Nikki Leon counsels a broad range of clients in healthcare and life sciences on regulatory, compliance, enforcement, and legislative matters. Her clients include pharmaceutical and medical device manufacturers, healthcare research organizations, physician practice groups and professional societies, medical technology companies, clinical laboratories, and makers of conventional food products, cosmetics, over-the-counter drugs, and dietary supplements.

Ms. Leon's regulatory practice focuses on state and federal legislative initiatives affecting the healthcare and pharmaceutical industries; healthcare fraud and abuse regulation (including "Stark" physician self-referral laws and the healthcare Anti-Kickback Statute) and enforcement; and coverage, coding, and reimbursement issues. As part of her practice, she represents clients in criminal and civil investigations, internal investigations, and compliance audits. Her transactional practice focuses on the regulatory, structuring, and business aspects of healthcare business transactions, including compliance considerations for promotional activities, clinical research, educational grants, and charitable giving.


  • Major pharmaceutical and medical device manufacturers—advise on regulatory and compliance considerations in structuring charitable donation agreements and educational grants.
  • Enterprise software company—counsel on contracting considerations in agreements to provide cloud-based services for Medicare Advantage Plans.
  • Leading prosthetics manufacturer—advise on state and federal policy developments, including advocacy for parity in coverage and reimbursement.
  • Biopharmaceutical company—assist in compliance audit of managed markets activities and patient support programs.
  • Physician practice group—represent group practice in government investigation relating to coding and reimbursement.


Pharmacy Point-of-Sale Price Concession and PBM Service Fee Safe Harbor Final Rule May Reshape Medicare Part D: What Pharmaceutical Manufacturers Need to Know Now
Guide to the Trump Administration's Drug Importation Final Rule and Guidance
Pharmaceutical Price Reporting: The "ABCs" and "123s" of Compliance
Co-author, (Chapter) Practicing Law Institute’s Pharmaceutical Compliance and Enforcement Answer Book
Questions & Answers Guide to FDA’s Prescription Drug Importation Proposals
New Developments in DTC Television Advertising: Disclosing Prescription Drug List Prices (pdf)
FDLI's Update


  • JD, Stanford Law School, 2016
  • AB, Princeton University, 2011, summa cum laude
  • District of Columbia

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