We work closely with our FDA-regulated clients on strategic and compliance issues related to promotional communications and activities. Our regulatory attorneys routinely advise our clients on specific promotional pieces as well as overall promotional campaigns, including review of proposed professional and direct-to consumer materials and activities 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 to medical devices, food, dietary supplements and cosmetics. We frequently assist clients in responding to OPDP Warning and Untitled letters, FTC enforcement actions, investigations by state attorneys general, Lanham Act lawsuits and challenges brought before the National Advertising Division (NAD) of the Better Business Bureau.
Our attorneys are well versed in the laws and policies related to promotional compliance, which are complicated, dynamic and require nuanced judgment. We represent a coalition of pharmaceutical, biotech and medical device companies seeking greater clarity from the FDA regarding its policies concerning issues such as off-label dissemination, scientific exchange, the relationship of promotional activities to fraud and abuse cases and First Amendment protection applicable to commercial speech.
Examples of our advertising and promotion representation include:
- Conducted a number of compliance risk assessments of the sales and marketing practices for our major pharmaceutical and medical device companies. These assessments generally had two phases, which required a comprehensive review of promotional and sales training materials, as well as employee interviews and substantial document and email review.
- Advised a multinational medical device manufacturer on FDA marketing authorization submissions, device safety and labeling issues, and product advertising and promotional strategies.
- Advised one of the world’s leading specialty biopharmaceutical companies on its response to an FDA Warning Letter that raised novel issues related to Internet promotion of drugs, as well as procedural concerns related to submission of marketing materials. The matter was successfully resolved by working with the FDA to craft and implement a corrective action promotion plan, and engaging in an internal review to revise submission procedures and monitoring practices.
- Assisted a pharmaceutical company in the development of company policies related to activities of medical science liaisons and interactions of sales and marketing personnel with health care professionals.
- Successfully defended multiple pharmaceutical and medical device manufacturing companies in alleged claims of off-label promotion and marketing violations involving various products.
- Represented numerous companies under investigation by the FTC in response to FTC access letters and Civil Investigative Demands (CIDs).
- Routinely counsel food, dietary supplement, cosmetic, and OTC drug companies on FTC compliance issues, including substantiation requirements.
- Routinely conduct due diligence on advertising and promotion related compliance applicable to FDA-regulated companies.
- Represented numerous companies in NAD challenges.
- Represented companies in response to state attorney general investigations relating to product promotion.
- Conducted a comprehensive assessment of the front- and back-end systems and controls relating to the promotional review committee process for one of the world’s largest research based pharmaceutical companies.
- Conducted an in-depth review of telesampling and video-detailing systems and controls for a major pharmaceutical company.
- Advised several pharmaceutical and medical device companies on the development and use of mobile medical applications, message boards, and other social media platforms.
- Served as external legal counsel on grant review and promotional review committees for major pharmaceutical companies.