People
A partner in our FDA and Life Sciences practice, Lisa has almost 25 years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.
Previously, Lisa served as a Senior Policy Advisor in the FDA Commissioner’s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency’s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).
Lisa is a frequent author and speaker on topics including: digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women’s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her “unending enthusiasm to take on client’s causes as her own."
J.D., George Washington University Law School, honors
B.A., Wesleyan University
District of Columbia
Massachusetts
Pennsylvania
July 22, 2025
Lisa Dwyer discusses the impact of the FDA recently publishing more than 200 rejection letters for new drug applications
June 11, 2025
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2025 Guide
Focus on Digital Health/Telehealth
Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests
FDA/FTC regulation of advertising and promotion
See more
September 11, 2025
Advancing Novel Treatments for Rare Diseases: FDA Unveils and Previews New Efforts to Assess Therapies for Very Small Patient Populations
September 10, 2025
HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion
August 4, 2025
Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry
July 22, 2025
Lisa Dwyer discusses the impact of the FDA recently publishing more than 200 rejection letters for new drug applications
June 11, 2025
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2025 Guide
Focus on Digital Health/Telehealth
Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests
FDA/FTC regulation of advertising and promotion
See more
September 11, 2025
Advancing Novel Treatments for Rare Diseases: FDA Unveils and Previews New Efforts to Assess Therapies for Very Small Patient Populations
September 10, 2025
HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion
August 4, 2025
Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry
July 22, 2025
Lisa Dwyer discusses the impact of the FDA recently publishing more than 200 rejection letters for new drug applications
June 11, 2025
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2025 Guide
J.D., George Washington University Law School, honors
B.A., Wesleyan University
District of Columbia
Massachusetts
Pennsylvania