Description
This professional certification in pharmaceutical sales and marketing is designed to train professionals on Good Promotional Practices (GPP). Described within are the regulatory guidelines which govern companies, their employees, and contractors on how to sell and market drugs in the United States.
The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases. In this program, we identify the laws and guidance that apply, and we provide information that will help companies to market their products without incurring penalties.
Furthermore, advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements, as per FDA 21 CFR Part 202. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this program and its companion courses will help you to advertise and promote your products without incurring legal or regulatory sanctions.
In this program we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.
The program moves on to explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.
Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.
In addition to those that apply to all advertising and promotion of prescription drugs, specific regulatory requirements and industry/regulatory guidance apply to DTC advertising and promotion, including online promotion, and we also discuss these in this program.
This program provides information and guidance from:
- Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER)
- Anti-Kickback Statute
- False Claims Act
- FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
- PhRMA Code – Pharmaceutical Research and Manufacturers of America Codes
- REMS – Risk Evaluation and Mitigation Strategy
- PHS Act – Public Health Service Act
