Clients call Neil when complex government regulations or decisions threaten their company’s future through enforcement actions, stalled applications, administrative actions, litigation, or criminal investigations and complaints.
For over two decades 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 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.
In addition, Neil helps pharmaceutical, biologic, medical device, supplement and all types of life sciences clients comply with and challenge U.S. and international drug, biologic, and medical product regulation.
- Defends against FDA/DOJ enforcement actions, reduces charges, negotiates resolutions, and if necessary, tries cases in administrative, civil, and criminal proceedings.
- Pursues administrative and civil remedy against FDA decisions and actions that hinder a company’s ability to function or appropriately produce, market, or have their products approved.
- Provides regulatory and enforcement counsel to companies of all sizes on products regulated by the FDA
- Advises clients on preparing new drug, biologic license, pre-market approval, and 510(k) applications
- Advises clients regarding FDA compliance audits, warning letter responses, inspections gone awry and 483 responses that would lead to further enforcement actions, 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
- 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
Before joining Epstein Becker Green, Neil was a member of the Life Sciences and Technology and Health Care Groups at a national “big law” firm, where he also established and led the firm’s FDA practice. Prior to becoming an attorney, Neil 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.
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 their 2018 Annual Conference Planning Committee. Neil has also served as chair of the Regulatory Committee of the Florida Medical Device Manufacturers Consortium.
In addition, Neil was named to the Florida Super Lawyers’ Florida Rising Stars list 5 years in a row (2013-2018) in the area of Food and Drugs.