Bartlett, Meryl E.

Meryl E. Bartlett

Associate

meryl.bartlett@lw.com
    Bartlett, Meryl E.

    Meryl E. Bartlett

    Associate

    meryl.bartlett@lw.com

    Ones to Watch in America – Administrative/Regulatory Law

    Best Lawyers 2027

    Profile

    Meryl Bartlett advises companies on regulatory, litigation, and transactional matters involving the Food and Drug Administration (FDA) and other regulatory authorities with jurisdiction over healthcare and biotechnology.

    Meryl counsels pharmaceutical, biotechnology, medical device, digital health, food, dietary supplement, cosmetic, and consumer product companies regarding all aspects of the FDA-regulated product life cycle, including:

    • Pre-market development and testing
    • FDA product submissions
    • Market exclusivity strategies, including orphan drug issues
    • Labeling and post-market safety concerns, including Risk Evaluation and Mitigation Strategy (REMS) programs
    • FDA and Federal Trade Commission (FTC) regulation of product marketing and promotion
    • FDA and Drug Enforcement Administration (DEA) export and import requirements
    • Clinical trial, manufacturing, distribution, and other corporate contracts
    • FDA inspections and recalls
    • Civil and criminal compliance and enforcement

    In the transactional space, Meryl advises investment banks, venture capital firms, private equity firms, and commercial lenders on regulatory diligence and disclosure matters in connection with mergers and acquisitions, equity offerings, financings, and other transactions in the life sciences sector.

    A recognized thought leader, Meryl frequently speaks and writes on healthcare and life sciences topics. She has served as a member of the Food and Drug Law Journal’s editorial advisory board and the review committee for the Food and Drug Law Journal’s H. Thomas Austern Writing Competition.

    Meryl also maintains an active pro bono practice, currently serving as the firm’s liaison to the Legal Counsel for the Elderly and as a member of the Legal Counsel for the Elderly’s Young Lawyer’s Alliance. She also serves on the board for Food Recovery Network.

    Experience

    Meryl’s representative experience involving the FDA and other regulatory authorities with jurisdiction over healthcare and biotechnology includes advising:

    Enforcement

    • A global pharmaceutical and device manufacturer on Warning Letter and 483 response strategy, recalls, and internal investigations into quality systems
    • A pharmaceutical compounding company on successfully resolving enforcement proceedings brought by the FDA and the DOJ regarding manufacturing issues
    • A biotechnology company on a high-stakes FDA regulatory matter involving threatened withdrawal of a pioneer product’s marketing authorization
    • A global infant formula company on successfully resolving enforcement proceedings brought by the USDA regarding compliance with USDA’s National Organics Program

    Regulatory

    • A global drug and device company on engagement with FDA leadership regarding internal investigations and whistleblower complaints 
    • A global consumer products company on legal issues relating to FDA’s OTC drug monograph system and drafting a Citizen Petition for submission to FDA on related compliance issues
    • A global pharmaceutical company on premarket review requirements for drugs, an FDA engagement strategy, enhancing its pharmacovigilance program, clinical trial requirements, and DEA regulation
    • A pharmaceutical company on competitive advertising strategy, including successfully challenging competitor noncompliance
    • A life sciences company on an internal investigation relating to the adequacy of its compliance program
    • Life sciences companies on internal investigations of alleged clinical trial misconduct
    • Pharmaceutical companies on strategic regulatory and litigation issues associated with competing products’ orphan exclusivity
    • Large healthcare providers on scaling DEA and DSCSA compliance programs across sites

    Transactional

    • Apollo on its €3 billion investment in Bayer’s long‑acting reversible contraceptives business
    • Warburg Pincus on its agreement to invest up to US$1 billion in Global Eggs, the largest multinational producer and distributor of table eggs
    • Initial purchasers, agents, and arrangers on a US$1.5 billion refinancing for Petco
    • Mission Produce on its US$430 million acquisition of Calavo Growers
    • Precision Concepts International on its acquisition of Comar
    • Clario on its US$8.875 billion sale to Thermo Fisher Scientific
    • Blackstone on an up to US$500 million strategic financing agreement with MannKind Corporation
    • Omada Health, a virtual between-visit healthcare provider, on its IPO
    • Kate Farms on the acquisition of a majority stake by Danone
    • LENSAR on a definitive merger agreement with Alcon through which Alcon intends to acquire LENSAR
    • Gilead Sciences on its US$3.5 billion senior unsecured notes offering
    • PROCEPT BioRobotics on an approximately US$175 million underwritten public offering of its common stock
    • SLR Capital on Debt restructuring, structured equity investment, corporate governance, and other general corporate matters in connection with the Vapotherm merger and take-private
    • The underwriters on Liquidia Corporation’s approximately US$67.5 million common stock financing
    • Platinum Equity in its acquisition of GSM Outdoors, a leading outdoor and consumer sporting goods company
    • Invetx, a pioneer in protein-based therapeutics for animal health, on its acquisition by Dechra Pharmaceuticals
    • The initial purchasers on Organon’s US$1 billion senior notes offering
    • Stride Consumer Partners on its investment in Serenity Kids’ US$50 million Series B financing

    Speaking Engagements

    Some of Meryl’s recent speaking engagements include:

    • “Origins and Overview of FDA and the Regulation of Drugs” Food and Drug Law Institute (April 2024)
    • “Food Law and Regulation,” Food and Drug Law Institute (September 2023)
    • “Forecasting the Future of Personalized Nutrition: Examining New Market Opportunities and Legal Risks for the Supplement Industry,” American Conference Institute and the Council for Responsible Nutrition (June 2023)
    • “The New Drug Approval Process,” Food and Drug Law Institute (June 2022)
    • “Origins and Overview of FDA and the Regulation of Drugs,” Food and Drug Law Institute (November 2021)

    Qualifications

    Bar Qualification

    • District of Columbia
    • Maryland

    Education

    • JD, Georgetown University Law Center, 2017
    • BA, American University, 2014
      magna cum laude

    Practices

    Industries

    News & Insights

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