Speaker details

Biography

Beth Weinman is a member of the firm’s life sciences regulatory & compliance practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices, cosmetics and dietary supplements. As a former lawyer with the U.S. Food and Drug Administration, Beth brings valuable perspective to clients who turn to her for representation in government investigations, assistance with internal compliance investigations, FDA enforcement actions, product recalls and other agency engagement strategies. Clients frequently look to Beth for representation when facing government investigations or engaging with FDA on regulatory compliance matters, particularly in connection with alleged manufacturing practice violations or inappropriate marketing. She has extensive experience representing clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, internal compliance investigations, and other enforcement actions before state and federal regulators. In addition, she regularly counsels clients through product recalls and withdrawals, responses to 483s and warning letters, and matters regarding marketing practices, manufacturing practices, data integrity issues and good clinical practices. Beth also represents clients in administrative litigation. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the U.S. Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes (e.g., mail fraud, wire fraud, health care fraud, and conspiracies to defraud) under Title 18. She also worked on numerous parallel and independent FCA investigations involving FDA-regulated drugs and devices, and has significant experience in opioid-related investigations. Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where she represented several pharmaceutical companies in government investigations and securities class-action lawsuits, among other matters.