The Food and Drug Administration, Department of Justice, Federal Trade Commission, state attorneys general and other agencies are increasingly taking pharmaceutical, medical device, and food and cosmetics companies to task for advertising and promotion practices deemed or suspected of being false, misleading or otherwise unlawful. In response, many FDA-regulated businesses are taking a defensive approach to minimizing risk.
At Hunton & Williams LLP, we acknowledge that a strictly conservative approach to product advertising and promotion offers certain benefits; however, we also believe that a more nuanced and informed approach can assist clients in moving beyond simple risk avoidance toward more proactive, effective ways of marketing their products.
We routinely counsel clients in the following areas:
- Promotional material review, such as sales aids, journal advertisements, and websites
- Promotional activities, such as detailing, advertising and conducting promotional events
- Direct-to-consumer advertising
- Social media campaigns
- Off-label and pre-approval promotion
- Scientific exchange
- First Amendment protection of commercial speech
- Organizing and maintaining promotional review committees
- Prescribing and usage disclosures
- Interactions with FDA’s Office of Prescription Drug Promotion, including launch and routine submissions of promotional materials
- FDA investigations and actions
- FTC investigations and actions
- State consumer protection and unfair trade practices laws
- Lanham Act lawsuits and proceedings before the National Advertising Division of the Better Business Bureau
To help clients develop more effective internal practices and improve compliance, we have developed a range of in-house training programs that cover the full scope of legal and commercial requirements in the advertising and promotion of FDA-regulated products. These training programs are not limited to our business clients; in conjunction with the Food and Drug Law Institute, we also provide training and education to FDA employees who are directly responsible for reviewing and enforcing the laws and regulations that apply to our clients’ operations.
Our promotion and advertising practice and experience extends beyond the United States. Our experienced Brussels-based regulatory and life sciences lawyers also work with multinational and European companies to ensure compliance with regulatory schemes across EU member states. Promotion and advertising rules being mainly national, the European team collaborates with a network of local boutique law firms that specialize in regulatory matters to meaningfully advise on, and help orchestrate, European-wide promotional and advertising campaigns, including over the Internet.