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Michael H. Hinckle

Fax +1.919.516.2115
Fax +1.202.778.9100
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. 

Professional Background

Prior to entering private practice, Mr. Hinckle worked as a molecular biologist with the American Type Culture Collection. He then represented various FDA-regulated companies in private practice for 7 years before becoming the Vice President and General Counsel for Synthon Pharmaceuticals, Inc., a position that he held for 5 years. Mr. Hinckle is a frequent lecturer and author on FDA and pharmaceutical industry matters.

Professional/Civic Activities

  • Food and Drug Law Institute
  • North Carolina Regulatory Affairs Forum

Speaking Engagements

  • Biosimilars--The Current Legal Landscape,” North Carolina Biotechnology Center, February, 2016
  • "FDA Regulation of Generic Drugs and Biosimilars,” North Carolina Regulatory Affairs Forum, RAC Certification Course Lecturer, July 2016
  • “Surviving an FDA Inspection,” North Carolina Biotechnology Center, CLE, January, 2015
  • "FDA Regulation of Medical Textiles,” Guest Lecturer, North Carolina State University, October, 2014
  • “The Biosimilars Act—A Basic Introduction,” NC CED Biotech Forum, September 2010
  • "Analysis of the Commonwealth Brands and Teva Pharmaceuticals Cases,” Food and Drug Law Institute 2010 Annual Meeting, April 2010
  • "New Product Development," Campbell University School of Pharmacy, annual lectures on FDA regulatory matters, 2006-2009
  • "Preparing for Paragraph IV Challenges - Generic Pre-suit Strategies," CBI, Paragraph IV Conference, October 2008
  • "Interpreting Forfeiture Provisions - An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy," CBI, Paragraph IV Conference, October 2008
  • "Protecting the Pharmaceutical Asset," RTP Biotech Day, October 2007
  • "Generic Drugs - Patents and Market Exclusivity," Campbell University School of Pharmacy," April 2006
  • "Basic FDA Regulatory Law," Campbell University School of Pharmacy, January 2006

Additional Information

  • “Amgen v. Sandoz” FDLI Top Cases of 2015, Annual Meeting Materials, April 2016
  • Chapter in “Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014,” FDLI, April 2014
  • “Commonwealth Brands, Inc. et al. v. United States, et al.,” Top 20 Food and Drug Cases, 2009 & Cases to Watch 2010, FDLI (2009).
  • “FDA Tobacco Regulation: The Dog That Caught the Bus?” Update, FDLI, November/December 2009.
  • “The Right Tool for the Job: Closing Hatch-Waxman Act Loopholes Requires Legislative Reform,” Update, FDLI, March/April 2003.
  • “Section 11 of the Best Pharmaceuticals for Children Act – A Prelude to Reform,” Update, FDLI, March/April 2002.
  • Advised providers and suppliers on pharmaceutical managed care, Medicare Part D, and Group Purchasing Organization agreements.
  • Advised providers and suppliers on pharmaceutical government pricing issues related to commercial and government contracts.
  • Successfully petitioned CMS for a “narrow exception” allowing on behalf of a large pharmaceutical company for one of their drugs to be subject to a reduced Medicaid rebate.
  • Provided counseling to specialty pharmaceutical company on numerous FDA regulatory, fraud/abuse compliance, and pharmaceutical pricing matters including: performing regulatory due diligence on proposed marketing arrangements and acquisitions, advising on VA and Medicaid Drug Rebate pricing issues, FDA regulated clinical trial matters, group purchasing organizational contracting issues, and country of origin labelling.
  • Represented a pharmaceutical company in numerous regulatory matters including assistance with New Drug Application (NDA) submissions, counseling concerning clinical trial informed consent issues, licensing agreements concerning combination (drug/device) products, and FDA recall issues.
  • Represented a personal care products manufacturer on responding to FDA inspectional observations and conducting cosmetic and drug product recalls. Worked with the company’s internal quality professionals and external consultant to develop a plan for corrective and preventative actions in response to the FDA inspection.