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 and assists in assessing risk in transactional matters.
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.
Investigations and Litigation
- Represented multiple global medical device manufacturers in parallel FCA and FDCA investigations into allegations related to reporting failures, manufacturing practice concerns, and consumer deception, leading to DOJ declinations.
- Led multiple internal compliance investigations into allegations related to device quality concerns and potential misrepresentations to regulators.
- Represented an individual and university in connection with a criminal investigation related to research fraud and use of an unapproved device.
- Represented an individual in a criminal prosecution alleging conspiracy to defraud FDA in connection with drug manufacturing issues.
- Represented pharmaceutical client in federal legal challenge to an FDA clinical hold imposed on a Phase II clinical trial.
- Represented an international pharmaceutical distributor in a criminal investigation into potential violations of the FDCA and state laws governing wholesale distribution of prescription drugs.
- Represented individual in FCA investigation related to regulation of HCT/Ps.
- Led an internal compliance investigation for a U.S. pharmaceutical client in connection with manufacturing and data integrity issues at foreign facility.
- Led internal investigation into alleged cGMP and QSR violations in connection with manufacturing of combination product.
- Prepared client for questioning by FDA in connection with device investigation that lacked an investigational device exemption.
- Represented multiple global device manufacturers in assessments of potential enforcement risk associated with device nonconformities. Also counseled clients through disclosures to FDA and recall strategies.
- Counseled medical device manufacturer through recall negotiations with FDA that resulted in a labeling correction rather than a product removal.
- Represented and counseled client through self-report of compliance issues impacting multiple product categories and implementation of remediation plan.
- Counseled multiple clients through emergency use authorization process for decontamination systems for personal protective equipment and for diagnostic tests in connection with COVID-19 pandemic.
- Advised client in connection with device importation.
- Regularly advise clients on responses to FDA Form 483 observations, sampling controls, and advertising and promotional issues.
- Advised client in connection with potential regulatory challenge and litigation options in connection with agency denial of certain labeling claims.
- Counseled pharmaceutical manufacturer regarding potential civil and criminal exposure associated with data integrity issues in preclinical research.
- Counseled rare disease drug manufacturer in connection with offering compassionate use access to an investigational drug.
- Counseled pharmaceutical client in connection with outreach to FDA on question about compliance with unclear regulation.
- Counseled client regarding OTC monograph compliance in connection with hand sanitizer.
- Advise clients on DEA inspection readiness and loss investigation and reporting.
- Advise clients on use of controlled substances in research.
Food and Cosmetics
- Advised cosmetics company regarding FDA labeling requirements in connection with defense in state and federal consumer class action.
- Advise food and cosmetics companies in connection with potential recall scenarios.