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

8 months
Certification paid
Course by EdX
What will you 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 prescription drugs in the US
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 topics stirring debate over the scope of FDA regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” laws that allow patients to obtain drugs prior to FDA approval
Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients
About the course
Prescription drugs are among the most common health care interventions and have turned some 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 why many 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 will learn the rules and regulations governing the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.
Continuing Medical Education (CME)
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).
The FDA and Prescription Drugs: Current Controversies in Context
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.
Aaron Kesselheim
Aaron Kesselheim
Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital Harvard University
Jonathan Darrow
Jonathan Darrow
Assistant Professor of Medicine, Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital Harvard University
Ameet Sarpatwari
Ameet Sarpatwari
Assistant Professor of Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital Harvard University
Jerry Avorn
Jerry Avorn
Professor of Medicine, Emeritus Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics and Co-Director of the Program On Regulation, Therapeutics, And Law Harvard University
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