Marlee P. Gallant is an associate in the health care and life sciences practice. She focuses on food and drug law and health care compliance, reimbursement and regulatory matters.
Practice & Background
Ms. Gallant represents hospitals and health systems, major academic medical centers, pharmaceutical and medical device manufacturers, and a variety of other health care entities.
Her work includes advising health care clients on compliance with federal and state fraud and abuse laws, including the federal antikickback statute, the Stark Law and the False Claims Act. In addition, she counsels clients on regulatory and legislative developments on a wide range of issues, including Medicare reimbursement law and policy.
Ms. Gallant also counsels pharmaceutical, biotechnology, and medical device and technology companies with regard to government regulation and public policy initiatives, focused primarily on regulatory and reimbursement strategies and compliance with laws implemented by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Her work includes advising such clients on U.S. and international laws and regulations related to the development and commercialization of pharmaceutical products, medical devices and other health technologies, including access to care, fraud and abuse, FDA labeling and promotional matters, human subject protection and privacy.
Ms. Gallant provides advice related to clinical trials, including negotiating clinical trial agreements, both with parties in the United States and internationally; assessing compliance issues; structuring trials from FDA and CMS perspectives; and providing guidance on FDA and Office of Human Research Protections requirements. She spent time on a secondment with a leading academic medical center, where she negotiated clinical trial agreements and supported technology development.
Ms. Gallant received her J.D. in May 2014 from Loyola University Chicago School of Law, where she was managing editor of the Loyola University Chicago Law Journal. Ms. Gallant was awarded a fellowship by Loyola’s Beazley Institute for Health Law and Policy and earned a Certificate in Health Law. She was also a fellow of the Loyola Institute for Consumer Antitrust Studies.
During law school, Ms. Gallant was a judicial intern for a magistrate judge in the U.S. District Court for the Northern District of Illinois and a legal intern at the American Medical Association, headquartered in Chicago, Illinois. Ms. Gallant was a member of Akin Gump Strauss Hauer & Feld LLP’s 2013 summer associate class.
- 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
- performing due diligence analysis in connection with a hospital system acquisition for compliance with federal and state fraud and abuse provisions, privacy laws, and other statutory and regulatory restrictions
- counseling an academic medical center with respect to the compliance risks associated with a joint venture affiliation involving analysis of federal and state fraud and abuse laws, state corporate practice of medicine, fee-splitting and certificate-of-need laws, and requirements associated with the 340B program
- negotiating sophisticated clinical trial agreements and other agreements relating to technology development on behalf of pharmaceutical companies, medical device manufacturers and academic medical centers
- engaging FDA on development of cybersecurity standards on behalf of a medical device cybersecurity company
- advising a health technology company on the application of FDA device regulations to its products
- advising a biomedical company on FDA classification of a combination product
- producing global, U.S. and U.K. compliance handbooks for a pharmaceutical company based in India
- advising a dialysis company on Medicare and Medicaid regulatory issues impacting its business
- engaging stakeholders (patients and physicians) to educate FDA and federal policy-makers on issues relating to osteoarthritis.
- panelist, “Understanding and Applying Ethics and Confidentiality Rules in the MLP Context,” webinar hosted by the National Center for Medical-Legal Partnerships (July 9, 2015).