The last few months have brought an abundance of riches to Foley Hoag’s Advertising and Marketing Practice Group. After expanding the group with the addition of August Horvath in New York, we are pleased to welcome nationally recognized FDA expert Mark Mansour to Foley Hoag’s Washington, D.C. office, where he will complement the firm’s existing FDA expertise and bring decades of experience to a fast-growing practice. Mark’s expertise is broad, ranging from day-to-day counseling to recalls and other crisis management activities, including criminal investigations.
As detailed in the press release announcing his arrival, Mark advises clients in a wide array of industries, including drug and biologicals, medical devices, dietary supplement, and food and beverages. In addition to his FDA experience, Mark has significant experience handling matters pending before the Federal Trade Commission, the National Advertising Division, and in federal court.
We caught up with Mark, who shared his thoughts on what he does, what trends to expect in food and drug law in the next few years, as well as some of the experiences he has had in his years of practice.
Q: How did you get into food and drug law?
A: I worked in the US House of Representatives before law school, and one of my areas of responsibility was the FDA. After law school, I received an offer from a major food industry multinational, and I never looked back. I love the combination of law, science and public policy that characterizes food and drug law. It is a challenge every day to keep up with the scientists with whom we work. More important, the work our clients do helps to save lives and improve the quality of life, and it is a privilege to help get where they need to go from a legal and policy perspective. There aren’t many practice areas where you can make that sort of difference.
Q: What brought you to Foley Hoag?
A: Great lawyers, nice people and culture and the opportunity to work with other FDA and life sciences practitioners. We have a robust, cross-practice life sciences industry group that covers every area of practice relevant to the industry.
Q: What are the major food and drug law trends to watch for in 2018?
A: On the food side, there will be an increase in enforcement activity regarding food safety, with continuing focus on imports. In addition, companies will continue to face competitor and agency scrutiny of their labeling and advertisements. On the drug and device side, I expect FDA to continue to build up its capabilities in order to keep up with the challenges of rapidly evolving technological developments. The areas of personalized medicine and the implementation of systems designed to accommodate real world evidence will be at the forefront of regulatory change.
Q: What would you be doing if you weren’t a lawyer?
A: I love to write, with a focus on books in the public policy area. In fact, I plan to write while I’m practicing law. Writing is a great outlet for my creative side, and it challenges me intellectually in ways that pick up where law practice leaves off. Public speaking is another enjoyable activity. It forces me to organize my thoughts and present them in a way that both informs and, if done well, entertains.
Q: What are your favorite anecdotes from your years as an FDA lawyer?
A: Two come immediately to mind. In one case, I asked a Japanese client for several peer reviewed articles supporting their advertising. They came back with one full page of a Japanese newspaper. After some back and forth, I discovered that it was a series of testimonials for their product. Unfortunately, while those had been reviewed by their peers in the marketing department, they wouldn’t quite meet FTC’s standards.
In the other episode, I was having some difficulty explaining to a CEO why FDA enforcement action should concern him. He was dismissive and remained unconcerned despite my most diligent efforts. Finally, I went online while we were on a conference call and found a most evocative photo of some armed gentleman in windbreakers padlocking a facility that ran afoul of FDA guidelines. A picture in this case was indeed worth a thousand words.