Scott M. Lassman - Kleinfeld, Kaplan & Becker LLP

Scott M. Lassman

Listed in Best Lawyers since 2010
Phone: 202-223-5130

Scott Lassman brings nearly twenty years of experience in food and drug law to the    representation of his clients. Mr. Lassman’s practice focuses on providing strategic advice and advocacy on complex legal, regulatory and legislative matters affecting companies regulated by the Food and Drug Administration (FDA), including pharmaceutical, biotech, medical device, food and cosmetic companies.

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.

Client Comments

"Scott is an up-and-coming powerhouse in the field of food and drug law."

"Scott Lassman is an up and coming power in the field."

"Scott is a very knowledgeable attorney and well versed in the area of FDA law. He has been a valuable resource as well as a good discussion partner. He gives practical solutions to issues and is willing to go the extra mile to give his clients what is needed."

-Chris Cannon
Senior Counsel
Bayer HealthCare LLC

Office Location

1850 M Street, NW, Suite 800
Washington, DC 20036
United States

Practice Areas

Administrative / Regulatory Law

Other Information

Gender: Male