The U.S. Food and Drug Administration (FDA) is one of the most powerful administrative agencies in the federal government: the agency regulates 25 cents of every dollar spent in the United States. This course explores the legal and policy issues concerning the history, ambit, and practice of the FDA’s regulatory powers. More specifically, the course covers the following topics: the history of the FDA; the scope of the agency’s constitutional and statutory authority; the interaction of the agency with industry and intellectual property law; legal and ethical issues concerning the approval of drugs and medical devices; the effect of FDA regulation on health care; and recent difficulties concerning the approval of biologic drugs and genetic testing.
On a doctrinal level, this upper level course involves common-law reasoning, statutory interpretation, constitutional and administrative law, ethics, and the pharmaceutical and medical device businesses, both of which have a substantial presence in the New York metropolitan area. The course is ultimately designed to benefit students interested in intellectual property, health care, and other fields.
Recommended for the Following Professional Pathways: Government/Public Sector; IP/Copyright and Trademark; Corporate Transactions and Governance; Health Care Management and Compliance