Areas of Focus

This course analyzes the legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries. Innovation in biopharmaceuticals, medical devices, health services, and health care delivery is central to the heavily regulated life sciences sector, and thus the sector offers a window into multiple intersections of scientific innovation, regulatory policy, and law. Innovation in this sector is also shaped by multiple bodies of law (e.g. intellectual property law, FDA law, federal and state-based insurance and professional regulation, antitrust, tax), each with its own private and public constituencies, and therefore offers an opportunity to assess how different bodies of law approach the common issue of innovation. Although this course focuses on innovation in the life science industries, this focus will produce lessons for innovation policy in other regulated and less-regulated industries. 

Introduction to basic principles of food and drug laws and examination of how significant doctrines of constitutional, administrative, and criminal law have been elaborated and applied in the food and drug context. The United States Food and Drug Administration has a pervasive role in American society: It is often said that the agency regulates products accounting for twenty-five cents of every dollar spent by consumers. Exploration of the complex interplay of legal, ethical, policy, scientific, and political considerations that underlie the FDA's regulatory authority, its policymaking, and its enforcement activity.

A survey of the legal environment of the health services industry in a policy perspective, with particular attention to the tensions and trade-offs between quality and cost concerns. Topics for selective study include access to health care; private and public programs for financing and purchasing health services; the economics of health care and health care costs; the role of professionalism versus the new commercialism in health care; the legal and tax treatment of not-for-profit corporations; regulation of commercial practice in professional fields; fraud and abuse in government programs; the application of antitrust law in professional fields; the internal organization and legal liabilities of hospitals; public regulation of institutional providers, including certification of need; personnel licensure; private personnel credentialing and institutional accreditation; liability for medical accidents; legal liabilities associated with the administration of health benefits; and public regulation of managed-care organizations. Study of the diverse legal problems encountered by a single industry, particularly one as important, complex, and intrinsically interesting as health care, may appeal to students generally interested in public policy and in law and economics as well as those with specific interests in the health care field.

This two-credit seminar examines the law and policy governing the availability, price, and development of medicines worldwide, providing an overview of the international legal frameworks, national regulations, and innovation policies affecting access to existing medicines and the development of future treatments for global health. It encourages students to critically examine current international law governing pharmaceutical innovation and to engage in efforts to improve incentives for the pharmaceutical sector to better meet global health needs. This seminar is open to non-law graduate students depending on space and prior experience.

SciReg Lab teaches students about the use of emerging science and technology in the regulatory agencies through the drafting and submission of comments to federal rule-makings. The comments will be unaligned with any party and are intended to provide the regulatory agencies with unbiased, current, accurate and coherent information about the science underlying the proposed rule. The course is cross-listed in the Law School and Graduate School and the students will be drawn from the sciences, ethics, policy and law to work in interdisciplinary teams. The course will begin with a brief overview of notice-and-comment rulemaking, and how to translate scientific information into the language of courts and agencies. The ethical issues presented by this process will be an important component of the course content. With the assistance of faculty, the students will track pending rulemakings and select proceedings in which to file a comment. A background is science is recommended, but not required.