Consumer Genetic Testing: Are There Sustainable Business Models and at What Risks?
Business Model Panel Discussion – Consumer Genetic Testing
10:50 AM - 11:35 AM
Kyle Faget is of counsel and a 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, Ms. Faget held in-house positions at pre-commercial and commercial stage companies.
Pharmaceutical, Medical Device, and Healthcare Compliance and Counseling
Ms. Faget 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, Ms. Faget counsels clients on False Claims Act, Civil Monetary Penalties, including beneficiary inducement, and Anti-Kickback Statute issues. Ms. Faget 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.
Ms. Faget regularly advises pharmaceutical and medical device clients regarding advertising and promotion issues, including off-label promotion. She regularly assesses marketing materials directed toward healthcare providers and direct-to-consumer advertising campaigns for compliance with the Food, Drug, & Cosmetic Act and FDA Guidance documents. Ms. Faget helps clients navigate through the new drug and device approval process.
Clinical Research, Clinical Trials, and Life Sciences
Ms. Faget has extensive experience drafting and negotiating agreements with and for Contract/Clinical Research Organizations and Site Management Organizations. She regularly drafts and negotiates Clinical Trial Agreements, Informed Consents, and other clinical development agreement on behalf of pharmaceutical and medical device clients. Additionally, Ms. Faget has drafted and negotiated a broad swath of operational agreements for her pharmaceutical and medical device clients, including Contract Manufacturing Agreements, Distribution Agreements, Master Services Agreements, and Material Transfer Agreements.
Telemedicine, Telehealth, and Digital Health
Ms. Faget advises suppliers, physician practices, consultants and vendors, and a variety of other health care entities on a range of business, legal and regulatory issues affecting the telemedicine industry. She handles matters involving contracting fraud and abuse compliance, Medicare and Medicaid reimbursement, self-disclosures and overpayments, the Anti-Kickback Statute, physician self-referrals (the Stark Law), health care marketing rules, HIPAA, corporate compliance programs, contracting, confidentiality and information sharing, and policies and procedures.
Ms. Faget is a member of the American Health Lawyers Association, and her pro bono work includes advising telemedicine clients regarding state laws impacting physician practices. She currently serves as the Chair of the Board of Directors of Fenway Health, a Federally Qualified Community Health Center.
Ms. Faget earned her law degree from the University of Michigan Law School in 2007 (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. Additionally, she holds a certificate in post-baccalaureate pre-medical studies from Bryn Mawr College and an A.B. in physiological psychology, with a minor in neuroscience, from Smith College.