Overview
Our attorneys are well versed in the laws and policies governing promotional compliance, which are complex, rapidly evolving, and demand nuanced judgment. We advise our FDA-regulated clients on strategic and compliance matters related to promotional communications and activities. Our knowledge and experience in this area covers a broad range of FDA-regulated products from prescription and over-the-counter (OTC) drugs and medical devices to food, dietary supplements, and cosmetics.
We routinely advise clients on individual promotional pieces as well as comprehensive promotional campaigns, including review of proposed professional and direct-to-consumer materials and activities for compliance with FDA and FTC requirements. We frequently assist clients in responding to Warning and Untitled Letters from the FDA’s Office of Prescription Drug Promotion (OPDP), FTC enforcement actions, investigations by state attorneys general, Lanham Act lawsuits, and challenges brought before the National Advertising Division (NAD).
We also represent a coalition of pharmaceutical, biotech, and medical device companies seeking greater clarity from the FDA on critical issues including dissemination of information about unapproved uses, scientific exchange, the intersection of promotional activities with fraud and abuse enforcement, and First Amendment protections for commercial speech.
Experience
Representative matters include:
- Drafting policies and procedures governing promotional and nonpromotional communications to investors, health care professionals, payors, and patients, including in connection with guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed), new FDA guidance, or other developments. Such policies include those governing activities of medical science liaisons and interactions of sales and marketing personnel with health care professionals.
- Evaluating proposed promotional and nonpromotional communications, including preapproval, label-consistent, and off-label communications, and advising on measures to mitigate legal, enforcement, and execution risk.
- Conducting compliance risk assessments of sales and marketing practices for major pharmaceutical and medical device companies. These assessments generally have two phases, which require a comprehensive review of promotional and sales training materials, as well as employee interviews and substantial document and email review.
- Advising on social media guidelines, the use of social media platforms for product promotion and scientific exchange, and compliance with FTC endorsement and testimonial guidelines.
- Counseling food, dietary supplement, cosmetic, and OTC drug companies on FTC compliance issues, including substantiation requirements.
- Representing companies in response to state attorney general investigations relating to product promotion and under investigation by the FTC in response to FTC access letters and Civil Investigative Demands (CIDs).
- Counseling companies on various legal strategies to address false or deceptive competitor marketing, including cease-and-desist letters, FDA trade complaints, proceedings before the National Advertising Division (NAD), and Lanham Act false advertising litigation.
- Successfully defending pharmaceutical and medical device companies in matters involving allegations of off-label promotion and marketing violations involving various products.
- Representing clients before OPDP, such as by drafting responses to advisory comments and FDA Warning and Untitled Letters.
- Conducting comprehensive assessments of the front- and back-end systems and controls relating to the promotional review committee processes for pharmaceutical and medical device companies.
- Routinely serving as external legal counsel on grant review and promotional review committees for major pharmaceutical and medical device companies.
