Michael S. Labson

Partner

mlabson@cov.com
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Covington & Burling LLP
1201 Pennsylvania Avenue, NW
Washington, DC 20004-2401
Tel: 202.662.5220


 

Practices

Industries

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

  • District of Columbia
  • Colorado


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 (2008-2014) (“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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