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Meredith Manning

Partner
Washington, D.C.
Denver

Meredith Manning
Phone
+1 202 637 6585 (Washington, D.C.)
+1 303 899 7385 (Denver)
Fax
+1 202 637 5910 (Washington, D.C.)

For over 20 years, Meredith Manning has counseled clients on emerging legal issues of pharmaceutical regulatory law. Her goal is to help companies get drugs approved and help them succeed. Her first client was the FDA, and she now advises companies of all sizes on cutting-edge regulatory compliance issues. Clients value her "client service-oriented nature" and "the practicality of her advice."

Meredith's focus extends from clinical trials to good manufacturing practices, drug safety, and advertising and promotion. She watches emerging issues over time, applies her insights into regulators' thinking, and works with clients to build practical approaches to critical business processes and strategies.

Meredith works on major investigations into off-label promotion, client responses to FDA warning and untitled letters, and competitor complaints. She also guides client decisions about drug advertising, drug sampling, patient support programs, and comprehensive pharmaceutical compliance programs. In this role, she has helped develop business strategies for several of the largest drug launches in recent years.

She began her legal career in the Office of Chief Counsel at the FDA and moved to the DOJ as an Assistant United States Attorney for the District of Columbia. She's been at Hogan Lovells since 2002, has served as the co-director of the firm's Pharmaceutical Practice Group, and currently sits on the steering committee for its Life Sciences industry team.

Meredith is nationally ranked in Chambers USA, Legal 500, and LMG Life Sciences. In 2012, the American Health Lawyers Associate named her a Pro Bono Champion for her work on an HIV and AIDS project in D.C. She also serves on the Board of Trustees of the Emma Willard School in Troy, New York.

"Meredith Manning focuses her energies on both routine and on extraordinary client needs for drug companies. This dual approach serves her clients well, as it prevents emergent issues from growing. On-going service to her clients includes counseling on day-to-day compliance problems such as clinical trials, [and] advertising and promotion..."

LMG Life Sciences

Representative Experience

Lead regulatory counsel in a major federal misbranding investigation.

Lead a team advising on patient support programs designed to support launch of a major oncology drug.

Handled an OIG advisory opinion request regarding a free drug program.

Routinely review proposed promotional materials and programs for major drug products sold in the U.S.

Craft responses to FDA enforcement letters on GMP and drug advertising.

Education and admissions

Education

  • J.D., Order of the Coif, University of Minnesota Law School, 1993
  • M.S., University of California, Los Angeles School of Public Health, 1990
  • B.A., cum laude, Duke University, 1984

Memberships

  • American Health Lawyers Association
  • Member, Food, Drug, and Law Institute

Bar admissions and qualifications

  • Colorado
  • District of Columbia

Court admissions

  • U.S. Court of Appeals, District of Columbia Circuit
  • U.S. District Court, District of Columbia

2010-2011, 2014-2016

Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers USA

2014-2015

Food and Drugs

Washington, D.C. Super Lawyers

2004, 2009, 2011, 2014

Washington's Top Lawyers: Food and Drug

Washingtonian

2013-2014

Administrative Law

Washington, D.C. Super Lawyers

2014

Healthcare: Life Sciences

Legal 500

2012

Pro Bono Champion

American Health Lawyers Association

2011-2012

Regulatory

PLC Life Sciences Cross-border Handbook

2010-2012

Healthcare/Pharma

Ethisphere, Attorneys Who Matter

2007-2009

USA - Life Sciences: Regulatory, Highly Recommended

PLC Which Lawyer?

2007

Food and Drug Administration

Washington, D.C. Super Lawyers

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