• FDA jurisdiction over prescription drug advertising and promotional labeling
• FDA regulatory standards for advertising and promotional labeling
• Requirements for advertising and promotional labeling
• Special types of advertising and promotional events
• Promotion versus scientific exchange and solicited versus unsolicited requests
• The on-label and off-label controversy
• Direct-to-consumer promotion
• Compliance and other law enforcement agencies

This program is designed for professionals involved in:

• Medical affairs
• Medical communications
• Medical information
• Medical writing
• Field-based medical affairs support (i.e., Medical Science Liaison)
• Medical call center environment
• Regulatory affairs
• Clinical research
• Professional education, training, and development
• Document management/eSubmissions

Upon completion of this module, learners should be able to:

• Identify the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
• Recognize the regulatory requirements for prescription drug advertisements and promotional labeling
• Define the issues concerning the dissemination of information about a prescription drug product prior to its approval
• Determine issues around special types of advertising and promotional events, including the Sunshine Act (better known as Open Payments), and how they relate to HCP customers
• Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
• Recognize corporate integrity agreements
• Define the issues concerning direct-to-consumer advertising of prescription drugs
• Determine the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescriptions drugs