Navigating the FDA Communications Guidances: Best Practices for Pharmaceutical and Medical Device Sales and Marketing Communications with Physicians

On October 4, 2017, Michael C. Zogby and Chanda A. Miller of the firm’s Products Liability and Mass Tort practice group and Pharma and Life Sciences Industry Group presented “Navigating the FDA Communications Guidances: Best Practices for Pharmaceutical and Medical Device Sales and Marketing Communications with Physicians,” which was sponsored by the Products Liability Committee and Drug, Device and Biotechnology Committee of the International Association of Defense Counsel (IADC). Mike and Chanda discussed new developments concerning how pharmaceutical, biologic, and medical device companies, including sales and marketing professionals and detail representatives, communicate about their products, and how those developments may impact companies in litigation.

In 2017, the FDA published draft guidance documents, a First Amendment Memorandum, and rules on the "intended use" definition in the Food, Drug, and Cosmetics Act (FDCA), which is the basis for determining whether a product is regulated by the FDA. As sales and marketing witnesses are thrown to the forefront of products liability litigation, their communications with physicians often become the subject of depositions and trial testimony. Mike and Chanda addressed First Amendment case law, FDA rulemaking, and legislative activities. They explored acceptable communications, industry comments, FDA rules, risk assessment, First Amendment implications, and how to prepare witnesses for deposition and trial. The IADC is comprised of the world’s leading corporate, litigation, and insurance attorneys and executives. Members represent the largest corporations around the world, including the majority of companies listed in the FORTUNE 500. The association is limited to 2,500 invitation-only, peer-reviewed members and their clients.