Susan S. Lee is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office. She focuses her practice on representing pharmaceutical, biotechnology and medical products manufacturers on issues involving federal laws such as the Food, Drug, and Cosmetic Act, the Public Health Service Act; as well as applicable international and state laws and regulations.
Prior to joining McDermott, Susan was an associate at an international law firm where she advised clients in the medical products and health care sectors on a range of regulatory and legislative matters. She also was a consultant at McKinsey & Company, where she advised health care manufacturers and providers – both in the United States and abroad – on strategic and operational business issues. In addition, Susan has health care policy experience, particularly with respect to coverage and quality issues.
Representative Experience
- Wrote key filings and procedural letters for an FDA administrative proceeding regarding the agency’s proposal to withdraw accelerated approval of an indication for a biological product.
- Developed key negotiating parameters for and negotiated clinical trial agreements for the pivotal clinical trial of an oncology product, including agreements with clinical trial sites outside the United States.
- Advised and represented multiple pharmaceutical companies in qui tam investigations regarding FDA-related allegations.
- Drafted final report for senior executives that summarized the findings and recommendations of a panel of outside experts regarding the safety and pharmacovigilance systems of a major pharmaceutical company.
- Reviewed comprehensive sets of print and online promotional materials for multiple products of a global pharmaceutical company.
- Conducted regulatory due diligence of a biotech company’s early-stage product pipeline.
- Developed arguments and responses to a Congressional inquiry about private investor ownership in the long-term care industry.
Education
- Harvard Law School, J.D.
- Harvard University, A.B. (summa cum laude)
