Craig B. Bleifer Partner

He has extensive knowledge of the processes and operations of the Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). Craig advises on clinical trials, inspections, recalls, drug safety programs, and product labeling. He also guides pharmaceutical and medical device clients on promotional and medical communications in accordance with FDA regulations and guidance, enforcement practices, and litigation precedents, including print ads, direct-to-consumer TV ads, websites, and apps.

Additionally, Craig evaluates marketing, sales, and medical strategies in light of fraud and abuse laws, the Anti-Kickback Statute and the False Claims Act, focusing on patient assistance programs, grants, continuing medical education (CME), co-pay coupon programs, and pricing and rebate 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). He also conducts Fair Market Value and Bona Fide Service Fee analyses.

Compliance is at the core of Craig’s practice, based on his years of practical experience in mission-critical compliance issues, and in creating and implementing compliance programs. He advises clients on pertinent guidance from the Department of Justice (DOJ) and the Department of Health & Human Services (HHS) Office of Inspector General (OIG). He develops compliance charters, policies, board and executive fiduciary training, employee role-based training, effective monitoring and auditing programs, and implements a Recovery and Monitoring Program (RAMP). Craig conducts compliance program assessments, internal compliance investigations, advises on remedial measures, and is skilled in managing external governmental investigations. He also provides counsel on federal and state “Sunshine” spend/transfer of value reporting, as well as compliance with various local and state price transparency regulations and requirements.

Moreover, Craig has significant experience in negotiating technology and product licenses, forming strategic alliances, co-development and commercialization agreements, and managing acquisitions and divestitures of products, assets, facilities, and corporate entities.  Craig leads the due diligence process for investments and acquisitions of life sciences companies by lenders, private equity, venture capital, and other stakeholders in the sector. He also provides these clients with strategic advice on proposed targets and product lines, based on his deep knowledge of business operations and the applicable law and regulations which may provide obstacles as well as opportunities for growth.

As a leader in the life sciences industry, Craig previously chaired the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Law Section Executive Committee and served as chair and board member of the Healthcare Institute of New Jersey (HINJ). He has received multiple awards for his leadership in in-house legal departments and regularly writes articles on healthcare topics and speaks at industry-wide events.