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Michael S. Labson

Partner

Boston +1 617 603 8808

  • About
  • Representative Matters
  • Credentials
  • About

    Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for over 25 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in litigation, investigations, and transactions.

    Mike is the managing partner of the Boston office and co-chairs the firm's global Life Sciences practice. He previously served in a number of firm leadership positions, including as a member of the firm’s Management Committee and Executive Committee and as co-chair of the Diversity Committee.

    Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on:

    • Clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access.
    • Regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals.
    • FDA dispute resolution.
    • Orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards.
    • Product promotion, payer, and scientific exchange communications.
    • Company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes.
    • Rx-to-OTC drug switches and OTC drug claims.
    • DEA requirements for controlled substances.

    Mike’s pro bono work focuses on criminal justice matters. He is on the Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law, and is a Fellow of the American Bar Foundation.

    Mike is Band 1 in Chambers Global and Chambers USA for Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance. He is also recognized in The Best Lawyers in America, Washington DC Super Lawyers, and LMG Life Sciences, where he was the Life Sciences Attorney of the Year in 2016.

    As one reviewer in Chambers stated, Mike is “a terrific regulatory lawyer and a good business counselor, who can explain things in ways that regular people can understand.”

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • FDA Drug Promotion Policies & First Amendment. 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).
    • CBD/DEA. Obtained successful opinion from U.S. Drug Enforcement Administration on legal status of synthetic CBD.
      M&A. Led FDA and health care regulatory due diligence on multi-billion dollar M&A transaction.

    Areas of Expertise

  • Credentials
    Education
    • Harvard Law School, J.D., 1994
        • magna cum laude
        • Harvard Law Review, Officer and Treasurer
    • Harvard University, A.B., 1989
        • magna cum laude
    Bar Admissions
    • Massachusetts
    • District of Columbia
    • Colorado
    Judicial Clerkship
    • Hon. David M. Ebel, U.S. Court of Appeals, Tenth Circuit, 1994 - 1995
    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.
    Accolades
    • Fellow of the American Bar Association
    • Chambers USA - America's Leading Business Lawyers: Band 1, Nationwide Life Sciences: Regulatory/Compliance (2019-2023) & District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory (2005-2023) ("extremely responsive, very smart, and very calm" and "His approach to matters, coupled with deep experience, has proven invaluable.")
    • Chambers Global, Life Sciences: Regulatory/Compliance (2020-2023), Band 1 ("He's a remarkable talent in the FDA regulatory and enforcement arena.").
    • LMG Life Sciences, “Life Science Star”/Leading Life Sciences Lawyer (2012-2022/23); Attorney of the Year – Regulatory (2016)
    • The Best Lawyers in America (2010-2022); FDA Law Lawyer of the Year (2022)
    • Who's Who Legal, Life Sciences - Regulatory (2015-2023)
    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   
    • Food and Drug Law Institute
    Previous Experience
    • PriceWaterhouse Strategic Consulting Group, Staff Consultant (1989-1991)

    Areas of Expertise

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