Scott Lassman, Partner, Wilmer Cutler Pickering Hale and Dorr, LLP
Mr. Lassman’s practice focuses on strategic counseling and advocacy, with a special emphasis on pharmaceutical lifecycle management and competition issues, advertising and promotion, drug and device labeling, drug and device product approval and FDA regulatory policy.
Prior to joining the firm, Mr. Lassman served 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 developing and advocating industry positions on many of the most controversial issues facing the pharmaceutical industry, including drug safety, direct-to-consumer (DTC) advertising, use of citizen petitions, clinical trial disclosure and implementation of the Hatch-Waxman provisions of the Medicare Modernization Act. Mr. Lassman also provided legal advice to the trade association’s Scientific and Regulatory Affairs department on major regulatory initiatives, including anti-counterfeiting and electronic track and trace technologies, paperless labeling and creation of the Biomarkers Consortium.
Major projects included:
Mr. Lassman also has more than ten years of experience in private practice solving complex FDA legal and regulatory issues for clients. He was a partner at Kleinfeld, Kaplan and Becker (KKB) (1999-2003) where he represented clients in civil and criminal matters regarding the regulation of pharmaceuticals, medical devices, foods, cosmetics, dietary supplements and related medical and consumer products. Significant experience includes achieving regulatory objectives through the use of citizen petitions and other administrative avenues and, when necessary, successfully obtaining preliminary and permanent injunctive relief in drug and device cases against the FDA. Mr. Lassman also testified before a Congressional subcommittee on behalf of a device manufacturer seeking to market OTC drugs-of-abuse test kit to parents.
Mr. Lassman is a member of the Food and Drug Law Institute (FDLI) Drugs and Biologics Committee. Previously, he served on the National Drug Advisory Coalition for the National Associate of Boards of Pharmacy (NABP) and was an Appellate Complaints Officer tasked with hearing complaints regarding violations of the new marketing code adopted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) .
Mr. Lassman is a frequent commentator to the news media on FDA regulatory and policy issues. He has appeared on radio and television programs such as NPR’s Talk of the Nation and CNBC and has been extensively quoted in national newspapers and magazines, including the Washington Post, New York Times, Boston Globe, Forbes and Newsweek. He also frequently writes and speaks on pharmaceutical and medical device issues at programs sponsored by the Food and Drug Law Institute, the American Conference Institute, the Regulatory Affairs Professionals Society and others.