Nathan Beaton advises healthcare and life sciences companies and their investors and lenders on matters involving the Food and Drug Administration (FDA) and other regulatory authorities with jurisdiction over healthcare and biotechnology.

Mr. Beaton’s practice spans regulatory, transactional, litigation, and legislative matters involving FDA-regulated industries. He helps clients, from emerging companies to market leaders, navigate the most complex aspects of FDA regulation and oversight. Mr. Beaton also advises on legislation and rulemaking and has been involved extensively in Administrative Procedure Act (APA) litigation, challenging and defending FDA actions and regulatory programs. 

Mr. Beaton leverages his regulatory expertise and industry knowledge to advise clients on transactions in the healthcare and life sciences sectors. He helps clients to evaluate regulatory risks and opportunities in the context of a range of transactions, including:

  • Mergers and acquisitions
  • Capital markets offerings and public company matters
  • Strategic transactions
  • Public and private financings
  • Loan transactions and debt facilities

A recognized thought leader, Mr. Beaton frequently speaks and writes on healthcare and life sciences topics. He is a member of the Food and Drug Law Journal’s editorial advisory board.

He also maintains an active pro bono practice and previously served on the firm’s Pro Bono Committee.

Thought Leadership

Mr. Beaton’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)
  • “Origins and Overview of FDA and the Regulation of Drugs,” Food and Drug Law Institute (November 2021) 
  • “Regenerative Medicine and Advanced Therapies,” Food and Drug Law Institute (October 2021)
  • “The TCA and the Deeming Regulation,” Food and Drug Law Institute (November 2020)
  • “Overview of Drug Law and Regulation,” Food and Drug Law Institute (November 2020)
  • "Regulation of Tobacco and Nicotine Products” in A Practical Guide to FDA’s Food and Drug Law and Regulation (7th ed.) (September 2020)
  • “FDA’s Regulatory Processes,” Food and Drug Law Institute (August 2020)

Mr. Beaton’s representative healthcare and life sciences clients include:

  • 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

Regulatory

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

  • 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

Transactional

Mr. Beaton’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 connection with Lyell Immunopharma’s US$425 million initial public offering
  • Sight Sciences in its US$240 million initial public offering
  • Revolution Medicines in its US$300 million and US$230 million public offerings

Litigation

His recent litigation 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 FDA erred during its approval of a competitor’s product, and granted partial summary judgment in favor of Genus

Bar Qualification

  • District of Columbia
  • Maryland

Education

  • JD, University of Chicago Law School, 2016
    With Honors
  • MPP, University of Chicago, 2016
  • BA, Tufts University, 2012