Michael Labson

Michael S. Labson

Partner

mlabson@cov.com
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Covington & Burling LLP
One CityCenter
850 Tenth Street, NW
Washington, DC 20001-4956
Tel: +1 202 662 5220

   

Practices

Education

  • Harvard Law School, J.D., 1994
    • magna cum laude
    • Harvard Law Review, Officer and Treasurer
  • Harvard University, A.B., 1989
    • magna cum laude

Judicial Clerkship

  • Hon. David M. Ebel, U.S. Court of Appeals, Tenth Circuit, 1994-1995

Bar Admissions

  • Colorado
  • District of Columbia

Michael Labson’s practice spans the full range of pharmaceutical, biologics and medical device regulation.  He provides strategic advice in dealing with the FDA and other agencies.  He has litigated a variety of cases in the life sciences area, and works actively on transactional and legislative matters.

Mr. Labson’s recent work has involved issues such as clinical trial conduct; breakthrough therapy designation and accelerated approval; FDA dispute resolution; orphan drug, pediatric and Hatch-Waxman market exclusivities; product promotion; REMS; pharmacovigilance; drug samples; GMP and quality system requirements; FOIA; and Rx/OTC switches.  He also has expertise on DEA and controlled substances issues, and child-resistant packaging requirements.

Mr. Labson is a member of the firm’s Management Committee, and previously was one of the firm’s Hiring Partners and co-chair of the Diversity Committee.  He is also actively involved in pro bono work.

Representative Matters

  • Lead counsel for Genentech in landmark hearing on FDA’s withdrawal of the metastatic breast cancer indication for Avastin® .
  • Regulatory counsel to international biopharmaceutical company in novel FTC investigation related to generic drug bioequivalence standards.
  • Successfully advised emerging biopharmaceutical company on obtaining orphan drug exclusivity following initial FDA denials of designation.
  • Led regulatory diligence for $250M acquisition of late-stage oncology company and $600M acquisition of cancer immunology firm.
  • Led internal investigation of scientific publications actitivies for top global pharmaceutical company.
  • Represented Merck 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.

Previous Experience

  • PriceWaterhouse Strategic Consulting Group, Staff Consultant (1989-1991)

Honors and Rankings

  • Fellow of the American Bar Association
  • The Best Lawyers in America (2010-2015)
  • 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).

Pro Bono

  • 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

Publications and Speeches

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