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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 …


Riley V. California And The Beginning Of The End For The Third-Party Search Doctrine, David A. Harris Jan 2016

Riley V. California And The Beginning Of The End For The Third-Party Search Doctrine, David A. Harris

Articles

In Riley v. California, the Supreme Court decided that when police officers seize a smart phone, they may not search through its contents -- the data found by looking into the call records, calendars, pictures and so forth in the phone -- without a warrant. In the course of the decision, the Court said that the rule applied not just to data that was physically stored on the device, but also to data stored "in the cloud" -- in remote sites -- but accessed through the device. This piece of the decision may, at last, allow a re-examination of …


Tesla, Dealer Franchise Laws, And The Politics Of Crony Capitalism, Daniel A. Crane Jan 2016

Tesla, Dealer Franchise Laws, And The Politics Of Crony Capitalism, Daniel A. Crane

Articles

Public choice theory has long proclaimed that business interests can capture regulatory processes to generate economic rents at the expense of consumers. Such political exploitation may go unnoticed and unchallenged for long time periods because, though the rents are captured by a relatively small number of individuals or firms, the costs are widely diffused over a large number of consumers. The triggering event to expose and mobilize opposition to the regulatory capture may not arise until a new technology seeks to challenge the incumbent technology, thus creating a motivated champion to expose and oppose the regulatory capture and advocate for …