Lisa M Dwyer

Partner

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Lisa M. Dwyer is a partner in King & Spalding’s Washington, D.C. office and a member of the FDA & Life Sciences practice group.  Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products.  From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs.  In these roles, Lisa provided strategic counseling to FDA’s Commissioner and other senior leadership on the agency’s most significant and complex issues, including: off-label marketing, oversight of laboratory developed tests (LDTs), oversight of next generation sequencing LDTs/in vitro diagnostics (part of President Obama’s Precision Medicine Initiative), advancing antimicrobial drug development and use, modernizing the legislative framework for cosmetics (including user fees), public-private partnerships, menu labeling, implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, opioid misuse and abuse, and the Commissioner’s Transparency Initiative.  In addition, she often served as a liaison for the FDA or worked closely with other parts of the federal government, including the Department of Health and Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Drug Enforcement Administration, and Congress.

Before joining the FDA, Lisa practiced food and drug law at two prominent Washington D.C. law firms, where she advised clients on the impact of new legislative and regulatory developments; submitted extensive comments on proposed rules to FDA, the Federal Trade Commission, and the Social Security Administration; advised clients regarding corrective actions and recall strategies for FDA-regulated products; engaged in crisis management; and handled litigation matters in federal and state courts.

Publications & Presentations

  • Speaker, “Key FDA Initiatives,” FDA Panel, White House Briefing for Springboard Enterprises, Executive Office of the President of the United States, June 19, 2013.

  • Speaker, “The New Drug Approval Process:  Basic Concepts and Regulatory Approval Pathways,”  Introduction to Drug Law and Regulation, Food and Drug Law Institute, Nov. 5, 2009.

  • Author, “FDA Announces a Public Meeting and a Call for Comments Regarding the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools,” Sonnenschein, Nath & Rosenthal LLP E-Alert (Sept. 22, 2009).

  • Author, “Wyeth v. Levine - Supreme Court Rules 6-3 that FDA-Approved Labeling Does Not Preempt State Tort Claims,” Sonnenschein, Nath & Rosenthal LLP E-Alert (Mar. 6, 2009).

  • Author, “Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics,” chapter in Clinical Evaluation of Medical Devices, Principles and Case Studies Second Edition (K.M. Becker and J. Whyte, eds.) (2006). 

  • Author, “Dietary Supplements and Drug Constituents:  The Pharmanex v. Shalala Case and Implications for the Pharmaceutical and Dietary Supplement Industries,” chapter in Regulation of Functional Foods and Nutraceuticals:  A Global Perspective (2005).

  • Author, “Dietary Supplements and Functional Food Advertising:  The FTC Act and the Lanham Act,” chapter in Dietary Supplements and Functional Foods:  A Practical Guide to FDA Regulation (2001). 

  • Note, “Lender’s Relief from CERCLA’s ‘Rock and a Hard Place:’  The Asset Conservation, Lender Liability and Deposit Insurance Protection Act,” 3 Envtl. Law. 859 (1997).

Recognition

  • 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
ADMISSIONS
District of Columbia
Massachusetts
Pennsylvania