Washington, DC (August 16, 2018) – Epstein Becker Green (EBG) is pleased to announce that Neil P. Di Spirito, an attorney with more than two decades of experience advising pharmaceutical, medical device, biologic, and life sciences clients on compliance with U.S. Food and Drug Administration (FDA) regulations, has joined as a Member of the Firm in the Health Care and Life Sciences practice in the District of Columbia and Florida.
Mr. Di Spirito’s practice focuses on providing regulatory and enforcement counsel to companies of all sizes on products regulated by the FDA. He has litigated against the FDA and negotiated with its Office of General Counsel. He also handles licensing, labeling issues, managed care issues, FDA enforcement defense and State of Florida enforcement matters, civil seizure claims, consent decrees, Medicare and Medicaid issues, and federal supply issues.
Earlier in his career, Mr. Di Spirito served as an executive for major pharmaceutical manufacturers 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.
As one of the leading authorities in his practice area, Mr. Di Spirito teaches pharmaceutical, biologic, and medical device law at the Food and Drug Law Institute (FDLI) and to the FDA’s newly hired attorneys, reviewers, and compliance officers. He also serves as co-chair of FDLI’s 2018 Annual Conference Planning Committee and as chair of the Regulatory Committee of the Florida Medical Device Manufacturers Consortium.
“EBG’s FDA team includes a group of knowledgeable attorneys who take a multidisciplinary approach to solve clients’ needs, addressing critical situations that companies face throughout the life cycle of a product,” said George B. Breen, Chair of the firm’s National Health Care and Life Sciences Practice Steering Committee. “Neil’s deep experience and industry leadership are a great fit for our practice, and we are pleased that he is joining us.”
“EBG’s focus on the health care industry since its founding is admirable,” said Di Spirito. “I am pleased to be joining a firm that not only has deep knowledge and experience, but also embraces innovation and collaboration in a way that helps clients advance in a rapidly changing environment,” he added.
About Epstein Becker Green
Epstein Becker & Green, P.C., is a national law firm with a primary focus on health care and life sciences; employment, labor, and workforce management; and litigation and business disputes. Founded in 1973 as an industry-focused firm, Epstein Becker Green has decades of experience serving clients in health care, financial services, retail, hospitality, and technology, among other industries, representing entities from startups to Fortune 100 companies. Operating in locations throughout the United States and supporting domestic and multinational clients, the firm’s attorneys are committed to uncompromising client service and legal excellence. For more information, visit www.ebglaw.com.