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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. Prescription Drug Regulation, Cost, and Access
Continuing Medical Education (CME)
Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn 2 AMA PRA Category 1 Credit
LEARNING
- 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
SYLABUS
Overview and history of the FDA
Drug development and approval
Drug pricing in the United States
Marketing strategies
Post-approval evaluation
Emerging medical technologie
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