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Food and Drug Law Commons

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Full-Text Articles in Food and Drug Law

Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland Oct 2023

Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland

Life of the Law School (1993- )

No abstract provided.


Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi Jan 2020

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …


Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick Oct 2016

Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick

Pediatrics Faculty Publications

No abstract provided.


Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai Mar 2016

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …


Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti Jun 2014

Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti

Law Faculty Publications

No abstract provided.


A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue Jan 1998

A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue

Articles

The first criticism is that the proposed resolution would not require manufacturers and, in tum, consumers to pay anything approaching the true total costs of cigarettes, costs that we estimate to be at least $7 per pack, a number that is considerably higher than other estimates that have been reported in the media. Our estimate includes some, but not all, of the costs borne ultimately by smokers themselves, by smokers' insurers, and by individuals injured by second-hand smoke. It includes only future costs and excludes many of those. So, for example, the figure includes neither the health-care costs that have …


Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore Jan 1998

Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore

Articles

Although nothing is certain in Washington, sweeping federal legislation in the cigarette area is more likely now than has ever been the case. Congress is currently considering several proposals for comprehensive federal regulation of the cigarette market, a market that has until now gone largely untouched by government intervention. Among those proposals, the one that has received the most attention, and the one that in fact motivated policy makers to look anew at the problems posed by cigarettes, is the proposed national tobacco resolution (the "Proposed Resolution"). The Proposed Resolution, which has been advanced by a coalition of state attorneys …