Craig is an experienced health care executive, having served as corporate vice president and general counsel for Novo Nordisk, and senior vice president, general counsel and secretary for Daiichi Sankyo. As a practicing corporate and health care lawyer for more than 30 years, he advises clients on legal, compliance, policy and regulatory matters relating to health care products and businesses along the full spectrum—from discovery through commercialization. Well versed in the processes and the inner workings of the Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), he advises on clinical studies, inspections and recalls, drug safety programs and negotiates product labeling with the FDA. He advises clients on promotional and medical communications under FDA regulations, guidance and enforcement practices, and First Amendment litigation precedent, including print ads, direct-to-consumer television ads, websites and applications. 

Craig analyzes marketing, sales and medical strategies under the health care fraud and abuse laws and the False Claims Act, including with patient assistance programs, grants, continuing medical education (CME), co-pay coupon programs and pricing strategies. He negotiates contracts between product manufacturers and physicians, health systems, payors, pharmacy benefit managers (PBMs), specialty drug distributors, wholesalers and group purchasing organizations (GPOs). Craig also conducts Fair Market Value and Bona Fide Service Fee analyses.

Craig has years of experience with critical health care compliance issues and counsels clients on relevant Department of Justice (DOJ) and Department of Health & Human Services (HHS) Office of Inspector General (OIG) guidance, enforcement practices and industry codes of conduct to craft compliance charters, policies, board and executive fiduciary training, employee role-based training, the creation of effective monitoring and auditing programs and instituting a Recovery and Monitoring Program (RAMP). He conducts internal compliance investigations, counsels clients on remedial measures, and is experienced in handing external government investigations. He also advises clients on federal and state “Sunshine” spend/transfer of value reporting, and on compliance with varying local and state price transparency reporting and other compliance requirements.

Additionally, he has considerable experience negotiating technology and product licenses; strategic alliances; co-development and commercialization agreements; and acquisitions and divestitures of products, assets, facilities and corporate entities and the associated due diligence process.

A leader in the health care industry, Craig formerly served as a chair of the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Law Section Executive Committee and as a chair and board member of the Healthcare Institute of New Jersey (HINJ). He is also the recipient of multiple awards for his leadership of in-house legal departments and is a regular author of articles on health care issues and speaker at industry-wide events.