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+1 202 637 5910

Michael N. Druckman
Partner, Washington, D.C.
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mike.druckman@hoganlovells.com

Mike Druckman counsels life sciences companies and organizations on Food and Drug Administration (FDA) law and regulation. Examples include matters in which his legal advice and advocacy helped a client
  • bring a blood derivative back to market after a product-wide recall;
  • obtain orphan drug designation for a vaccine;
  • prevail on a PDUFA fee dispute with FDA;
  • craft stem cell legislation and regulations;
  • convince the FDA to change a long-standing policy, increasing incentives for innovative drug combinations; and
  • win two separate formal dispute resolution proceedings, allowing the client to market a new formulation of its drug with a new brand name under a separate New Drug Application (NDA).

Prior to joining Hogan & Hartson (now Hogan Lovells), Mike worked for seven years in the FDA's Office of Chief Counsel (OCC), first as Associate Chief Counsel for Enforcement and then as Associate Chief Counsel for Biologics. He served as co-team leader for the biologics team within OCC and advised the Office of Compliance and Biologics Quality (OCBQ), the Office of Blood Research and Review (OBRR), the Office of Vaccine Research and Review (OVRR), and the Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA's Center for Biologics Evaluation and Research (CBER). Before working at the FDA, Mike was a litigator at a prominent Washington, D.C. law firm for nine years, first as an associate and then as a partner, where he focused on complex commercial litigation. Mike clerked for The Honorable John H. Pratt, United States District Judge for the District of Columbia.

Hogan Lovells Publications
13 June 2014 "FDA Issues New Draft Guidance on Identification of Suspect Products and Notification." Pharmaceutical and Biotechnology Alert, Hogan Lovells

05 February 2014 "D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies." Pharmaceutical and Biotechnology Alert, Hogan Lovells

16 December 2013 "FDA Calls for Nominations of Difficult to Compound Drugs." Pharmaceutical and Biotechnology Alert, Hogan Lovells

19 November 2013 "Drug Compounding Bill to Clarify the FDA's Role, Introduce New Regulatory Limits." Pharmaceutical and Biotechnology Alert, Hogan Lovells

09 July 2012 "President to Sign Food and Drug Administration Safety and Innovation Act: Summary of Certain Key Provisions." Health Alert, Hogan Lovells

Published Works
March 2014 "World Stem Cell Summit: Nurturing a Pioneering Community - the Global View." International Innovation

December 2011 "Human Biologics." Food and Drug Law and Regulation, (2d ed.), Food and Drug Law Institute

12 January 2011 "Should Congress Create Stronger Incentives to Develop Vaccines and other Medical Countermeasures Against Pandemic Influenza and Bioterrorism?" Volume 1, Issue 1, The Food and Drug Law Institute

RELATED EVENTS
01 April 2014
FDA's Regulation of Stem Cells and Regenerative Medicine in Light of Regenerative Sciences

PRACTICES
Food, Drug, Medical Device and Agriculture
Pharmaceutical and Biotechnology
INDUSTRY SECTORS
Life Sciences and Healthcare
AREAS OF FOCUS
  • Drug and Biologic Approvals
  • Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
  • Regenerative Medicine and Stem Cells
  • Blood Products
  • Vaccines
  • Drug Supply Chain Security
  • Pharmacy Compounding
  • Medical Countermeasures/Biodefense
  • Corporate Deal and SEC Filing Support
EDUCATION
J.D., University of Pennsylvania Law School, 1990 A.B., magna cum laude, Harvard College, 1987
AWARDS / RANKINGS
  • FDA Commissioner’s Special Citation, Pandemic Influenza Planning and Preparedness Team, 2007 
  • Secretary’s Award for Distinguished Service, Influenza Vaccine Shortage Response Team, 2004
BAR ADMISSIONS / QUALIFICATIONS District of Columbia