Neal Di Spirito
Neal Di Spirito

Neil P. DiSpirito

Of Counsel

dispiriton@ballardspahr.com
Tel 215.864.8386
Fax 215.854.8999
Philadelphia
Tel 202.661.7609
Fax 202.661.2299
Washington, DC

Neil P. DiSpirito has more than two decades' experience helping pharmaceutical, medical device, and life sciences clients comply with U.S. and international drug, biologic, and medical product regulation.

His practice focuses on providing regulatory and enforcement counsel to companies of all sizes on products regulated by the U.S. Food and Drug Administration (FDA.) He has litigated against the FDA and negotiated with its Office of General Counsel. He also handles licensing, patent and labeling issues, managed care issues, FDA enforcement defense and state enforcement matters, civil seizure claims, consent decrees, Medicare and Medicaid issues, and federal supply issues.

Before becoming an attorney, Mr. DiSpirito 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 through the product life cycle. He also teaches pharmaceutical law at the Food and Drug Law Institute (FDLI) and to the FDA’s newly hired attorneys and reviewers.

Mr. DiSpirito is a member of Ballard Spahr’s Business and Finance Department and its Life Sciences and Technology and Health Care Groups.

Professional Activities

Food and Drug Law Institute, speaker and member

Florida Medical Device Manufacturers Consortium, Chair, Regulatory Committee and speaker

American Bar Association, speaker and member

Florida Bar Association

Federal Bar Association

FDA Bar Association

Seminole County Bar Association

Orange County Bar Association

Recognition & Accomplishments

Florida Super Lawyers Rising Stars, 2013-2015

Speaking Engagements

Mr. DiSpirito teaches pharmaceutical law at the Food and Drug Law Institute (FDLI) and to the FDA’s newly hired attorneys and reviewers.

"FDA Center Director Update: Center for Biologics Evaluation and Research (CBER)," Food and Drug Law Institute Annual Conference, Washington, D.C., May 4, 2017

"Effect of the 21st Century Cures Act," Ballard Spahr webinar, March 23, 2017

"Higher Education and the Changing Administration," Ballard Spahr webinar, February 23, 2017

"Managing Regulatory Changes in the Health Care Industry," Ballard Spahr webinar, December 12, 2016

"Nutraceuticals - Regulatory Trends and Intellectual Property Opportunities," Ballard Spahr PATENTSCAPE® webinar, October 19, 2016

"Clinical Laboratories – The Future of Governmental Regulation and Enforcement," Ballard Spahr webinar, May 26, 2016

Publications

Co-editor-in-chief and author, Bringing Your Pharmaceutical Drug to Market, Food and Drug Law Institute Press, 2015

Co-author, "Can FDA Accelerate Clinical Trial Timelines and Completion Using Documented cGMP Processes?" Food and Drug Law Institute's Food and Drug Policy Forum, October 2013

Co-author, "How to Comply with cGMPs," an FDLI primer, May 2013

Co-author, "The Regulatory Ordeal of the Craft Distiller: Legal Processes and Considerations in Labeling Distilled Spirits, first published on the American Distilling Institute website (www.distilling.com), May 2013





Barry University, Dwayne O. Andreas School of Law (J.D.)

Fairleigh Dickinson University (MBA, magna cum laude)

St. Joseph's University (B.S.)

Florida

U.S. Court of Appeals for the 11th Circuit

U.S. District Court for the Middle District of Florida

U.S. Court of Appeals for the District of Columbia

Not licensed to practice in Pennsylvania or the District of Columbia