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Drug Designs Are Different, Aaron Twerski, J. A. Henderson
Drug Designs Are Different, Aaron Twerski, J. A. Henderson
Faculty Scholarship
No abstract provided.
Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno
Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno
Law Faculty Articles and Essays
This Article discusses drug pricing in the context of federally funded inventions. It examines the “march-in” provision of the Bayh-Dole Act, a federal statute that governs inventions supported in whole or in part by federal funding. It discusses technology-transfer activity as a whole and the often-conflicting roles of the government, academia, and industry. The Article discusses the mechanisms of the Bayh-Dole Act and examines its legislative history. It notes that the Act has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices. The Article …
Making Clinical Trials Safer For Human Subjects, Michael S. Baram
Making Clinical Trials Safer For Human Subjects, Michael S. Baram
Faculty Scholarship
Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …