NEIL P. DI SPIRITO is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, and the St. Petersburg offices of Epstein Becker Green. He has more than two decades of experience helping pharmaceutical, medical device, biologic, and life sciences clients comply with U.S. and international drug, biologic, and medical product regulation.
Mr. Di Spirito:
- Provides regulatory and enforcement counsel to companies of all sizes on products regulated by the U.S. Food and Drug Administration (FDA)
- Advises clients on preparing new drug, biologic license, pre-market approval, and 510(k) applications
- Counsels clients on legal issues relating to the design and implementation of clinical trials
- Negotiates manufacturing, supply, and quality assurance agreements
- Advises on various aspects of the cannabis industry
- Conducts FDA regulatory reviews of product labeling and promotional materials
- Conducts FDA regulatory due diligence assessments as part of mergers, acquisitions, and other business transactions
- Assists clients in the negotiation and drafting of FDA regulatory provisions for business contracts
- Advises clients regarding FDA compliance audits, and conducts internal investigations on behalf of clients
- 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
In addition, Mr. Di Spirito has successfully litigated against the FDA, defending clients on alleged cGMP violations and approval issues. He also has substantial experience negotiating 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 on matters of policy and product approvals.
Before joining Epstein Becker Green, Mr. Di Spirito was a member of the Business and Finance Department, and the Life Sciences and Technology and Health Care Groups, at a national law firm, where he also established and led the firm’s FDA practice. Prior to becoming an attorney, Mr. Di Spirito worked 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.
Mr. Di Spirito 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 FDLI’s 2018 Annual Conference Planning Committee. Mr. Di Spirito is also chair of the Regulatory Committee of the Florida Medical Device Manufacturers Consortium.
In addition, Mr. Di Spirito was named to the Florida Rising Stars list (2013-2018) in the area of Food and Drugs.
- Barry University, Dwayne O. Andreas School of Law (J.D., 2006)
- Fairleigh Dickinson University (M.B.A., magna cum laude, 1997)
- St. Joseph's University (B.S., 1982)
- District of Columbia
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. Court of Appeals for the Eleventh Circuit
- U.S. District Court, Middle District of Florida
- American Bar Association
- FDA Bar Association
- Federal Bar Association
- Florida Bar Association
- Florida Medical Device Manufacturers Consortium, Chair, Regulatory Committee
- Food and Drug Law Institute, Audit Committee
- Orange County Bar Association
- Seminole County Bar Association