Kinsey S. Reagan | Kleinfeld Kaplan & Becker LLP

Overview

Bringing a diverse set of strategic skills to his practice, Kinsey S. (KS) Reagan has spent the past four decades representing and advising clients on all aspects of FDA and health care law. KS possesses a particularly in-depth knowledge of the issues that surround 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), and medical device regulation (e.g., combination products, premarket clearance, Quality System requirements, in-vitro diagnostics, digital products). KS’s pharmaceutical clients also rely on his sound advice and counsel concerning controlled substance regulation and representation in DEA proceedings.

KS also frequently works with pharmaceutical and device companies in healthcare reimbursement, pricing, and rebate matters. In particular, he advises and represents clients on price and rebate reporting issues 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 the Physician Payments Sunshine Act. KS recently served as lead counsel on a successful challenge of a CMS Medicaid rebate ruling in federal district court. Additionally, he provides counsel to his clients on compliance with fraud and abuse laws, including the federal anti-kickback statute, False Claims Act, and analogous state laws.

His practice also extends to representing clients 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. He serves as a trusted advisor to food and agricultural companies on compliance with FDA and USDA requirements, including direct and indirect food additives, food safety, and food labeling.

KS routinely conducts regulatory due diligence for pharmaceutical, device, and food clients in connection with major mergers and acquisitions.

Prior to joining Kleinfeld, Kaplan & Becker in 1981, KS 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.

Experience

Served as lead counsel for plaintiff in successful federal district court litigation against CMS in a Medicaid Drug Rebate Program matter
Served as legal counsel representative on several promotional review committees for pharmaceutical clients
Conducted internal corporate investigations of compliance matters (e.g., drug promotion, GMPs, clinical trials) for pharmaceutical clients
Advised numerous pharmaceutical, device, and food clients in regulatory due diligence and contract process for major acquisitions
Assisted pharmaceutical clients in developing corporate policies for price reporting under the Medicaid, Medicare and other health care programs
Assisted pharmaceutical clients in developing SOPs for corporate compliance programs under federal and state laws
Conducted in-house compliance training for employees of a pharmaceutical manufacturer
Prepared responses to competitive trade complaints that supported clients in maintaining the desired promotional message consistent with law and regulations
Represented a medical device manufacturer in meeting with the FDA Office of Combination Products to determine regulatory status of new product
Served as lead counsel representing a pharmaceutical manufacturer in a DEA administrative hearing to control a prescription drug

Publications & Speaking Engagements

“Navigating the Approval Process for Drugs and Biologics,” American Conference Institute’s 35th FDA Boot Camp, September 23, 2020, Virtual Conference.
“Conduct of Clinical Trials for Drugs and Devices, Protection of Human Subjects,” Food & Drug Law Institute, Introduction to Drug and Device Law and Regulation for Patient Organizations, November 5, 2019, Washington, DC.
“Informed Consent, Institutional Review Boards (IRBs), Protection of Human Subjects,” Food & Drug Law Institute – Center for Devices and Radiological Health In-House Training, October 4, 2019, Silver Spring, MD.
“Informed Consent, Institutional Review Boards (IRBs), Protection of Human Subjects,” Food & Drug Law Institute – Center for Devices and Radiological Health In-House Training, June 14, 2019, Silver Spring, MD.
“Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and Informed Consent,” Food & Drug Law Institute, Introduction to Medical Device Law and Regulation, April 11, 2019, Washington, DC.
“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 45^th 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.