Key Experience

  • Advises clients in the health care sector in food and drug law, in particular compliance with U.S. Food and Drug Administration (FDA) regulations and federal and state fraud and abuse laws.

Practice

Marlee Gallant is a counsel in the health care and life sciences practice. She focuses on food and drug law and health care compliance, reimbursement and regulatory matters. Marlee represents hospitals and health systems, major academic medical centers, pharmaceutical and medical device manufacturers and a variety of other health care entities. 

Representative Work

  • Advising on the FDA submission process for a next-generation sequencing test and CMS coverage and coding strategy for an academic medical center.
  • Assisting in an advocacy effort before Congress and federal agencies to obtain Medicare coverage for comprehensive genomic profiling tests.
  • Counseling a pharmaceutical company regarding the implications of Medicare payment policies and state laws affecting patient access to pharmaceutical products, including laws and policies relating to biosimilars, the 340B program and continuity of care.
  • Advising numerous early-stage digital-health companies on FDA regulatory strategy and engagement.
  • Developing legal training materials on FDA rules on promotion and communication for products both pre- and post-commercialization, and advising clients on promotional activities and communications for both “consumer” technologies positioned as not FDA-regulated and marketed, cleared or approved medical devices.

Speeches