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Food and Drug Law Commons™

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2013

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Institution
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Articles 91 - 100 of 100

Full-Text Articles in Food and Drug Law

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless Jan 2013

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

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Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes Jan 2013

Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes

Cardozo Journal of Equal Rights & Social Justice

The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.

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Shame, Blame, And The Emerging Law Of Obesity Control, Lindsay Wiley Jan 2013

Shame, Blame, And The Emerging Law Of Obesity Control, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

In using law as a tool to combat the obesity epidemic, legal scholars and policymakers are drawing heavily on the lessons of tobacco control. This Article describes the resulting emergence of "obesity control law" and argues for a radical reorientation of it from a "denormalization" strategy based on the tobacco control experience to a "destigmatization" strategy based on the HIV prevention experience. The war on obesity is nearing a political crossroads. Subsidies and food industry regulations aimed at making our environment more conducive to physical activity and healthy eating are in danger of losing out to cheaper and more politically …

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Who’S Your Nanny, Lindsay Wiley Jan 2013

Who’S Your Nanny, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

INTRODUCTION: In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line "New Yorkers need a Mayor, not a Nanny."1 On television, the CATO Institute's Michael Cannon declared, "This is the most ridiculous sort of nanny state-ism; [ilt's none of the mayor's business how much soda people are drinking." And in news- papers around the country, …

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Undue Process At The Fda, Lisa Heinzerling Jan 2013

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

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Preemption Under The Controlled Substances Act, Robert A. Mikos Jan 2013

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

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Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo Jan 2013

Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo

American University Business Law Review

No abstract provided.

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When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder Jan 2013

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

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Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes Jan 2013

Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes

Articles, Book Chapters, & Popular Press

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …

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The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich Jan 2013

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich

Faculty Scholarship

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic "not show a significant difference" from the reference product, while patent law requires that the generic have "substantial differences" as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed …

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