Such products, said the FDA, are virtually identical to meat or milk from a non-clone. Further, the FDA announced it would almost certainly not require food from clones to be labeled as such. Part I of this article identifies three functions that labels perform, outlines the types of information usually required, and introduces the rule that voluntary label information cannot be misleading. Part II focuses on process information …
Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson
Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson
Faculty Scholarship
At last count, global pharmaceutical spending exceeded $750 billion. Unlike most medical products and services, many pharmaceuticals are sold at a price that greatly exceeds marginal cost. AIDS medicines that retail for over $10,000 per person per year in the United States can be produced generically at a marginal cost of less than $150. Patents and other related IP rights create these significant gaps between marginal cost and retail price, generating many billions of dollars in profits (patent rents) for companies.
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Faculty Scholarship
In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …
Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Faculty Scholarship
This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …