Beth Weinman is a member of Ropes & Gray's 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.
When not working, Beth enjoys spending time with her family, hiking, skiing, reading, and boxing for fitness.