Mr. Lassman combines a strong public policy background with a deep understanding of the real-world challenges faced by regulated industry. Mr. Lassman has particular expertise on pharmaceutical lifecycle management and competition issues, advertising and promotion, drug and device labeling, drug and device product approval and FDA regulatory policy. He strives to achieve his clients’ business objectives through both counseling and advocacy and has extensive experience navigating FDA’s complex administrative processes and structure. For example, Mr. Lassman is intimately familiar with FDA’s Citizen Petition process, including the new requirements imposed on certain drug-related petitions under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Moreover, he has developed significant litigation experience against FDA, including successfully obtaining preliminary and permanent injunctive relief in drug and device cases.Prior to re-joining KKB in 2009, Mr. Lassman served as Chair of the FDA Practice Group of a large, international law firm and as Senior Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), where he was responsible for FDA regulatory and policy matters. While at PhRMA, Mr. Lassman played a leading role in negotiating the $400 million Prescription Drug User Fee Act (PDUFA IV) with FDA; working to enact FDAAA; and developing and advocating industry positions on drug safety, direct-to-consumer advertising, use of citizen petitions, clinical trial disclosure, and implementation of the Hatch-Waxman provisions of the Medicare Modernization Act. In 2007, he received the PhRMA Board of Directors Exceptional Service Award, the highest award bestowed to a PhRMA employee, for his work on PDUFA and FDAAA. Mr. Lassman also was responsible for implementation of the PhRMA Code on Interactions with Healthcare Professionals, sometimes referred to as the PhRMA marketing code.
Recognized in The Best Lawyers in America for work in:
- Administrative / Regulatory Law
- FDA Law