FDA Regulatory Practice

Advertising and Promotion

We work closely with our FDA-regulated clients on strategic and compliance issues related to promotional communications and activities. Our regulatory attorneys routinely advise clients on specific promotional pieces as well as overall promotional campaigns, including review of proposed promotional labeling, advertising, infomercials, direct-to-consumer marketing, and other forms of promotion to consumers, as well as health professionals for compliance with FDA and FTC requirements, as applicable.

Our knowledge and experience in this area covers a broad range of FDA-regulated products from prescription and over-the-counter drugs or biologics to dietary supplements, medical devices, and traditional and functional food products. We assist clients in responding to the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, as well as enforcement actions by the FTC as well as state and local enforcement agencies with similar missions to protect consumers from misleading or deceptive advertising, investigations by state attorneys general, Lanham Act lawsuits, and challenges brought before the National Advertising Division (NAD) of the Better Business Bureau. Our attorneys deal with complex issues related to off-label dissemination, the relationship of promotional activities to fraud and abuse cases, and First Amendment Protection applicable to commercial speech.