Over his nearly 30 years of experience as an FDA regulatory attorney, Scott Lassman has strong record of success using both the Citizen Petition process and, when necessary, litigation with FDA under the Administrative Procedure Act (APA) to achieve his clients’ business objectives. The issues that rise to this level most often involve complex exclusivity and patent certification disputes, but Scott also has experience with a wide variety of other issues, including user fees, product jurisdiction, and labeling carve-outs, to name a few.
In addition, Scott sometimes serves as a consulting or testifying expert on FDA regulatory law for other law firms in commercial litigation.
Citizen Petitions
Citizen Petitions have become the subject of significant criticism recently, but they are nothing more than a public process for asking FDA to take – or refrain from taking – virtually any type of regulatory action. As such, they are valuable and…
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APA Litigation
Sometimes, litigation is inevitable. Either it is the last and best option to challenge an incorrect FDA decision, or it is a competitor’s last and best option. In either case, a company may decide it makes sense to bring an APA lawsuit against FDA…
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Expert Opinion
Litigation is an unfortunate fact of life for many life sciences companies as well as those who invest in such companies. Commercial disputes can arise with partners, collaborators, contractors, competitors, investors, and insurers. Oftentimes, such…
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Scott Lassman
Scott Lassman has more than 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...
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