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

Overview

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 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” lawstha…
• Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients

Syllabus 6

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

Skills you'll practise

PharmaceuticalsMedical EducationDrug DevelopmentMarketingDrug AdministrationSafety MonitoringMedical Prescription

Advantages and disadvantages

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Before you start

None

Taught by

• Aaron KesselheimProfessor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital
• Jonathan DarrowAssistant Professor of Medicine, Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital
• Ameet SarpatwariAssistant Professor of Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Brigham and Wo…
• Jerry AvornProfessor of Medicine, Emeritus Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics and Co-Director of…