Jeremy Lutsky

Counsel, Manatt Health

Jeremy Lutsky has over 20 years of deep FDA regulatory, transactional and in-house compliance experience, including ten-plus years working in-house with several prominent biotech and medical device companies. With an intimate understanding of the needs and inner workings of the pharmaceutical and medical device spaces, he provides counsel on a wide range of legal and regulatory matters, including FDA compliance, contracting, transactions, M&A, advertising, sponsorships and promotional review.

Before joining Manatt, Jeremy served as senior legal and compliance counsel for a leading biopharmaceutical manufacturing company, where he was the primary legal contact for all regulatory and compliance matters related to the company’s antibiotic product and co-promoted respiratory product. He worked with internal teams across sales, marketing, finance and HR to advise on commercial and regulatory issues ranging from advertising and promotions, fraud and abuse laws, pricing and reimbursement, contracting and HCP advisory boards, and consulting relationships.

As a member of the commercial leadership team, Jeremy provided not only legal and compliance guidance but also input on cutting-edge initiatives such as patient assistance programs and market access. In addition, he was relied upon to keep the team abreast of new regulatory developments, such as the recent guidance documents on payor communications and medical product communications that are consistent with approved labeling.

Jeremy has deep experience developing and implementing programs that ensure compliance with federal and state laws, including the False Claims Act, the Anti-Kickback Statute, Pharmaceutical Research and Manufacturers of America and Advanced Medical Technology Association codes, the Sunshine Act, and other FDA/Office of Inspector General guidance. He has also led the compliance function for multiple pharma and device companies. Jeremy’s experience includes drafting and rolling out relevant policies and procedures; conducting in-person and online training, auditing and monitoring to ensure compliance; and conducting investigations when necessary.
As a former senior associate for a large national law firm and corporate counsel to a specialty pharmaceutical and wound care company, Jeremy has also represented hospitals, academic medical centers, health plans and other related health systems on a variety of regulatory compliance and transactional matters. Learn More