Beaton, Nathan A.

Nathan A. Beaton

Partner

nathan.beaton@lw.com
    Beaton, Nathan A.

    Nathan A. Beaton

    Partner

    nathan.beaton@lw.com

    Profile

    Nate Beaton advises clients on regulatory, transactional, litigation, and legislative matters involving the US Food and Drug Administration (FDA) and other regulatory authorities with jurisdiction over healthcare and biotechnology.

    Nate leverages his broad understanding of the regulatory landscape and sophisticated industry knowledge to serve as a trusted advisor for:

    • Pharmaceutical, biological product, human cellular and tissue product, and medical device manufacturers
    • Digital health companies
    • Clinical laboratories and in vitro diagnostics manufacturers
    • Contract development and manufacturing organizations
    • Food, dietary supplement, cosmetic, cannabidiol, and tobacco product manufacturers
    • Trade associations
    • Investors and lenders with interests in the healthcare and life sciences industry

    He guides clients on complex regulatory issues, as well as legislation and rulemaking. Nate has been involved extensively in Administrative Procedure Act (APA) litigation, challenging and defending FDA actions and regulatory programs.

    Nate helps clients evaluate regulatory risks and opportunities in the context of transactions in the healthcare and life sciences sectors.

    A recognized thought leader, Nate frequently speaks and writes on healthcare and life sciences topics. He serves on the Food and Drug Law Journal’s editorial review board.

    Thought Leadership

    Nate’s recent publications and speaking engagements include:

    • “Has the FDA Meaningfully Changed Its Restrictions on Off-Label Communications?,” Connected with Latham (December 2023)
    • “FDA to Address Proposed Rule to Subject Laboratory-Developed Tests to Agency Oversight in Public Webinar,” Latham Client Alert (October 2023)
    • “Shooting for the Moon: The Evolution of Key AI/ML Regulations Governing Certain Healthcare Products and Services,” Health Law Connections (August 2023)
    • “FDA Publishes Proposed Rule for Tobacco Product Manufacturing Practice Requirements,” Latham Client Alert (April 2023)
    • “FDA Omnibus Reform Act: Examining the Policy Changes,” Latham Client Alert (January 2023)
    • “Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities,” Latham Client Alert (December 2022)
    • “Continuing Appropriations Act Includes FDA Reauthorization of User Fees,” Latham Client Alert (October 2022)
    • "Regulation of Biological Product Marketing,” Food and Drug Law Institute (October 2022)
    • “The New Drug Approval Process,” Food and Drug Law Institute (April 2022)
    • "Healthcare & Life Sciences: Who Is the New FDA Commissioner and What Are His Priorities?,” Connected with Latham (February 2022)

    Experience

    Regulatory

    Nate regularly counsels at all stages of the product life cycle, including on:

    • Pre-market regulatory interactions and product submissions
    • Clinical trials and pre-clinical testing
    • Non-patent exclusivity
    • Good manufacturing practice
    • Promotion and labeling
    • Inspections and recalls
    • Post-market regulatory interactions and appeals
    • Enforcement actions

    Transactional

    Nate’s recent transactional experience includes representing:

    • Momenta Pharmaceuticals in its US$6.5 billion acquisition by Johnson & Johnson
    • The Carlyle Group and Ortho Clinical Diagnostics, a UK-organized, Nasdaq-listed global leader in in vitro diagnostics, in Ortho’s merger with Quidel, valuing Ortho at approximately US$6 billion
    • Nordic Capital in its investment in Equashield, an Israeli-based, leading global provider of closed-system transfer devices
    • Goldman Sachs in Lyell Immunopharma’s US$425 million initial public offering (IPO)
    • Sight Sciences in its US$240 million IPO
    • Revolution Medicines in its US$300 million and US$230 million public offerings

    Litigation and Investigations

    Nate’s recent litigation and investigations experience includes representing:

    • Fontem in litigation concerning a denial of its marketing application, in which the US Court of Appeals for the District of Columbia Circuit vacated the denial as unlawful under the Federal Food, Drug, and Cosmetic Act and arbitrary and capricious under the APA
    • Catalyst Pharmaceuticals in litigation concerning approval of a competitor’s drug due to Catalyst’s orphan drug exclusivity, in which the US Court of Appeals for the Eleventh Circuit reversed the district court and directed judgment in Catalyst’s favor
    • Genus Lifesciences in litigation regarding an FDA patent certification, in which the US District Court for the District of Columbia concluded that the FDA erred during its approval of a competitor’s product and granted partial summary judgment in favor of Genus
    • An international tobacco company in connection with a review of whistleblower allegations regarding the compliance of its marketing practices with FDA requirements
    • A pharmaceutical company in an internal investigation of alleged misconduct by a principal investigator during a clinical trial

    Qualifications

    Bar Qualification

    • District of Columbia
    • Maryland

    Education

    • JD, University of Chicago Law School
      With Honors
    • MPP, University of Chicago
    • BA, Tufts University

    Practices

    Industries

    Recognition

    News & Insights

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