REBECCA WOOD is global co-leader of the firm’s Food, Drug and Medical Device (FDMD) practice, serves on Sidley’s Global Life Sciences Leadership Council, and leads Sidley’s Washington, D.C. Healthcare and FDMD group.
Becky provides counsel on a wide range of contentious and non-contentious U.S. Food and Drug Administration (FDA) regulatory, compliance, and litigation issues to companies and investors in the life sciences industry. Becky handles high-stakes and significant FDA matters, including FDA supervisory review, appeals, and hearings; gene therapy, cell therapy, and regenerative medicine regulatory and compliance issues; medtech, AI, and digital health regulatory and compliance issues; impact litigation involving FDA-regulated products; FDA and tort considerations regarding federal preemption; and First Amendment/free speech issues relating to promotional speech and commercial complaints. A significant aspect of her practice involves leading cross-disciplinary teams navigating regulatory, compliance, enforcement, and litigation matters involving FDA-regulated products.
Becky “is among the foremost FDA experts around, and is responsive and client-friendly.”
Chambers USA 2023
Becky previously served as Chief Counsel (general counsel role) to the FDA under former Commissioner Scott Gottlieb, M.D. She led the Office of the Chief Counsel of the FDA, the office within the agency that provides legal advice about counseling, litigation, and enforcement matters arising under the Federal Food, Drug, and Cosmetic Act and the Public Health Act. Becky advised FDA leadership, including the Office of the Commissioner, the Office of Regulatory Affairs, and the product centers that regulate biological products (Center for Biologics Evaluation and Research (CBER)), drugs (Center for Drug Evaluation and Research (CBER)), medical devices (Center for Devices and Radiological Health (CDRH)), food and cosmetics (Center for Food Safety and Applied Nutrition (CFSAN)), tobacco (Center for Tobacco Products (CTP)), and veterinary medicine (Center for Veterinary Medicine (CVM)) about major initiatives and litigation matters.
“She understands the way the FDA looks at things and how best to approach them.”
Chambers USA 2022
Becky’s role at FDA gives her a singular perspective on today’s regulatory environment, as well as insights into the complex issues that our clients face. At FDA, she worked on virtually every significant initiative addressed by the Commissioner and agency leadership. She was the principal legal adviser on major initiatives including efforts to streamline the drug and device development approval process, modernize the agency’s regulatory framework, and enhance the product safety and labeling of food and medical products. She also focused on First Amendment and preemption issues.
Becky serves as an Adjunct Professor at New York University School of Law where she co-teaches a course on Food and Drug Law, Policy, and Advocacy.
Prior to her time in government, Becky served as lead counsel on numerous litigation matters involving FDA regulatory issues and bet-the-company litigation. Becky has significant experience in multidistrict litigation and coordination, federal removal and jurisdiction issues, federal preemption, class actions and multi-plaintiff cases. Her expansive appellate experience includes merits and amicus briefing to the U.S. Supreme Court, as well as litigating dispositive and post-trial motions, appeals, and petitions for interlocutory appeal and mandamus relief for a variety of clients in federal and state courts nationwide.
Becky has been recognized by Chambers USA for her work in Nationwide Life Sciences: Regulatory/Compliance (2023–2024) and Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia (2021–2024). In the 2023 edition, clients say that Becky’s “background at the FDA is extremely valuable and she has an excellent communication style” and that she is “really pragmatic in her advice.” In the 2022 edition of Chambers USA, a client lauds Becky’s experience: “She is a great strategist and provides elegant solutions to problems.”
In addition to her recognition by Chambers USA, Becky has been honored by the following government and private practice awards:
- LMG Life Sciences “Life Sciences Star” (2022–2024).
- The National Law Journal “Healthcare and Life Sciences Trailblazer” (2021).
- 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 (2018)