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Harvard University

Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

Harvard University via edX


Prescription drugs are among the most common health care interventions and have turnedsome once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about whymany conditions,such as Alzheimer’s disease, remain without adequate 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.

This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You willlearn the rules and regulationsgoverning the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.


  • Module 1: Overview and history of the FDA
  • Module 2: Drug development and approval
  • Module 3: Drug pricing in the United States
  • Module 4: Marketing strategies
  • Module 5: Post-approval evaluation
  • Module 6: Emerging medical technologies

Taught by

Aaron Kesselheim, Jonathan Darrow and Ameet Sarpatwari


5.0 rating, based on 2 Class Central reviews

4.8 rating at edX based on 23 ratings

Start your review of Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

  • Carolina Zúñiga
    A bit long and repetitive, but totally worth it. The analysis is deep and smart, and it doesm t fear controversy.
  • Profile image for Preya Patel
    Preya Patel
    I found this to be a great, challenging course. The topics were worthy of discussion in my opinion. Learned a lot. I think this will be beneficial for other healthcare providers/professionals

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