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Lassman Law+Policy Submits Citizen Petition to FDA Regarding Vasopressin

On February 2, 2021, Lassman Law+Policy submitted a Citizen Petition to the Food and Drug Administration (FDA) on behalf of Amneal Pharmaceuticals LLC. The petition asks FDA to refuse to approve proposed dosing modifications for vasopressin based on patient genotype because they appear to be unnecessary, without adequate scientific support, and potentially unsafe for patients treated for vasodilatory shock. FDA has 180 days to respond to the Citizen Petition.

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Lassman Law+Policy Client Braeburn Prevails in District Court on 3-Year Exclusivity Dispute

Lassman Law+Policy was privileged to represent Braeburn, Inc. (with co-counsel Goodwin) in securing this U.S. District Court ruling overturning an FDA decision on 3-year exclusivity as unreasonable and arbitrary and capricious. The decision, issued on July 22, 2019, orders FDA to reconsider "with deliberate speed" Braeburn's application for approval of an innovative new injectable treatment for opioid use disorder. Read all about it here.

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Scott Lassman

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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...

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