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Full-Text Articles in Food and Drug Law
Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick
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
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 …