People

Lisa Dwyer specializes in legal and policy matters relating to drugs and devices. A partner in our FDA and Life Sciences practice, Lisa strategizes with leading companies on regulatory, litigation and policy matters to achieve business objectives.

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, laboratory-developed tests (LDTs), opioid misuse and abuse, cosmetic regulation, data transparency, 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: advertising and promoting medical products; laboratory developed tests; real world evidence; expanded access;administrative law trends; preemption; the 21st Century Cures Act; and other topics. She was honored with the FDA Commissioner’s Special Citation for Issuance of Draft Guidance for Laboratory-Developed Tests in 2015, and for Issuance of the Unique Device Identification (UDI) System Final Rule in 2014. She has also been the recipient of several FDA group awards, and was recognized for her ability in Government Relations by Legal 500 in 2016.

Full Bio

Credentials

District of Columbia

Massachusetts

Pennsylvania

Recognition for Government Relations


Legal 500, 2016

FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests


FDA Award Ceremony, 2015

FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document


FDA Award Ceremony, 2015

FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule


FDA Award Ceremony, 2014

FDA Group Recognition Award, FDA Language Access Plan Working Group


FDA Award Ceremony, 2014

FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)


FDA Award Ceremony, 2012

FDA Group Recognition Award, Menu Labeling Working Group


CFSAN/FDA Award Ceremony, 2011

Matters

Regulatory counseling for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Engaging with FDA and Congress on key business issues affecting pharmaceutical and device manufacturers.

Preparing comments on proposed rules and draft guidance issued by FDA on behalf of pharmaceutical and device manufacturers.

See more
Icon close

Close

Matters

Regulatory counseling for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Engaging with FDA and Congress on key business issues affecting pharmaceutical and device manufacturers.

Preparing comments on proposed rules and draft guidance issued by FDA on behalf of pharmaceutical and device manufacturers.

Developing legislative strategies for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Matters

Regulatory counseling for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Engaging with FDA and Congress on key business issues affecting pharmaceutical and device manufacturers.

Preparing comments on proposed rules and draft guidance issued by FDA on behalf of pharmaceutical and device manufacturers.

See more
Icon close

Close

Matters

Regulatory counseling for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Engaging with FDA and Congress on key business issues affecting pharmaceutical and device manufacturers.

Preparing comments on proposed rules and draft guidance issued by FDA on behalf of pharmaceutical and device manufacturers.

Developing legislative strategies for pharmaceutical, device and personal care product (cosmetics) manufacturers and trade associations.

Credentials

District of Columbia

Massachusetts

Pennsylvania

Recognition for Government Relations


Legal 500, 2016

FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests


FDA Award Ceremony, 2015

FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document


FDA Award Ceremony, 2015

FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule


FDA Award Ceremony, 2014

FDA Group Recognition Award, FDA Language Access Plan Working Group


FDA Award Ceremony, 2014

FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)


FDA Award Ceremony, 2012

FDA Group Recognition Award, Menu Labeling Working Group


CFSAN/FDA Award Ceremony, 2011