Mr. Kinsey S. Reagan

Kinsey S. Reagan, Esq. PartnerKleinfeld, Kaplan & Becker, LLP

Mr. Reagan has been a partner at KKB since 1985.His practice has focused on advising and representing FDA-regulated companies on virtually all aspects of food, drug, and healthcare law.Mr. Reagan's current focus has been on pharmaceutical regulation and enforcement policies.

Kinsey S. Reagan, Partner, Kleinfeld, Kaplan & Becker Moderator:

Kinsey S. Reagan, Esq. PartnerKleinfeld, Kaplan & Becker, LLP

Mr. Reagan has been a partner at KKB since 1985.His practice has focused on advising and representing FDA-regulated companies on virtually all aspects of food, drug, and healthcare law.Mr. Reagan's current focus has been on pharmaceutical regulation and enforcement policies.

Kinsey S. Reagan, Partner, Kleinfeld, Kaplan & BeckerModerator:

Kinsey S. Reagan Partner

Kinsey S. Reagan KKB - Kleinfeld Kaplan&Becker, LLP
...
Kinsey S. Reagan Partner kreagan@kkblaw.com

Kinsey S. ("K.S.") Reagan has been a partner at KKB since 1985. He 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. Since joining KKB in 1981, his practice has concentrated on advising and representing FDA-regulated companies on virtually all aspects of food, drug and health care law.

Mr. Reagan's current areas of focus have been pharmaceutical regulation (e.g., drug marketing approval and enforcement policies, drug manufacturing regulations, drug advertising and promotion), food and beverage labeling and promotion (e.g., marketing rules for enhanced water beverages, alcoholic beverage regulation, direct and indirect food additives) and medical device regulation (e.g., Quality System requirements, medical device recalls, application of HIPAA rules). Mr. Reagan also counsels pharmaceutical clients frequently on product life cycle issues, including patent and non-patent marketing exclusivity and 180-day generic drug exclusivity. He has a specialty in veterinary drug regulation, assisting companies seeking FDA or USDA approval of animal drugs and biologics. He also advises veterinary drug manufacturers on product labeling and promotion.

Mr. Reagan regularly advises and represents pharmaceutical clients on health care reimbursement issues, which have become a substantial part of his practice. He assists clients in obtaining favorable coverage, coding and payment terms under health care reimbursement programs, particularly Medicare and Medicaid. He regularly advises clients on compliance with fraud and abuse laws, including the federal antikickback statute and analogous state laws. Mr. Reagan frequently helps clients to evaluate product discount and rebate contracts, consulting agreements, grants and other disbursements to assure consistency with legal and ethical principles, 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 advises on pricing and price reporting issues arising from the Medicaid drug rebate program and AWP-based reimbursement formulas.

Mr. Reagan has given presentations on food and drug law at numerous conferences and seminars. Examples of topics include "FDA Regulations and What They Really Mean - Dodging the Landmines," "Patient-Focused Marketing in a Managed Care Environment," "Biologics Promotion - Hot Issues and Legislative Changes," and "Introduction to Drug Law". He has also moderated sessions on Hatch-Waxman drug marketing exclusivity and on emerging topics in food regulation at recent FDLI annual educational conferences. Most recently he has taught topics in drug law, including regulation of drug marketing and product liability, at periodic FDLI/CDER In-House Training sessions for FDA personnel.