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.
Profile
Experience
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, among others:
- 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 is a member of the Food and Drug Law Journal’s editorial advisory board and previously served on the review committee for the Food and Drug Law Journal’s H. Thomas Austern Writing Competition.
Meryl was recently recognized for her professional excellence by Best Lawyers in their fourth and fifth editions of Best Lawyers: Ones to Watch in America for administrative/regulatory law.
She 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.
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