RGA 6440 — Advanced Topics in Advertising and Promotion of Drugs and Medical Devices
2 semester hoursGraduateLecture
Analyzes the regulatory and legal guidelines and standards applicable to the promotion of drug and medical device products in the U.S. market. Includes regulations and policies of the Food and Drug Administration, Federal Trade Commission, Drug Enforcement Administration, Public Health Service, and the Office of the Inspector General, as well as professional guidelines of relevant organizations including AdvaMed, the Accreditation Council for Continuing Medical Education, the American College of Physicians, the Pharmaceutical Research and Manufacturers of America, and the American Medical Association. Explores marketing issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including continuing medical education, advertising of compounding products, off-label promotion, gifts to physicians, and direct-to-consumer advertising. Uses case studies to illustrate and discuss subjects of interest.