profile

Scott Lassman brings nearly twenty years of experience in food and drug law to the representation of his clients. His practice focuses on providing strategic advice, counseling, and advocacy on complex legal, regulatory and legislative matters affecting pharmaceutical, biotech, medical device, cosmetic and dietary supplement manufacturers.

Mr. Lassman has substantial expertise on pharmaceutical lifecycle management and competition issues, including the Hatch-Waxman Act and the new biosimilars law. Other areas of specialty include advertising and promotion, drug and device product approval, clinical trial requirements, corporate due diligence, and FDA regulatory policy. Mr. Lassman is adept at navigating FDA's complex administrative processes and structure, including FDA's dispute resolution and Citizen Petition processes. Moreover, he has developed significant litigation experience against FDA, including successfully obtaining preliminary and permanent injunctive relief in drug and device cases. He also routinely conducts internal investigations regarding compliance with FDA legal and regulatory requirements.

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 Prescription Drug User Fee Act (PDUFA IV) with FDA; enacting the Food and Drug Administration Amendments Act of 2007, and revising the PhRMA Code on Interactions with Healthcare Professionals.

matters

• Prepared comments on behalf of a pharmaceutical client objecting to a Citizen Petition requesting the FDA to mandate safety labeling changes to the client's approved prescription drug
• Conducted an internal investigation on behalf of a pharmaceutical company regarding compliance with newly-enacted state and federal laws regarding the disclosure of clinical trial information
• After submitting a Citizen Petition, filed a successful lawsuit against FDA in which we obtained a permanent injunction requiring pending Abbreviated New Drug Applications (ANDAs) to submit patent certifications to a newly-listed patent, resulting in a superseding 30-month stay of approval
• Participated as the legal representative on the Promotional Review Committees of several small, medium and large pharmaceutical companies for, among other things, antiviral, cardiovascular, anticoagulant, and imaging drugs
• Represented the underwriter in an Initial Public Offering for a biopharmaceutical company seeking funding to continue development of its investigational drugs and to submit its first New Drug Application to the FDA
• Testified before Congress on behalf of a medical device manufacturer distributing an over-the-counter (OTC) drugs-of-abuse test kit to concerned parents
• Prepared comments to FDA on behalf of a trade association regarding FDA's ongoing Transparency Initiative
• Served as an expert witness on FDA regulatory issues in a patent infringement case and a case involving the Prescription Drug Marketing Act and related state laws
• Assisted a medical device company in obtaining 510(k) clearance for a dental software device
• Filed a lawsuit against FDA successfully challenging a Not Substantially Equivalent (NSE) determination regarding a medical device. As part of the settlement, FDA agreed to rescind the NSE order, grant 510(k) clearance, and withdraw a previously-issued Warning Letter

recognition

Best Lawyers in America, Administrative Law (2010-2012)

Who's Who Legal: The International Who's Who of Life Sciences Lawyers (2008)

PhRMA Board of Directors Exceptional Service Award (2007)

news and insights

Mr. Lassman is scheduled to give a presentation entitled "Hatch-Waxman and BPCIA Overview" at the American Conference Institute's upcoming FDA Boot Camp.  The FDA Boot Camp conference will take place on September 22nd and 23rd in Boston, Massachusetts.  Mr. Lassman's presentation is scheduled for September 22, 2011. 

On August 31, 2011, Mr. Lassman conducted a webinar on the Food and Drug Administration's Bad Ad Program.  The event was sponsored by Thompson Media Group.

Mr. Lassman moderated a panel on "Regulatory Strategies and Conundrums" at the Food and Drug Law Institute's conference on "Brands, Generics, and Hatch-Waxman: New Challenges, Unabated Controversy" on June 24, 2011.

publications

Thomas O. Henteleff, Kinsey S. Reagan, Scott M. Lassman, et al., Medical Devices Law and Regulation Answer Book 2011-2012.  Practising Law Institute 2011.