Scott M. Lassman

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Office: (202) 248-5426

Scott Lassman has nearly 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice.  He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them.  His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters.

Scott helps life sciences companies navigate the FDA approval process, including using the formal and informal dispute resolution mechanisms to address stalled development programs.  He also helps companies take advantage of the complex exclusivity and patent certification rules that apply to drug and biologic applications, preparing and submitting detailed advocacy letters and Citizen Petitions to FDA when necessary. Scott also has extensive experience litigating FDA disputes in federal court. He has successfully protected his clients’ interests through litigation in a wide variety of matters, including 180-day exclusivity, pediatric exclusivity, user fees, and approval requirements.

In addition, Scott has extensive policy experience, previously serving as the head FDA regulatory attorney at a major pharmaceutical trade association during negotiation and passage of landmark drug legislation.  His work now includes drafting and analyzing proposed legislation, preparing white papers and talking points, and analyzing and responding to FDA’s proposed regulations and draft guidance documents for life sciences companies and trade associations.

Before starting Lassman Law+Policy, Scott was the Chair of the FDA Practice Group at a leading, international law firm, a partner at a well-regarded FDA boutique, and the head FDA regulatory attorney at a major pharmaceutical trade association.  Scott enjoys working in a boutique environment and founded Lassman Law+Policy so that he could devote more time to his clients.

When not practicing law, Scott is an avid amateur photographer, tennis player, and chef (although his wife claims he is lost without his recipes).

Education

  • Harvard Business School, Strategic Negotiations Course
  • J.D., University of Virginia School of Law, Order of the Coif
  • M.A., University of Texas at Austin, University Fellowship
  • B.A., Yale University, cum laude

Recognition

  • LMG Life Sciences
    - FDA Regulatory Attorney of the Year (Pharmaceuticals), Shortlist, 2017, 2018
    - Life Sciences Star, 2016 - 2018
  • Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory (DC), 2017 - 2019
  •  Best Lawyers in America, Administrative and Regulatory Law; FDA Law, 2010 - 2020
  • Who's Who Legal: The International Who's Who of Life Sciences Lawyers, 2008, 2014 - 2019
  • The Legal 500, Healthcare: Life Sciences, 2017
  • Super Lawyers, FDA Law, 2013 - 2017

Admitted to Practice

  • District of Columbia
  • Maryland

Professional Affiliations

  • Food and Drug Law Institute
  • Regulatory Affairs Professionals Society
  • American Bar Association

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