Michael C. Zogby and Chanda A. Miller, partners in Drinker Biddle’s Products Liability and Mass Tort 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,” on September 26, 2018, for the American Bar Association. Mike and Chanda discussed First Amendment case law, FDA activity, and 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 and at trial.
In 2017 and 2018, the FDA published draft and final 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 through the lens of a trial lawyer. They also explored acceptable communications, industry comments, FDA rules, and First Amendment implications. The FDA’s final Guidance entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers,” which was published in June 2018, is available here. The FDA’s final Guidance entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” which was also published in June 2018, is available here.
The roundtable presentation was co-sponsored by the ABA Section of Litigation’s Products Liability Committee and Mass Torts Committee. Katherine McBeth, associate in the Products Liability and Mass Tort Group, provided excellent research and support for the presentation.