Mr. Hinckle’s practice focuses on counseling corporations and individuals on all aspects of FDA regulatory and pharmaceutical pricing matters. His primary efforts are in the area of pharmaceutical, biologic, and medical device regulation as well as related corporate transactional activities. His experience includes serving as in-house General Counsel for an international pharmaceutical corporation with responsibilities for all legal activities, regulatory affairs, quality assurance, corporate compliance and litigation oversight. Mr. Hinckle’s experience also includes representing clients before the FDA, DEA, CMS, and various State Boards of Pharmacy. He has supervised the filing of numerous drug, biologic, and device investigational and premarket submissions, Citizen Petitions and other regulatory filings. On the post-marketing side, Mr. Hinckle has represented his clients on FDA compliance matters including Warning Letters and negotiation of Consent Decrees. His government pricing experience includes advising pharmaceutical manufacturers on issues under the Federal Supply Schedule, the Medicaid Drug Rebate Program, the Veterans Health Care Act, and Section 340B of the Public Health Service Act.
Articles in the National Law Review database by Michael H. Hinckle