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Full-Text Articles in Food and Drug Law
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Law & Economics Working Papers
Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …
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 …