BECKY WOOD leads Sidley’s Food, Drug and Medical Device Regulatory practice and the D.C. Healthcare and FDA group. She also serves on the firm’s COVID-19 Task Force, and advises FDA-regulated clients on a range of COVID-19 response efforts, including the regulation of Personal Protective Equipment (PPE), Emergency Use Authorizations (EUA) and immunity considerations under the PREP Act. Until recently, Becky served as Chief Counsel to the Food and Drug Administration (FDA). At FDA, she worked on virtually every significant initiative addressed by the Commissioner and agency leadership. She was the principal legal advisor on major initiatives including efforts to streamline the drug and device development approval process, modernize the agency’s regulatory framework, combat addiction to opioids and nicotine, enhance the product safety and labeling of food and medical products, and address drug pricing. She also focused on First Amendment and preemption issues.
This role gives her a unique perspective on today’s regulatory environment, as well as insights into the complex issues that our clients face. Becky focuses her practice on providing counsel on a wide range of contentious and non-contentious FDA regulatory and litigation issues to clients in the life sciences industry and private equity firms investing in the area.
Prior to her time in government, Becky served as lead counsel on numerous litigation matters involving FDA regulatory issues and company-threatening litigation. Becky has significant experience in multidistrict litigation (MDL) and coordination, federal removal and jurisdiction issues, federal preemption, class actions and multi-plaintiff cases, Frye and Daubert issues, and the defense of product liability and consumer fraud cases. Her expansive appellate experience also includes merits and amicus briefing to the United States Supreme Court, and briefing post-trial motions, appeals and petitions for interlocutory appeal and mandamus relief for a variety of clients in federal and state courts nationwide.
A sampling of Becky’s experience during her government service includes:
- Leading FDA’s Office of the Chief Counsel, the office within the agency that provides legal advice about counseling and litigation matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Act (PHA).
- Advising FDA leadership, including the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA), and the product centers that regulate biological products (CBER—Center for Biologics Evaluation and Research), drugs (CDER—Center for Drug Evaluation and Research), medical devices (CDRH—Center for Devices and Radiological Health), food and cosmetics (CFSAN—Center for Food Safety and Applied Nutrition), tobacco (CTP—Center for Tobacco Products), and veterinary medicine (CVM—Center for Veterinary Medicine) about major initiatives and litigation matters.
Becky’s experience in private practice includes:
- Serving as national counsel to several major life sciences companies in litigation involving pharmaceuticals and medical devices and the Federal Food, Drug, and Cosmetic Act and United States Constitution.
- Representing clients in major product liability cases at the trial level, primarily briefing key motions and preparing high-exposure cases for potential appeal.
- Merits and amicus briefing to the U.S. Supreme Court in numerous matters, including the Warner-Lambert v. Kent, Riegel v. Medtronic, Inc. and Wyeth v. Levine cases involving issues of federal preemption in the drug and medical device contexts. A client noted in The Legal 500 US (2009) that Becky “is one of the best brief-writers on federal preemption.”
Becky is a recipient of the 2018 FDA Honor Awards, Group Recognition – Crosscutting, Tobacco and Nicotine Regulation Communication Team for outstanding communications supporting the FDA’s announcement of a comprehensive plan for tobacco and nicotine regulation. While practicing at Sidley, Becky was recognized in The International Who's Who of Product Liability Defence Lawyers 2013 as “a top litigator in commercial and appellate trials, at both the state and federal level.” In addition to being recognized in The Legal 500 US, Becky was included in The International Who's Who of Product Liability Defence Lawyers 2012 and 2013. The 2013 edition of the guide said that “Rebecca Wood is noted for the ‘incredible breadth’ of her practice — she is consistently recognised as a top litigator in commercial and appellate trials, at both the state and federal level.”