Kyle Y. Faget

Special Counsel

Overview

Kyle 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.

FDA Regulatory

Kyle 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. Kyle helps clients navigate through the new drug and device approval process.

Clinical Research, Clinical Trials, and Life Sciences

Kyle 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, Kyle 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

Kyle 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.

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.

Education

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).

Admissions

Kyle is admitted to practice in Massachusetts.

Community Engagement

Kyle serves on the board of directors for Fenway Health as well as GLAD Legal Advocates and Defenders.

Speaking Engagements

  • Speaker, “Digital Health and the FDA: Top 5 Legal Issues to Understand,” American Telemedicine Association, February 13, 2019
  • Speaker, “Legal Issues in Telehealth Technology,” Telehealth Technology Summit, New Orleans, LA, December 12, 2018
  • Speaker, “Up and Coming Technology,” Telehealth Technology Summit, New Orleans, LA, December 13, 2018
  • Speaker, “Telemedicine & Medical Devices: Legal and Regulatory Issues: Tech Vendor Key Issues, FDA Device Regulation and Certification, FDA Software as a Medical Device Regulation vs Clinical Decision Support Rules,” 5th Annual Florida TeleHealth Summit, St. Pete Beach, FL, November 8, 2018
  • Speaker, “Direct-to-Patient Telemedicine Legal and Regulatory Considerations,” NRTRC Regional Telehealth Conference, Salt Lake City, Utah, October 2, 2018
  • Speaker, “Behavioral Health in a Digital World, Trends and Considerations,” Boston Health IT Summit, Boston, MA, August 8, 2018
  • Speaker, “Telemedicine Regulations AHLA Distance Learning,” October 17, 2018
  • Panelist, “Telehealth Panel: Treating Patients Beyond the Physician’s Office,” WEDI’s 2018 National Conference, Washington, D.C., October 15, 2018
  • Speaker, “Direct-to-Patient Telemedicine Legal and Regulatory Considerations,” Northwest Regional Telemedicine Center, Salt Lake City, UT, October 2, 2018
  • Speaker, “Behavioral Health in a Digital World: Trends and Considerations,” Boston Health IT Summit, Boston, MA, August 7, 2018
  • Speaker, “The New Drug Approval Process, as part of FDLI’s Introduction to U.S. Drug Law and Regulation,” San Francisco, CA, July 24, 2018
  • “FDA Regulatory Update: 510(k) Guidance, ACC Quick Hits,” May 1, 2018
  • Speaker, “The New GDPR Regulations: What Clinical Operations Needs to Know,” NE Clinical Operations Executive Breakfast, Cambridge, MA, April 24,2018
  • Speaker, “Reading the Tea Leaves: Recent Trends in Regulatory Enforcement of New England ALFs,” New England Regional Winter Conference and Annual Meeting, Woodstock, VT, January 10, 2018
  • Speaker, “FMV for Clinical Trial Best Practices,” Clinical Trial Legal and Contracting Forum, Philadelphia, PA, December 4, 2017
  • Panelist, “Monitoring Non-Promotional Activities within a Complex Global Organization,” CBI Compliance Congress on Non-Promotional Activities, Philadelphia, PA, July 2017
  • Speaker & Panelist, “Gain an Understanding of the Importance of FMV in Clinical Trials” & “Best Practices for Open Payments Reporting of HCP Spend,” CBI 4th Annual FMV Congress, Philadelphia, PA, March 2017
  • Panelist, “A Conversation About Diversity and Inclusion: The Questions You Wanted to Ask,” Women in Law Empowerment Forum, Boston, MA, November 2016
  • Panelist, “Maintaining Effective Regulatory Compliance throughout the R&D Process,” CBI Compliance Congress for Specialty Products, Boston, MA, September 2016
  • Speaker, “Navigating Compliance and Legal Risks Impacting Distribution and Data Management,” CBI Specialty Product Distribution and Dispensing Optimization, Philadelphia, PA, October 2015
  • Panelist, “The FCPA and Beyond: Navigating Global Compliance Risks and Government Investigations in the New International Economy,” Association of Corporate Counsel, Boston, MA, October 2015
  • Speaker, “Managing HCP Engagements to Avoid Kickback Allegations,” CBI Compliance Congress for Specialty Products, Boston, MA, September 2015

Publications

  • Quoted, “FDA looks to De Novo Pathway Model As it Unveils Updates to Pre-Cert Program,” MobiHealthNews, January 8, 2019
  • “ACA Strike-Down: Salvaging the BPCIA via Severability,” Health Care Law Today, January 2, 2019
  • Quoted, ACA Repeal Wouldn't Stop Transition to Value-Based Payment, Efforts to Lower Drug Spending,” Modern Healthcare, December 19, 2018
  • Quoted, “Proposed Framework Lessens FDA's Regulatory Requirements for Prescription Drug Companion Apps,” MobiHealthNews, November 19, 2018
  • “cGMP Violations Should Not Be Used as a Basis for FCA Actions Absent Fraud,” 38 Seattle U. L. Rev. 37 (2014)
  • “Limits on cGMP Violations under the FCA,” 2 Fraud & Abuse, 1 (2013)
  • “The Misuse of the FCA to Enforce cGMP (Current Good Manufacturing Practice) Violations,” 6 No. 24 International In-House Counsel Journal, 1 (2013)
  • “Why FDCA § 505(u) Should Not Concern Us Greatly,” 15 Michigan Telecommunications and Technology Law Review, 453 (2009)
  • Georgia v. Ashcroft: A New Statistical Model, 13 Georgetown Public Policy Review 45 (2007-08)