26 Pages Posted: 12 Nov 2012
Date Written: November 10, 2012
Commercial free speech, recognized by U.S. federal courts in recent years in the pharmaceutical marketing context, has granted the biopharmaceutical sectors expansive marketing discretion and instilled industry independence from government regulation. However, after three decades of aggressive comingling of government, industry, and academia in biopharmaceutical research and development, the U.S. Government has announced an intervention to lift it out of doldrums of failure. The National Institutes of Health (NIH) has proposed a billion-dollar center to intervene in commercial drug development with the objective of lifting it out of a fifteen-year slump in productivity. This article questions the role of the U.S. government in human clinical research, drug development, and biopharmaceutical marketing post completion of the Human Genome Project (HGP). How much leeway should the biopharmaceutical sectors be granted under the doctrine of commercial free speech given the direct government investment in these sectors’ research and development and now intervention to make them commercially productive and to meaningfully improve human health? Should comingling government and industry give the U.S. government more leeway in regulating the outcome of the endeavor, especially when human health is at issue?
Keywords: Pharmaceuticals, Government Funding, Technology Transfer, Biotechnology, Food and Drug Administration, International Conference on Harmonisation, Manhattan Project, Human Genome Project, NIH, National Institutes of Health, Francis Collins
JEL Classification: A00, B25, L50, I00, I18, O30, O40, O51, P10
Suggested Citation: Suggested Citation
Malinowski, Michael J., Government RX - Back to the Future in Science Funding? The Next Era in Drug Development (November 10, 2012). University of Louisville Law Review, Vol. 51, No. 101, 2012. Available at SSRN: https://ssrn.com/abstract=2173764