The marketing activities of companies in the health care and life sciences sectors draw far more regulatory scrutiny than most other industries. As new and innovative products come to market, the companies behind them must navigate a dense regulatory environment in which any marketing misstep can carry onerous repercussions, both legal and reputational.
Our lawyers take a pragmatic, multidisciplinary approach to the strategic and tactical considerations of our clients’ product marketing efforts. This lets our clients market as aggressively as their risk level allows, while maintaining compliance with regulatory requirements.
Analyzing Marketing Materials
We regularly serve on our clients’ promotional review committees, where they trust us to become part of the team tasked with implementing effective marketing and promotional content while mitigating legal and compliance risks. We advise our clients on pre- and post-approval product communications, helping them navigate their divergent rules for their scientific, promotional, and investor communication. Our team regularly guides clients regarding substantiation of their product claims, ensuring that they comply with U.S. Food and Drug Administration (FDA) and Federal Trade Commission advertising and promotion rules. We also assess their competitors’ communications, and will reach out to regulators on behalf of our clients who are concerned about dubious products or product claims entering the market.
Marketing on Social Media
The rise of social media as a mainstream marketing tool has brought with it regulatory challenges that continue to evolve. Our clients trust us to stay abreast of compliance issues associated with novel marketing platforms and approaches to enable them to quickly maneuver and take advantage of new opportunities. We review their strategies and promotional materials, recommending guardrails to mitigate risks associated with their use. We advise them on the training and use of product influencers, and we help them put in place the controls—both contractual and procedural—that maintain optimal compliance in online environments.
- Represented numerous individual companies and trade associations in their efforts to ensure that health care economic information was appropriately shared while maintaining compliance with FDA requirements.
- Advised pharmaceutical and biotechnology companies on compliance-related issues in order to support the development and commercialization of their products.
- Conducted an assessment of a large, global medical device company’s development and use of health economic and reimbursement information in its promotional materials. Based on the results, we developed policies to ensure the appropriate use of this information and trained the company’s personnel on the regulatory framework governing the use of the information.
- Assisted a large medical device manufacturer in developing and successfully implementing a comprehensive system of Good Promotional Practices that achieved both compliance and the manufacturer’s marketing objectives.
- Helped many companies successfully respond to FDA Warning Letters challenging their promotional activities, often representing them in associated meetings with the FDA and other federal agencies.