Amy E. Speros

Amy Speros is Counsel in the San Diego and Washington, D.C. offices of Latham & Watkins. She advises clients on regulatory, compliance, and transactional matters in industries overseen by the Food and Drug Administration (FDA) and other federal health agencies, including the pharmaceutical, biotechnology, medical device, food, dietary supplement, cosmetic, and tobacco industries.

Amy assists clients with all aspects of the FDA-regulated product life cycle, including, among others:

• Pre-market development and testing
• FDA product submissions
• Market exclusivity strategies, including orphan drug issues
• Labeling and post-market safety concerns, including Risk Evaluation and Mitigation Strategy (REMS) programs
• FDA and Federal Trade Commission (FTC) regulation of product marketing and promotion
• FDA and Drug Enforcement Administration (DEA) export and import requirements
• Clinical trial, manufacturing, distribution, and other corporate contracts
• FDA inspections and recalls
• Civil and criminal compliance and enforcement

In the transactional area, Amy provides regulatory advice on diligence and disclosure matters for large public offerings, mergers and acquisitions, and private transactions. Amy frequently collaborates with patent litigation and licensing teams to provide synergistic intellectual property and regulatory strategy advice. She has also been involved extensively in Administrative Procedure Act (APA) litigation, providing key regulatory expertise in Latham’s unmatched track record of success in FDA-related APA suits. Amy has contributed to key precedent-setting decisions, including:

• Eagle Pharmaceuticals Inc. v. FDA, 2018 WL 3838265 (D.D.C. 2018), aff’d 952 F.3d 323 (D.C. Cir. 2020);
• Catalyst Pharmaceuticals Inc. v. FDA, 14 F.4th 1299 (11th Cir. 2021);
• Endo Par Innovation Co., LLC v. FDA, 1:23-cv-00999 (D.D.C. 2024); and
• Jazz Pharmaceuticals, Inc. v. FDA and Avadel CNS Pharmaceuticals, LLC, 2024 WL 4625731 (D.D.C. 2024), aff’d 141 F.4th 254 (D.C. Cir. 2025).

In 2022, Amy was recognized as a Woman Worth Watching in STEM in the Profiles in Diversity Journal. She frequently contributes to thought leadership and is an active member of the Food and Drug Law Institute.

Amy is a recognized mentor in the Latham community and has served in several leadership positions within Latham’s Global Training and Career Enhancement (TACE) Committee and Women Enriching Business (WEB) Commitee. She maintains an active pro bono practice assisting veterans and asylum seekers in government applications and appeals.