Barrett J. Tenbarge

FDA-Regulated Products

Barrett advises clients on a wide array of matters involving FDA-regulated products, especially matters that require holistic strategies aligned across legal, regulatory and public policy domains. He focuses on guiding biopharmaceutical and medical device companies, as well as trade associations, research institutions, retailers, investors and others on matters related to:

• Product development milestones and strategy
• Clinical trials, including relationships with clinical trial sites, contract research organizations, institutional review boards and ethics committees, and other organizations
• Regulatory submissions, including those related to special designations, and regulatory exclusivity strategies
• Post-market requirements, including marketing and promotion and quality issues
• Agency inspections, recalls, warning letters and other enforcement-related actions
• Agency, congressional, and internal investigations related to compliance with FDA and related requirements
• Diligence related to a variety of public and private transactions, including mergers and acquisitions, joint ventures, and securities offerings
• Contracts and commercial disputes with a regulatory nexus

Barrett also advises food, dietary supplement, and cosmetic companies and trade associations on FDA regulatory questions, including regulatory submissions, compliance, enforcement and policy matters.

Health Care and Life Sciences Regulatory Matters

Barrett advises clients on health care and life sciences matters with a nexus with the FDA framework and biomedical research. This includes health care regulatory and reimbursement, antitrust, and requirements enforced by the Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), National Institutes of Health (NIH), U.S. Department of Agriculture (USDA) and other agencies.

Public Policy Matters

Barrett leverages his government experience to advise clients on matters related to public policy, the legislative process, and executive and congressional oversight. This includes responding to congressional investigations and oversight, preparing for hearings, and creating strategies for working with Congress and other stakeholders to achieve public policy goals.

Teaching

At the George Mason Scalia School of Law, Barrett is an adjunct professor, teaching FDA Law and Policy.

Prior Experience

Barrett served as general counsel at the Senate Health, Education, Labor, and Pensions (HELP) Committee under Chair Bill Cassidy. In addition to his work on FDA matters, he acted as the principal staffer responsible for committee process, rules, precedent and ethics, and advised on policy, legal and oversight matters across the entire HELP Committee jurisdiction. This included spearheading the response to the Supreme Court’s Loper Bright decision. Prior to this role he served as senior health counsel at the HELP Committee under the ranking member, Richard Burr.

At the HELP Committee, Barrett was involved in negotiating and drafting multiple pieces of legislation that became or are on track to become law, including the Food and Drug Omnibus Reform Act (FDORA), the PREVENT Pandemics Act, the Modernizing Cosmetics Regulation Act (MOCRA), and reauthorizations of the over-the-counter (OTC) and animal drug user fee programs. Barrett has been involved in major health care legislative initiatives, multiple high-profile hearings on drug pricing and the COVID-19 pandemic response, two FDA commissioner confirmations, and drafting a committee white paper on artificial intelligence. He also worked with FDA and stakeholders as Congress assessed potential reforms to the regulation of tobacco, diagnostics, controlled substances and cannabis, among other areas.

Prior to working on Capitol Hill, Barrett worked at an international law firm in Washington, D.C.

Personal Interests

Barrett’s personal interests include American political and business history, rooting for his favorite sports teams (namely, all Indiana pro teams, the Indiana Hoosiers, the Nashville Predators and the St. Louis Cardinals), and spending time with his wife and young daughter.