Kyle Y. Faget is a special counsel and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams.
Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.
Pharmaceutical, Medical Device, and Healthcare Compliance and Counseling :
Kyle has been counseling clients on health care regulatory and compliance issues for more than a decade both as an in-house and a private practice attorney. Her practice includes assisting companies to structure, develop, and implement corporate compliance programs suitable for pre-commercial stage and commercial stage pharmaceutical and medical device companies, including drafting core compliance policies and advising on Sunshine Act reporting obligations.
She also works with companies to assess compliance risks associated with sales and marketing efforts. In this capacity, Kyle counsels clients on False Claims Act, Civil Monetary Penalties, including beneficiary inducement, and Anti-Kickback Statute issues.
Kyle conducts internal investigations and provides clients with strategic and tactical advice regarding government investigations. She has also assisted companies operating under Corporate Integrity Agreements and Deferred Prosecution Agreements and has managed Independent Review Organizations.
Kyle earned her law degree from the University of Michigan Law School (J.D. 2007), where she served as executive editor, Michigan Journal of Law Reform; and executive symposium editor, Michigan Telecommunications and Technology Law Review. She also received the Book Award, FDA Law (awarded to the top student in the FDA Law class). She holds a certificate in post-baccalaureate pre-medical studies from Bryn Mawr College (2002), and an A.B. in physiological psychology, with a minor in neuroscience, from Smith College (1997).
Kyle is admitted to practice in Massachusetts.
Professional Memberships, Pro Bono, and Community Involvement :
Kyle is a member of the American Health Lawyers Association, and her pro bono work includes advising telemedicine clients regarding state laws impacting physician practices. Kyle currently serves as the Chair of the Board of Directors of Fenway Health, a Federally Qualified Community Health Center.
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