Mark S Brown

Mark Brown is nationally recognized in Food & Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. He advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.

Mark regularly counsels clients on drug safety issues, clinical trials, adverse event reporting, quality systems and manufacturing practices for drugs and devices. He also provides guidance concerning product failure investigations, factory inspections, recalls, product labeling, drug compounding, advertising, promotion, sales and marketing practices, and regularly advises clients on strategies for obtaining FDA approval and clearance for medical products.

Mr. Brown also handles FDA-related issues in product liability and commercial litigation. He was an architect of the preemption defense for both pharmaceutical and medical device clients, developing supporting evidence, briefing and arguing federal preemption motions in various federal and state courts.