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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 Drug Promotion Policies. Testified for Pharmaceutical Research and Manufacturers of America (PhRMA) at FDA Part 15 public hearing on "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products."
  • FDA Avastin® Approval. Lead counsel for Genentech in landmark hearing on FDA’s withdrawal of the metastatic breast cancer indication for Avastin® (bevacizumab).
  • Payor Communications/Healthcare Economic Information. Developed compliance policy on the communication of healthcare economic information and conducted company-wide training for Global 500 pharmaceutical company.
  • Big Data/Real World Evidence. Advise health technology and data analytics company on regulatory issues for the collection, development, and use of real world evidence on the use of medicines.
  • MiraLAX® Rx-OTC Switch. Represented Merck and Bayer on FDA withdrawal of approval of misbranded Rx generic versions of MiraLAX® following the successful OTC switch of the product.
  • Orphan Exclusivity Appeal. Successfully advised emerging biopharmaceutical company on obtaining orphan drug exclusivity following initial FDA denials of designation.
  • SDNY Investigation. Regulatory counsel for pharmaceutical company in novel False Claims Act investigation of pharmacovigilance practices by the U.S. Attorney’s Office for the Southern District of New York (SDNY).

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 (formerly)
  • Children’s Law Center, 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 (2010-2019)
  • Chambers USA - America's Leading Business Lawyers (2008-2018) ("very well connected with what is going on with the FDA" and "very available, approachable and he grasps what it is that you are dealing with rapidly")   
  • Washington DC Super Lawyers, FDA (2012-2018)
  • LMG Life Sciences, Attorney of the Year - Regulatory (2016); “Life Science Star” (Regulatory) (2012-2017)  
  • Who's Who Legal, Life Sciences (2015-2018)