Bringing a diverse set of strategic skills to his practice, Kinsey S. has spent the past four decades representing and advising clients on all aspects of FDA and healthcare law. Kinsey 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).
Kinsey’s pharmaceutical clients also rely on his sound advice and counsel concerning controlled substance regulation and representation in DEA proceedings. He 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. Kinsey recently served as lead counsel on a successful challenge of a CMS Medicaid rebate ruling in a 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.
Kinsey routinely conducts regulatory due diligence for pharmaceutical, device, and food clients in connection with major mergers and acquisitions.
Before 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.