Regulatory Courses

The healthcare industry has been a leading target of antitrust enforcement over the past two decades, and most of that has focused on the conduct of pharmaceutical companies. The high cost of prescription drugs is one of the biggest public policy challenges of our time and is now an issue squarely in the cross hairs of federal and state antitrust enforcers. The cases that result feature the application of traditional antitrust principles, formed over the last century, to a unique industry with atypical economics, complex regulatory schemes, and extensive enforcement of patent rights. At every turn, courts and regulators must balance the need to promote price-reducing competition with the need to maintain incentives for massive private R&D investment. This seminar will serve as an introduction to those cases. It will focus on the most common antitrust matters that arise from the competition between branded and generic drugs. It will also survey other hot topics at the antitrust-healthcare intersection more broadly, such as hospital and health system mergers. The course will also serve to develop practical lawyering skills--including how to critically analyze precedent, how to frame and to communicate advice to clients when legal standards are uncertain, and how lawyers shape the law. UPPER-CLASS WRITING REQUIREMENT: A limited number of students may use this class to satisfy the requirement either partially or in full. **A student who fails to attend the initial meeting of a seminar (designated by an (S) in the title), or to obtain permission to be absent from either the instructor or the Registrar, may be administratively dropped from the seminar. Students who are on a wait list for a seminar are required to attend the first seminar meeting to be considered for enrollment.

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SPRG 2026: LAW JD 891 A1, Jan 12th to Apr 22nd 2026

This seminar examines the Food and Drug Administration as an administrative agency combining law and science to regulate activities affecting public health and safety. Topics include testing and approval of pharmaceuticals and medical devices; food safety and nutritional policy; biologics and biotechnology regulation; cosmetic regulation; pricing of and reimbursement for drugs and devices; global aspects of pharmaceutical regulation, US and foreign patent issues, and FDA practice and procedure; jurisdiction and enforcement. A writing project involving research on food and drug issues will be required. RECOMMENDED COURSES: Health Law or Public Health Law, Administrative Law. UPPER-CLASS WRITING REQUIREMENT: This class may be used to satisfy the requirement.

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SPRG 2026: LAW JD 802 A1, Jan 12th to Apr 22nd 2026

The Patient Protection and Affordable Care Act (PPACA), better known as health care reform, is the most important and controversial piece of federal social legislation of this generation. It is also basically an insurance regulatory statute. PPACA establishes a new and complex set of rules governing the operation of the health insurance industry, provides consumers with important rights with respect to access to medical care and imposes obligations with respect to health insurance on both businesses and individuals. The course will look at PPACA and the issues that surrounded its enactment--issues which continue to fuel debate over whether it should modified or repealed. This will be done as part of an examination of the regulatory rules that govern all of insurance industry's products (annuities, auto, home owners' product liability, life insurance, etc). The course also takes a look at the insurance industry's structure and financial performance and at the competitive interactions between the insurance, banking and securities industries. The impact on the industry of the financial crisis of 2008 and the resulting Dodd-Frank reform legislation will be reviewed.

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Health law encompasses the engagement of the legal system with a large and dynamic segment of the U.S. economy. In this class, students will gain a familiarity with how to navigate the statutory and regulatory framework of health law, how to evaluate resources, and how complex and multi-part search strategies may be applied to research problems. Students will also gain a deeper understanding of databases beyond Lexis, Westlaw and Bloomberg, and of current awareness sources. Classes will combine instruction and hands-on exercises using print, electronic, and web-based resources. Students will be evaluated on several grounds, including class participation, regular assignments, and a short paper and presentation. NOTE: This class counts toward the 6 credit Experiential Learning requirement. NOTE: Students may not add this course after the first class has been held. ATTENDANCE REQUIREMENT: A student who fails to attend the first class or to obtain permission to be absent from either the instructor or the Registrar, will be administratively dropped from the class. Students who are on the wait list are required to attend the first meeting to be considered for enrollment.

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SPRG 2026: LAW JD 717 A1, Mar 2nd to Apr 22nd 2026

Public health seeks to prevent unnecessary illness, injury, and death, which law can either facilitate or thwart. The field is transforming from state programs that prevent disease in populations (e.g., vaccination, newborn screening) to federal and international efforts to broadly recognize a population and individual "right to health." This course explores contemporary examples of public health problems such as disasters and emergencies, firearms regulation, regulating commercial speech to prevent consumer deception, and reproductive health. The course offers a framework for identifying and controlling health risks drawing on principles and theories of law, assessment of risk, policy evaluation, and empirical evidence. We will consider how laws at the state and federal levels regulate personal behaviors and products as well as impact the underlying determinants of health. Students will analyze different legal strategies that can be used to guide public health such as governmental nudges through funding, criminal and civil prohibitions, data collection and privacy, marketing restrictions, and taxation.

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SPRG 2026: LAW JD 926 A1, Jan 12th to Apr 22nd 2026