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

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.

• 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” lawsthat 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