Kinsey S. (“K.S.”) Reagan has been a partner at KKB since 1985. His practice is focused on advising and representing FDA-regulated companies on virtually all aspects of FDA and health care law.
Mr. Reagan has substantial experience in the areas of pharmaceutical regulation (e.g., drug and biologic marketing approval and enforcement policies, drug and biologic advertising and promotion, product life cycle and exclusivity, clinical trials, HIPAA), and medical device regulation (e.g., combination products, premarket clearance, Quality System requirements, in vitro diagnostics medical device recalls). Mr. Reagan regularly advises pharmaceutical clients on controlled substance regulation and represents clients in DEA proceedings. He also has a specialty in veterinary drug regulation, assisting companies seeking FDA or USDA approval of animal drugs and biologics and advising veterinary drug manufacturers on product labeling and promotion. Mr. Reagan advises food and agricultural companies on compliance with FDA and USDA requirements, including food safety, organic labeling, Good Manufacturing Practices, and Good Agricultural Practices. He frequently conducts regulatory due diligence for pharmaceutical, device, and food clients in connection with major mergers and acquisitions.
Mr. Reagan regularly advises and represents pharmaceutical and device clients on health care reimbursement matters. He assists clients in obtaining favorable coverage, coding and payment terms under health care reimbursement programs, particularly Medicare and Medicaid. He frequently advises clients on compliance with fraud and abuse laws, including the federal antikickback statute and analogous state laws. Mr. Reagan helps clients to evaluate product discount and rebate contracts, consulting agreements, grants, and other disbursements and to draft contracts with PBMs, GPOs, HMOs, and other managed care organizations, as well as direct purchasers, with a view toward achievement of commercial objectives consistent with legal requirements. Mr. Reagan also regularly advises on pricing and price reporting matters arising from the Medicaid drug rebate program, the 340B program, Medicare Parts B and D, and the Federal Supply Schedule, as well as reporting issues under Physician Payments Sunshine Act.
Prior to joining KKB in 1981, Mr. Reagan started his legal career in the Office of the General Counsel, U.S. Department of Health and Human Services, where he specialized in public health issues, privacy law, freedom of information, and health care reimbursement.
Best Lawyers in America, FDA Law, 2016-2019
Martindale-Hubbell rated AV-Preeminent
Mr. Reagan presented on Animal Drug Advertising and Promotion – Opportunities and Pitfalls in the Regulatory Maze at the American Conference Institute’s inaugural Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics, September 10-11, 2015, New York City.
“Clinical Investigations: Investigational Device Exemption, Institutional Review Boards, and Informed Consent,” Food & Drug Law Institute, Introduction to U.S. Medical Device Law and Regulation, April 12, 2018, Washington, DC.
“Other Agencies and Considerations,” Food & Drug Law Institute, Introduction to Advertising & Promotion for the Drug, Medical Device, and Veterinary Medicine Industries, September 25, 2017, Washington, DC.
“The New Drug Approval Process: NDA Submission and Review”, Food & Drug Law Institute, Introduction to U.S. Drug Law and Regulation, April 26, 2017, Washington, DC.
“Quality System Regulation (QSR),” Food and Drug Law Institute, Introduction to Medical Device Law and Regulation: The Legal Framework for Medical Device Regulation, November 3, 2016, Washington, DC.
“New Considerations for Advertising and Promotion of Animal Drugs and Animal Foods,” American Conference Institute, Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food, September 15, 2016, New York City, NY.
“Navigating the Regulatory Maze of Advertising and Promotion in the Animal Medicines Industry,” American Conference Institute, The Legal, Regulatory and Compliance Forum on Animal Health and Veterinary Drugs and Therapeutics, September 11, 2015, New York City, NY.
“Enforcement & Compliance,” Food & Drug Law Institute, Introduction to Medical Device Law and Regulation, May 7, 2014, Washington, DC.
“Device Modifications Under a 510(k),” Regulatory Affairs Professional Society (Chicago Chapter), April 24, 2013.
“Antibiotics in Food,” American Conference Institute, October 4, 2012, Chicago, IL.
Thomas O. Henteleff, Kinsey S. Reagan, Scott M. Lassman, et al., Medical Devices Law and Regulation Answer Book 2011-2012. Practising Law Institute 2011.
“Drug Advertising and Promotion, Violations and Enforcement, Import/Export Requirements, and International Issues,” Introduction to Drug Law and Regulation, Food & Drug Law Institute/Center for Drug Evaluation and Research In-House Training, May 20, 2008, Silver Spring, MD.
“Conducting a Due Diligence Review of a Drug or Device Manufacturer,” Life Sciences Law Institute, American Health Lawyers Association, May 1-3, 2006, Baltimore, MD.
“Managed Care Contracts – Seeking the Safe Harbors,” Inaugural Pharmaceutical Marketing Compliance Congress, January 27, 2004, Washington, DC.
Moderator, “Hot Topics” from FDA’s Center Directors: Center for Food Safety and Applied Nutrition (CFSAN) and Food Safety and Inspection Service (FSIS), Food & Drug Law Institute 45th Annual Educational Conference, April 17, 2002, Washington, DC.
Moderator, “Hatch-Waxman Patent and Exclusivity Controversies: Impact on the Pharmaceutical Market,” Food & Drug Law Institute 43d Annual Educational Conference, December 17, 1999, Washington, DC.
“Exploring Liability Issues in Labeling,” Pharmaceutical Labeling Conference, Barnett Parexel, March 25, 1999, Arlington, VA.
Introduction to Drug Law, Food & Drug Law Institute, February 1996, Washington, DC.
Basic Food Law Workshop, Food & Drug Law Institute, February 1988, Washington, DC.
Basic Food Law Workshop, Food & Drug Law Institute, October 1983, Washington, DC.