Drugs, Biologics, and Devices: FDA Regulation, Intellectual Property, and Medical Products in the American Healthcare System
This article examines the basic framework of the U.S. Food and Drug Administration (FDA)’s approval process for drugs, biologics, and medical devices within the broader context of the country’s healthcare system. The article also discusses intellectual property protections and statutory exclusivity periods for medical products and their effect on the market entry of follow-on therapies. It then considers a number of current developments shaping FDA regulation of pharmaceuticals and medical devices, including the rise of personalized medicine, the strengthening of First Amendment commercial speech protections, and the agency’s expanding involvement in the practice of medicine. Finally, the article examines how the FDA must increasingly share its gatekeeping role with third-party payers and considers the agency’s future in light of this phenomenon.
Maxwell J. Mehlman
This chapter explores the legal implications of the entire human genome, or “genomics.” It begins with an overview of scientific aspects of human genomics and a discussion of the history of the legal, ethical, and policy challenges raised by the science of genomics. It looks at the eugenics movement in the early twentieth century and state sickle-cell screening programs targeting African Americans in the 1970s. It then considers the basic rules governing genomic research and the legal issues raised by genomic research on human subjects, so-called incidental findings, ownership of DNA samples, government oversight, and genomic research aimed at altering the human germ line. The chapter examines whether discoveries arising from genomic research are entitled to intellectual property protection, or whether they can be patented; genomic screening and testing; liability in genomic testing; genomic therapy and enhancement; forensics; and genomic discrimination. Finally, it outlines future prospects for genomic research.