Lisa Dwyer

Practice Areas

A partner in the firm's 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).

Ms. Dwyer 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.