Gary Rom goes beyond rule-based counsel to help health care clients develop creative, compliant solutions to launch and promote drugs and medical devices and their corresponding support programs.
An agile advisor and former legal associate for Eli Lilly and Company, Gary is intimately aware of the interplay between how products are marketed and how that marketing impacts competitor complaints, consumer protection actions and product liability. He partners with clients to help them understand that balance and navigate it aptly, accounting for business objectives and regulatory parameters.
Gary’s areas of expertise include:
- Food, Drug and Cosmetic Act (FD&C Act)
- Industry Codes and Guidelines (e.g., AdvaMed Code of Ethics, PhRMA Code on Interactions with Health Care Professionals)
- Lanham Act
- Anti-Kickback Statute (AKS)
- Patient support programs and hubs
- Copay/savings card programs
- PhRMA Code
- FDAMA Section 114 and communications to payers
- Office of Inspector General (OIG) Advisory Opinions
- Drug pricing
- Product vouchers and samples
- Appeals support
Gary has experience reviewing upfront discount agreements and direct to purchase agreements with specialty pharmacies, value based contracts, group purchasing organization (GPO) agreements, wholesaler agreements, confidential disclosure agreements, and master service agreements.
He also has a penchant for evaluating and improving internal processes due to his extensive experience working with cross-functional teams.
