Beth P. Weinman
Counsel
Beth Weinman is a member of the firm’s life sciences and FDA regulatory practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices 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, and assistance with internal compliance investigations and FDA enforcement actions. Most recently, Beth has been assisting clients with efforts related to the COVID-19 public health emergency. This work has encompassed advising on the latest FDA guidance and emergency use authorizations regarding personal protective equipment and diagnostic tests, the submission of new Emergency Use Authorization requests to FDA, and the analysis of PREP Act liability questions. She also counsels on the development of new medical technologies, including 3D printing of devices, as well as the implications of CARES Act provisions directly relevant to FDA-regulated life sciences companies.
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.
Experience
Investigations
- 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.
- Represented a U.S. medical products client in connection with multiple federal parallel criminal and civil investigations involving alleged cGMP and QSR violations .
- Prepared client for questioning by FDA in connection with device investigation that lacked an investigational device exemption.
- Counseled medical device manufacturer regarding potential civil and criminal exposure associated with cGMP compliance issues at manufacturing site.
- Counseled medical device manufacturer regarding potential civil and criminal exposure associated with data integrity issues in preclinical research.
Medical Devices
- 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.
Pharmaceuticals
- Regularly counsel clients regarding advertising and promotional issues.
- Represented pharmaceutical client in connection with challenge to an FDA clinical hold imposed on a Phase II trial.
- Advised client in connection with potential regulatory challenge and litigation options in connection with agency denial of certain labeling claims.
- 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.
Publications
- Co-author, “Pandemic May Spur Reform of Lab Test Regulation,” Law360 (April 7, 2020)
- Co-author, “2019 FDA Enforcement Review: Drugs, Biologics, Devices, and Dietary Supplements,” Ropes & Gray FDA Regulatory Alert (February 4, 2020)
- Co-author, “When DOJ Seeks Dismissals Of Life Sciences FCA Cases,” Law360 (December 12, 2019)
- Co-author, “Kisor May Be A New Dawn For Challenges To FDA Actions,” Law360 (December 2, 2019)
- Co-author, “A Guide To FCA Cooperation Credit For Life Sciences Companies,” Law360 (June 18, 2019)
- Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
- Co-author, “2018 FDA Enforcement Review: Drugs, Biologics And Devices,” Law360 (January 28, 2019)
- Profiled, “Fresh From US FDA’s Chief Counsel Office, Beth Weinman Talks Qui Tam and Compliance,” Medtech Insight (November 13, 2018)
- Profiled, “Ropes & Gray Adds Ex-FDA Enforcement Pro In DC,” Law360 (October 26, 2018)
Presentations
- Moderator, “Enforcement Trends,” FDLI Regenerative Medicine Conference (April 2, 2020)
- Speaker, “Violations, Enforcement and International Issues,” FDLI Introduction to Biologics and Biosimilars Law and Regulation (April 1, 2020)
- Speaker, “Outlook 2020,” Ropes & Gray Teleconference (January 30, 2020)
- Speaker, “Navigating the Intersection Between Litigation Tactics and Regulatory Issues,” FDLI Enforcement, Litigation, and Compliance Conference (December 11-12, 2019)
- Speaker, “With Great Influence Comes Great Responsibility,” FDLI 2019 Symposium (November 15, 2019)
- Speaker, “Mini Summit XXIII: Social Media Engagement by Manufacturers,” 21st Annual Pharmaceutical and Medical Device Compliance Congress (November 4-6, 2019)
- Presenter, “Violations, Enforcement and International Issues” Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation, Washington, D.C. (October 2, 2019)
- Moderator, “Focus on Investigations: Government Trends and Best Practices for Internal Investigations,” FDLI Annual Conference (May 2-3, 2019)
- Speaker, “Outlook 2019,” Ropes & Gray Teleconference (January 23, 2019)
Education
- JD, New York University School of Law, 2003
- BA, Columbia College, 1997