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Articles 1 - 3 of 3
Full-Text Articles in Food and Drug Law
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
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 …
Politically Correct Eugenics, Seema Mohapatra
Politically Correct Eugenics, Seema Mohapatra
Faculty Scholarship
No abstract provided.
Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George
Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George
Faculty Scholarship
This Article concerns the particular regulatory responsibilities only of FDA. It sets to one side the possible regulatory authority of agencies such as the Environmental Protection Agency ("EPA") or the U.S. Department of Agriculture ("USDA"). This approach risks replicating the regulatory fracture introduced during the Reagan Administration and criticized by some scholars,15 but there is a great deal to say about current FDA practices. Out of similar considerations of space and focus, this Article also sets to one side many other important issues that surround GM foods: intellectual property rights; rights to free speech or commercial speech; fair trade …