What you'll learn

  • Key controversies over how prescription drugs are developed and marketed, and why those controversies exist

  • The FDA — its history, public health role, and rules affecting the US prescription drug market

  • The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval

  • The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs

  • Safety evaluation of prescription drugs using “real world” data

  • Current debates over the scope of FDA regulation, such as dietary supplements, different special classes of prescription drugs, and “right to try” laws relating to experimental drugs with limited testing

Course description

Prescription drugs are among the most common health care interventions and have turned many once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients and physicians in the US struggle with increasing costs and express concerns about why certain conditions like Alzheimer’s disease remain without therapeutic options.

At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.

In this course, we will investigate the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will understand the rules and regulations related to the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating the pharmaceutical market.

Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 Credit™ (2 credits).

Course Outline

Overview and history of the FDA

Drug development and approval

Drug pricing in the United States

Marketing strategies

Post-approval evaluation

Emerging medical technologies


Associate Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Harvard University
Instructor in Medicine, Program On Regulation, Therapeutics, And Law, Harvard University
Instructor in Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Harvard University

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