Marlee P. Gallant

Marlee P. Gallant

Akin, Gump, Strauss, Hauer & Feld, LLP, Counsel

Washington, District of Columbia

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. Her work includes advising health care clients on compliance with federal and state fraud and abuse laws, including the federal anti-kickback 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. Marlee 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. Marlee 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. Marlee 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, Marlee 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.

Experience

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Akin, Gump, Strauss, Hauer & Feld, LLP
Counsel
∼ Present
Firm Prospects attorney tracking launched in 2015/2016. Prior employment history currently unavailable.

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