Drug Prices, Patents, and Politics (Dolbow)
W 1:00PM - 2:59PM
Silverman Hall M28
Why are drug prices so high? This is a question that has vexed commentators and policymakers for years. The pharmaceutical market is complex, and a host of overlapping regulatory regimes influence drug prices. In this seminar, we will explore regulation of the pharmaceutical market and evaluate proposals to reform drug pricing in the United States. We will discuss how various agencies, including the Patent Office, the Food and Drug Administration, the Department of Health and Human Services, and the Federal Trade Commission, all play a role in regulating how pharmaceutical products are developed, approved, and sold. We will discuss how the various regulations across agencies influence how pharmaceutical companies operate in the industry, with a particular focus on pharmaceutical patenting practices. For each regulatory regime, we will consider how the regulations affect drug prices. Then, we will evaluate various policy proposals for drug pricing reform. We will also discuss issues that are likely to arise during implementation of the Medicare price negotiation and rebate provisions included in the Inflation Reduction Act.
No science or engineering background is required, and there are no prerequisites. This course will provide an overview of the patent law and antitrust law concepts that are needed to understand drug pricing reform proposals.
Intellectual Property and Technology Law Learning outcomes: Demonstrate a core understanding of intellectual property law; Perform legal analysis in the context of intellectual property law; Communicate effectively on topics related to intellectual property; Demonstrate an understanding of the interconnection between technology and intellectual property, and how they affect other areas of law and society.
Health Law Learning outcomes: Demonstrate a core understanding of health law and policy; Perform legal analysis in the context of health law and policy; Communicate effectively on topics related to health law and policy; Demonstrate an understanding of the interconnection among health law and policy and issues of access to services, public and private financing of health industries, and the political and economic issues surrounding issues of health law and health services.
Administrative and Regulatory Law Learning outcomes: Demonstrate a core understanding of administrative and regulatory law and the administrative process, including the role of statutory authorization and work of administrative agencies; Perform legal analysis in the context of administrative and regulatory law; Communicate effectively on topics related to administrative and regulatory law; Demonstrate an understanding of the role administrative and regulatory law play in our legal system and in society as a whole.