Neil DiSpirito, Partner, Brown Rudnick
Neil DiSpirito is an FDA law partner in the Firm’s Corporate and Global Life Sciences Practice Groups.
Clients call Neil when complex government regulations or decisions threaten their company’s future by jeopardizing transactions, mergers, acquisitions, licenses, new product applications, enforcement proceedings, administrative actions, litigation, stalled applications or civil and criminal investigations and complaints.
Neil’s practice focuses on a wide array of regulatory and compliance issues in the pharmaceutical, biologic, supplement, and medical device industries (and related data privacy and security regulatory issues). Neil also advises on many business transactions and filings for FDA regulated products and companies.
For over two decades, Neil has helped his clients navigate complex government regulations or decisions that impact their future. He has advised all types of life sciences companies on a broad range of U.S. and international regulatory compliance challenges and issues that arise in government regulatory approvals and actions, transactions, mergers, acquisitions, licensing, products liability litigation and other disputes.
Neil has successfully litigated and negotiated against the Food and Drug Administration (FDA), defending clients on alleged cGMP violations, marketing, and approval issues. He also has substantial experience negotiating on matters of policy and product approvals with the FDA’s Office of Chief Counsel and with the Regulatory, Compliance, and Review departments within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.
Prior to joining Brown Rudnick, Neil was a partner at Epstein Becker Green and at Ballard Spahr, where he was a member of the Life Sciences and Technology and Health Care Groups, and established Ballard’s FDA practice. Prior to becoming an attorney, Neil worked as an executive for major pharmaceutical manufacturers in the U.S., EU, Asia Pacific and Latin America in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval, and worldwide business development. He also negotiated with regulatory authorities to launch products and manage them throughout the product life cycle.
Neil teaches pharmaceutical, biologic, and medical device law at the Food and Drug Law Institute (FDLI) and to FDA’s newly hired attorneys, reviewers, and compliance officers. He serves on FDLI’s Audit Committee and was co-chair of its 2018 Annual Conference Planning Committee. Neil has also served as Chair of the Regulatory Committee of the Florida Medical Device Manufacturers Consortium.