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Michael Labson
Michael S. Labson
Partner
Washington +1 202 662 5220 mlabson@cov.com Download V-card

Michael Labson provides strategic advice to pharmaceutical and biotechnology clients in dealing with the FDA and other agencies. He has litigated a variety of cases in the life sciences area, and works actively on corporate transactions and government investigations.

Mr. Labson’s recent work has involved issues such as clinical trial misconduct; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; biosimilars; product promotion and scientific exchange; REMS; pharmacovigilance; Rx/OTC switches; and DEA regulation of controlled substances. Drawing on his 20+ years of experience working for the biopharmaceutical sector on a wide array of issues, he provides clients creative and practical solutions to solve their regulatory challenges.

  • FDA Avastin® Hearing. Lead counsel for Genentech in landmark hearing on FDA’s withdrawal of the metastatic breast cancer indication for Avastin® (bevacizumab).
  • FDAMA 114/Healthcare Economic Information Policy. Developed compliance policy on the communication of healthcare economic information and conducted company-wide training for Global 500 pharmaceutical company.
  • FTC Citizen Petition Inquiry. Regulatory counsel to international biopharmaceutical company in novel FTC investigation related to generic drug bioequivalence standards.
  • MiraLAX® Rx-OTC Switch NOOH. Represented Merck and Bayer on FDA Notice of Opportunity for Hearing proposing the withdrawal of misbranded Rx generic versions of MiraLAX® following the successful OTC switch of the product.
  • Internal Compliance Investigation. Led internal investigation into complaints of improper conduct in the preparation of pivotal trial clinical study report and peer-reviewed publication for multinational pharmaceutical company.
  • DEA Exempt Chemical Preparation Appeal. Leading appeal of DEA denial of exemption application for novel in vitro diagnostic assay.
  • Orphan Exclusivity Appeal. Successfully advised emerging biopharmaceutical company on obtaining orphan drug exclusivity following initial FDA denials of designation
  • Regulatory Due Diligence. Led regulatory diligence for $250M acquisition of late-stage oncology company and $600M acquisition of cancer immunology firm.

Pro Bono

  • Morris v. Brandenberg (N.M. Court of App.) (Amici Curiae brief for medical and public health groups in support of right to aid in dying).
  • Illinois v. Davis (Ill. Sup. Ct.) (Amici curiae brief for faith-based groups in challenge to life sentences without parole for youth offenders).
  • In the Matter of Kamouane, Mahamat (Immigration Court asylum hearing).
  • Mississippi v. Cory J. Maye (Mississippi capital case).
  • State v. Rogers (Florida capital case).
  • K.S. parole hearing.

Memberships and Affiliations

  • Adjunct Professor of Law at the American University Washington College of Law
  • Children’s Dental Health Project, Vice Chair, Board of Directors
  • American Bar Association
  • Food and Drug Law Institute

Previous Experience

  • PriceWaterhouse Strategic Consulting Group, Staff Consultant (1989-1991)
  • Fellow of the American Bar Association
  • The Best Lawyers in America (2010-2016)
  • Chambers USA - America's Leading Business Lawyers (2008-2015) (“very well connected with what is going on with the FDA" and "uses his subject matter expertise to advise clients in a very clear and concise way”)
  • Washington DC Super Lawyers, FDA (2012-2014)
  • LMG Life Sciences, “Life Science Star” (2012-2014)
  • Washingtonian, Food & Drug "Top Lawyer" (2013)
  • PLC Life Sciences, Which Lawyer? Highly Recommended for Regulatory (formerly FDA) - "He is one of the best known FDA practitioners from the younger generation of regulatory lawyers. Can advise on the whole spectrum of regulatory issues for both pharmaceutical and biotech clients" (2003-2012).