Kyle Faget

Experience

Kyle Faget is a Boston-based partner and a health care and life sciences lawyer with Foley & Lardner LLP. Kyle is the Co-Chair of the firm’s Health Care Practice Group, and Co-Chair of the Health Care & Life Sciences Sector’s Medical Device and Equipment Area of Focus.

Kyle advises investors, academic medical centers, physician practices, and consultants on a range of business, legal and regulatory issues affecting the telemedicine industry. She helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act (FDCA), the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.

Kyle works with start-up and established entrepreneurs to create direct-to-consumer medical services using synchronous and asynchronous telemedicine offerings. She advises on strategic models for care delivery and revenue streams, state-by-state telemedicine modalities and practice standards, contracting with laboratories and pharmacies, and e-commerce issues. Kyle also assists digital health innovators understand and navigate the FDA regulatory landscape.

Kyle has married her years of experience counseling pharmaceutical and medical device companies on their brick-and-mortar clinical trial programs with her telehealth practice to offer cutting-edge decentralized clinical trial advice.

Clinical Research, Clinical Trials and Life Sciences

Kyle has extensive experience drafting and negotiating agreements with and for contract research organizations and site management organizations. She regularly drafts and negotiates clinical trial agreements, informed consents and other clinical development agreements on behalf of institutions and pharmaceutical and medical device clients. Kyle also advises clients on how to leverage and operationalize decentralized clinical trials.

Kyle has also drafted and negotiated a broad swath of operational agreements for her pharmaceutical and medical device clients, including manufacturing agreements, distribution agreements, master services agreements and material transfer agreements.

FDA Regulatory

Kyle regularly advises telehealth, 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 and Cosmetic Act and FDA Guidance documents. Kyle also helps digital health clients navigate the FDA regulatory process when developing new digital health products.

Corporate Compliance

Kyle has assisted multiple pharmaceutical and medical device clients build and operationalize corporate compliance programs. She has also advised clients on compliance with Corporate Integrity Agreements (CIAs). Her work has included drafting compliance policies and regularly conducting sales force training. Kyle has also assisted a number of life sciences companies enter the U.S. market compliantly.