Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
Learn about FDA pharmaceutical regulation
Join Harvard Faculty in this online course to understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.
2-5 hours per week
What You'll Learn
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 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 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.
The course will be delivered via edX and connect learners around the world. By the end of the course, participants will 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
Your Instructor
Aaron Kesselheim
Aaron S. Kesselheim MD JD MPH is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.
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Jonathan Darrow
Jonathan J. Darrow joined the faculty of Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in 2016, following service as Senior Law Clerk to a judge on the United States Court of Appeals for the Federal Circuit, the court that decides all patent appeals involving pharmaceuticals, biologics, and medical devices.
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Ameet Sarpatwari
Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics.
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Ways to take this course
When you enroll in this course, you will have the option of pursuing a Verified Certificate or Auditing the Course.
A Verified Certificate costs $299 and provides unlimited access to full course materials, activities, tests, and forums. At the end of the course, learners who earn a passing grade can receive a certificate.
Alternatively, learners can Audit the course for free and have access to select course material, activities, tests, and forums. Please note that this track does not offer a certificate for learners who earn a passing grade.