Sonia Nath

Practice Areas

Sonia is chair of Cooley’s global life sciences and healthcare regulatory practice group. She has deep experience in matters involving the US Food and Drug Administration (FDA). Sonia has been recognized in Chambers and The Legal 500, and was shortlisted for the LMG Life Sciences Regulatory Attorney of the Year (Medical Devices) in 2022, 2023 and 2024. Sonia draws on her nearly 12-year career at the FDA’s Office of the Chief Counsel, where she served as a litigation and enforcement attorney, to help clients with litigation, investigations, regulatory counseling, and transactional matters involving the laws and regulations enforced by the FDA.

Sonia’s litigation practice includes agency-facing litigation under the Administrative Procedure Act (APA). She has served as lead counsel on several FDA APA cases, including one of the first complaints filed against the agency after the US Supreme Court’s landmark ruling in Loper Bright, challenging the agency’s award of market exclusivity. In addition to administrative litigation, Sonia’s practice also includes conducting internal investigations and representing clients in criminal matters involving the FDA and FDA-regulated products.

Sonia’s counseling practice includes advising clients on FDA regulatory compliance matters across the full product life cycle. She works with early-stage companies to develop go-to-market strategies, working hand-in-hand with business leaders to ensure the chosen regulatory pathways align with overall business strategy, including plans for developing and protecting intellectual property. Sonia helps clinical stage companies navigate marketing exclusivities and routinely represents companies at pre-submission meetings with the FDA.

Sonia helps commercial-stage companies prepare for and respond to FDA inspections, including drafting responses to FDA Forms 483. She also supports clients in responding to Warning Letters and other letters of regulatory significance. In addition, she assists FDA-regulated entities with product launches, including by reviewing third-party agreements, along with labeling, advertising and promotional materials for compliance with the Federal Food, Drug, and Cosmetic Act and FDA regulations. Sonia has experience working across all FDA-regulated product areas, with a particular emphasis on the biotech and medtech industries – though she also works closely with food, dietary supplement and cosmetic companies.

The transactional side to Sonia’s practice involves advising investors, underwriters, and public and private businesses in buy-side and sell-side transactions, as well as in financings involving FDA-regulated products.

During her FDA tenure, Sonia gained subject matter experience across the gamut of FDA-regulated products – including prescription and over-the-counter drugs, medical devices, biologics, foods, cosmetics, dietary supplements and animal drugs. She negotiated dozens of civil consent decrees for the government, defended the FDA in lawsuits brought under the APA and the Freedom of Information Act, and handled False Claims Act litigation for the agency. Sonia also handled criminal investigations and prosecutions involving FDA-regulated products in her appointed role as a special assistant United States attorney (SAUSA) with the US Attorney’s Office for the Central District of California. She received numerous accolades for her government service – including the FDA’s Award of Merit (the agency’s highest recognition), the FDA Commissioner’s Award and the Department of Justice’s John Marshall Award (the DOJ’s highest award offered to attorneys).

Sonia began her legal career as a law clerk to Judge Roger W. Titus of the US District Court for the District of Maryland and worked at a large international law firm as a healthcare associate for several years before joining the FDA. Before attending law school, Sonia was a management consultant for PwC and IBM, where she developed and implemented solutions for complex business problems.