REBECCA WOOD is co-leader of the firm’s Food, Drug and Medical Device practice, serves on Sidley’s Global Life Sciences Leadership Council, and leads Sidley’s Washington, D.C. Healthcare and FDA group.
Becky previously served as Chief Counsel (general counsel role) to the Food and Drug Administration (FDA) under former Commissioner Scott Gottlieb, M.D. 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. Chambers USA observed that Becky “has extensive knowledge of FDA regulations and provides counsel for a range of clients, including pharmaceutical, device and diagnostic manufacturers” (2021 and 2022). Chambers reports:
- Becky “is extremely knowledgeable and responsive. She is a great strategist and provides elegant solutions to problems.”
- “She’s excellent to work with. She is very knowledgeable, responsive and great at clearly articulating complicated issues.”
- “A seasoned FDA adviser who is really good at sharing her knowledge.”
- “She understands the way the FDA looks at things and how best to approach them.”
- “She's a great litigator.”
Becky focuses her practice on providing counsel on a wide range of contentious and non-contentious FDA regulatory and litigation issues to clients and investors in the life sciences industry. Recent experience includes assisting clients with a number of high-stakes and significant FDA matters, including:
- FDA supervisory review, appeals, and hearing requests
- Gene therapy, cell therapy, regenerative medicine regulatory and compliance issues
- Medtech and digital health regulatory and compliance issues
- Impact litigation involving FDA-regulated products
- FDA and tort considerations regarding federal preemption
- First Amendment/Free Speech issues relating to promotional speech and commercial complaints
Becky was a founding member of 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.
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.
In addition to Chambers, government and private practice honors include:
- LMG Life Sciences “Life Sciences Star” (2022)
- The National Law Journal (NLJ) (2021) “Healthcare and Life Sciences Trailblazer”
- FDA Honor Awards (2018) 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.
- The International Who’s Who of Product Liability Defence Lawyers (2013, 2012) as “consistently recognised as a top litigator in commercial and appellate trials, at both the state and federal level.”
- The Legal 500 US 2009 as “one of the best brief-writers on federal preemption.”