Introduction to Drug Advertising

This program, presented by Darshan Kulkarni, PharmD, MS, Esq., focuses on the legal framework and regulatory requirements governing the advertising and promotion of prescription drugs under the Food, Drug, and Cosmetic Act (FDCA). The course introduces attorneys to foundational definitions such as "label" and "labeling," and the implications of these definitions on FDA-regulated promotional communications. Attendees are guided through the distinction between materials regulated by the FDA and those under the jurisdiction of the Federal Trade Commission (FTC), including how jurisdiction may shift depending on product type and promotional medium. The presentation addresses the three primary types of prescription drug advertising—reminder ads, help-seeking/disease awareness ads, and product claim ads—each of which has unique regulatory requirements and risk profiles. Dr. Kulkarni explains the evidentiary standards required to support promotional claims, including “substantial evidence,” and highlights common enforcement triggers identified by the FDA, such as omission of risk, overstatement of efficacy, and unsubstantiated comparative claims. Finally, the course explores recent enforcement actions, evolving agency expectations around social media and digital communications, and legal trends involving off-label promotion and First Amendment challenges. This session equips legal counsel with the foundational tools needed to identify and mitigate drug advertising risk for their life sciences clients.