David C. Gibbons
J.D., Health Law Concentration, Seton Hall University School of Law
M.P.H., University of Rochester School of Medicine and Dentistry
B.A., University of Rochester College of Arts & Sciences
District of Columbia
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David Gibbons brings significant industry experience to his legal practice in which he provides counsel to pharmaceutical and biotechnology companies on regulatory strategy and compliance, product development, life cycle management, and corporate transactional matters.
Prior to joining the firm in 2014, Mr. Gibbons practiced in the health care and life sciences practice of a Washington, D.C. law firm. There, he advised pharmaceutical and medical device companies regarding regulatory compliance, assisted clients undergoing government investigations, and served as regulatory counsel for private equity firms and health care companies engaged in mergers and acquisitions, joint ventures, and other strategic business affiliations.
Prior to beginning his legal career, Mr. Gibbons spent 20 years in the development of pharmaceutical and biologic products. He began his career at University of Rochester Medical Center, working on NIH-funded HIV/AIDS therapeutic and vaccine research. He later held increasingly-responsible roles within Research & Development at GlaxoSmithKline, one of the world's largest pharmaceutical companies where his responsibilities ranged from spear-heading post-marketing responses to FDA, co-authoring regulatory submissions to FDA and EMA, leading product development teams, to developing product-specific international development and commercialization strategies for pipeline products.
Prescription Drugs and Biologics
• Advises on matters involving late stage FDA product development, pre-clinical and clinical development plans, including all phases of clinical trials, and FDA submission strategies.
• Advises on strategies for interacting with FDA before and during the IND/NDA/BLA process, Advisory Committee meetings, and other ad hoc meetings with FDA.
Advertising and Promotion
• Advises clients on requirements pertaining to labeling and advertising claims in print and electronic media.
• Counsels clients on compliance with federal and state health care fraud and abuse laws.
• Advises clients on compliance with federal and state transparency reporting requirements connected with financial arrangements among manufacturers and health care providers.
• Works with companies on compliance with federal and state data privacy and security laws in the conduct of their clinical research, marketing, patient assistance, and other programs.
• Serves as FDA regulatory counsel on corporate transactional matters and conducts regulatory due diligence involving pharmaceutical and biotechnology companies or products.
American Bar Association
American Health Lawyers Association
David C. Gibbons et al., Regulation of Advertising and Promotion of Drugs, Medical Devices and Biologics, in THE FUNDAMENTALS OF LIFE SCI. LAW: DRUGS, DEVICES, AND BIOTECH (Am. Health Lawyers Ass'n et al. eds., 2d ed. 2014).
George B. Breen & David C. Gibbons, Understanding the Value of Your Chief Compliance Officer, PHARM. COMPLIANCE MONITOR (May 8, 2013).
Articles / Publications
• Amarin Case Tests Limits of FDA Regulation of Off-Label Promotion,
October 1, 2015
• Summary of HRSA 340B Proposed Guidance,
September 3, 2015
see more blog entries
• 2017: A Banner Year for State Laws on Drug Pricing, Price Reporting, and Discounting,
November 2, 2017
• California Enacts Law to Increase Drug Pricing Transparency,
October 13, 2017
• CMS Abandons Pilot Program to Test Alternative Drug Payment Models Under Medicare Part B,
October 11, 2017
• HHS Will Delay 340B Final Rule Implementation to July 2018,
October 2, 2017
• PhRMA and BIO Team Up Again to Challenge a State Drug Pricing Law,
September 7, 2017