People

A partner in our FDA and Life Sciences practice, Lisa has almost 20 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, 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:  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, digital health, in vitro diagnostics, the 21st Century Cures Act, and other topics.  She was honored with the FDA Commissioner’s Special Citation in 2014 and 2015, and she was the recipient of several FDA group awards between 2011 and 2015.  In 2016, Lisa was recognized for her ability in Government Relations by Legal 500.  In addition, in 2017 and 2019, she was recognized by Legal 500 as a Next Generation Lawyer, and praised for her “unending enthusiasm to take on client’s causes as her own.”

Full Bio

Credentials

J.D., George Washington University Law School, honors

B.A., Wesleyan University

District of Columbia

Massachusetts

Pennsylvania

Next Generation Lawyer


Legal 500, 2017 and 2019

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FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests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

Icon close

Close

Recognition

Next Generation Lawyer


Legal 500, 2017 and 2019

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

FDA/FTC regulation of advertising and promotion

Pre-market development (drugs and devices (including digital health products))

FDA product submissions (drugs and devices (including digital health products))

See more
Icon close

Close

Matters

FDA/FTC regulation of advertising and promotion

Pre-market development (drugs and devices (including digital health products))

FDA product submissions (drugs and devices (including digital health products))

Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space

- Lanham Act

- Unfair trade practice statutes (state and federal)

Engages FDA and Congress on key issues related to FDA-regulated products

Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s

Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics

Co-Chairs Women's Health Initiative

Member of Cannabis Steering Committee

Matters

FDA/FTC regulation of advertising and promotion

Pre-market development (drugs and devices (including digital health products))

FDA product submissions (drugs and devices (including digital health products))

See more
Icon close

Close

Matters

FDA/FTC regulation of advertising and promotion

Pre-market development (drugs and devices (including digital health products))

FDA product submissions (drugs and devices (including digital health products))

Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space

- Lanham Act

- Unfair trade practice statutes (state and federal)

Engages FDA and Congress on key issues related to FDA-regulated products

Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s

Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics

Co-Chairs Women's Health Initiative

Member of Cannabis Steering Committee

Credentials

J.D., George Washington University Law School, honors

B.A., Wesleyan University

District of Columbia

Massachusetts

Pennsylvania

Next Generation Lawyer


Legal 500, 2017 and 2019

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

Icon close

Close

Recognition

Next Generation Lawyer


Legal 500, 2017 and 2019

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