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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.
Education:
Rensselaer Polytechnic Institute, B.S. cum laude, 1972
Harvard Law School, J.D. cum laude, 1975
Professional Affiliations:
Member of the District of Columbia Bar
Member of the Massachusetts Bar
American Bar Association
Federal Bar Association
American Health Lawyers Association
Practice Credentials:
U.S. District Court for the District of Columbia
U.S. Court of Appeals for the District of Columbia Circuit
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