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Individual Course

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

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Course Length

8 weeks

2-5 hours per week

Featuring faculty from:

Harvard Medical School LogoHarvard Medical School

Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.

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.

Self-Guided

edX

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  • Do it on your own time
  • Get a certificate, add it to your resume
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Ways to take this course

Audit or Pursue a Verified Certificate

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.

Faculty

Your Instructor

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 at Harvard University

Dr. Avorn is Professor of Medicine at Harvard Medical School and Emeritus Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics and Co-Director of PORTAL. A general internist, geriatrician, and drug epidemiologist, he pioneered the concept of academic detailing and is recognized as a leading expert on this topic and on optimal medication use, particularly in the elderly.

The Division includes faculty with backgrounds in internal medicine and its subspecialties, geriatrics, epidemiology, health services research and policy, law, and biostatistics. His major areas of research include: the scientific, policy, and social factors that shape physicians’ drug choices; the identification and prevention of adverse drug effects; medication compliance by patients; programs to improve the appropriateness of prescribing and drug taking; and pharmaceutical cost-effectiveness analysis.

Dr. Avorn did his undergraduate training at Columbia University in 1969, received his M.D. from Harvard Medical School in 1974, and completed a residency in internal medicine at the Beth Israel Hospital in Boston. He has served as president of the International Society for Pharmaco-Epidemiology and was a member of the National Academies of Science, Engineering and Medicine (NASEM) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Dr. Avorn is the author or co-author of over 500 papers in the medical literature on medication use and its outcomes, and is one of the most highly-cited researchers working in the area of medicine and the social sciences. His book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, was published by Knopf in 2004.

Your Instructor

Ameet Sarpatwari

Assistant Professor of Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University

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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Your Instructor

Jonathan Darrow

Assistant Professor of Medicine, Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University

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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Your Instructor

Aaron Kesselheim

Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University

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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