In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations. Particularly, the Directive 2001/83/EC of ‘the European Parliament and of the Council of 6 November 2001, on the Community code relating to medicinal products for human use,’ establishes the European Regulatory framework, which contains articles dedicated to promotional activities and advertising of medicinal products.
Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively. The information submitted to the OPDP and the APLB must be accurate, ethical, and non-misleading. Additional information about the product’s benefits and risks must be included in the submission.