Marlee is a consultant 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 pharmaceutical and medical device manufacturers, technology companies, laboratories, hospitals and health systems, major academic medical centers, non-profit research foundations and a variety of other health care entities. 

Marlee’s work includes advising such clients on U.S. and international laws and regulations related to the commercialization of and post-marketing compliance for pharmaceutical products, medical devices and other health technologies, including developing U.S. Food and Drug Administration (FDA) regulatory strategies and navigating complex coding, coverage and reimbursement challenges. She counsels pharmaceutical clients on a variety of market access matters, including implications of Medicare payment rules, drug utilization management, biosimilar policies and continuity of care laws and regulations.  

She assists medical device and biotechnology firms in obtaining favorable regulatory treatment, including De Novo clearances and combination product reviews. Marlee also counsels clients regarding FDA and Federal Trade Commission (FTC) advertising and promotion matters, including refining promotional and educational communications and developing compliance policies.

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 Centers for Medicare & Medicaid Services (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. 

She conducts due diligence and provides strategic analysis related to transactions across the health care industry, including acquisitions of entities and products, mergers and joint ventures, and a variety of loan agreements, licensing arrangements and investments. 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.

Marlee was named “One to Watch in America” for Health Care Law in 2023 by Best Lawyers.

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.