David M. Fox
Partner
Washington, D.C.

Biography
David Fox is a leading authority on the regulation ofprescription and over-the-counter drugs, biologicalproducts, combination products, and controlledsubstances.

Phone

He advises management teams, from start-ups to thelargest global pharmaceutical and biotechnology
companies, on matters before the Food and Drug
Administration (FDA) and Drug Enforcement
Administration (DEA). David is closely integrated withfunding sources for the industry and is frequently
retained as a strategic advisor on assessing the value oflife sciences assets. Known for his collaborative
approach to complex regulatory issues, David has
successfully resolved numerous disputes between
sponsors and staff at FDA on products that raise novel
regulatory issues. As a former senior lawyer for FDA
and throughout his career in private practice, David has
been deeply immersed in the regulatory side of the
Hatch-Waxman Act, including pioneer-generic disputes
and numerous cases of first impression involving
exclusivity issues, Orange Book listings, and patentterm extensions.

EmailDavid previously led our Pharmaceutical andBiotechnology practice group and served on the firm's
global Life Sciences management team.
During his FDA tenure, David received the Secretary’s
Award of Merit and an FDA Special Citation for his
work on the FDA Tobacco Rule. David is a founding
member of the Kitalys Institute to support interventions+1 202 637 5678

Fax
+1 202 637 5910

david.fox@hoganlovells.com

Practices
Pharmaceuticals and Biotechnology
Regulatory

Industries
Life Sciences and Health Care

Areas of focus
Controlled Substances and DEA
Pharmaceuticals and Biotechnology
Regulatory Exclusivities, HatchWaxman, and Similar Statutes
Cell, Tissue, and Gene Therapies
Combination Products
Artificial Intelligencethat delay the onset of diseases of aging, and David ison the Advisory Board of the Cancer Support
Community. David also serves as pro bono counsel ona variety of programs to improve patient and care-giverwelfare.

Awards and rankings
Life Sciences: Regulatory/Compliance (Nationwide),Band 1, Chambers USA, 2007-2023
Healthcare: Pharmaceutical/Medical Products
Regulatory (District of Columbia), Band1, Chambers
USA, 2010-2023
Life Sciences: Regulatory/Compliance (USA),
Chambers Global, 2021
Life Sciences Hall of Fame, LMG Life Sciences, 2020
FDA Law, Best Lawyers in America, 2018-2022
Healthcare: Life Sciences, Hall of Fame, Legal 500 US,
2019-2020,2023
Healthcare: Life Sciences, Leading Lawyer, Legal 500
US, 2013-2014, 2016-2018
Thought Leaders, USA, Life Sciences - Regulatory,
Who's Who Legal, 2023
Selected to Super Lawyers, 2013-2018
Washington's Top Lawyers: Food and Drug,
Washingtonian, 2009, 2011, 2013, 2014
Most Highly Regarded Firms for Life Sciences, Who's
Who Legal, 2013
Regulatory, PLC Life Sciences Cross-border
Handbook, 2011-2012
USA – Life Sciences: Regulatory, Recommended, PLC
Which Lawyer?, 2007-2009
FDA Award of Merit and Special Citation
Secretary's Award for Distinguished Service

Latest thinking and events
Hogan Lovells Events
Tokyo: Life Sciences and Health Care Horizons
2024

Education and admissions
EducationJ.D., New York University School ofLaw, 1989
B.A., College of William & Mary,
1985

Bar admissions andqualifications
District of Columbia
New York

Accolades"David Fox is recognized for thequality of his strategic counsel on
engagements with the FDA for 505(b)(2) New Drug Applications. 'I
would never do a pharmaceuticals
deal without his involvement. His
insights into FDA regulatory mattersis unparalleled,' says one impressedsource."

Chambers USA 2016
"David Fox is a go-to attorney forclients bringing new products
through review, as well as advisingon related IP issues."

Chambers USA"David is praised by clients for his'unsurpassed knowledge'
particularly in the fields of HatchWaxman and pharmaceutical life
cycle management. He is also

News
FDA seeks industry input on biosimilar guidancedevelopmentNews
FDA signals potential shift toward
interchangeability for all biosimilars
News
FTC disputes new slate of Orange Book patents forweight loss, diabetes, asthma, and COPD drugs
News
FTC disputes new slate of Orange Book patents forweight loss, diabetes, asthma, and COPD drugs
Hogan Lovells Events
Fireside chats with Hogan Lovells during JPM 2024

commended by observers for his'technical expertise, knowledge,counsel and insight.'"

Chambers 2015
"David is the 'real deal' with'extensive experience' advising on
product lifecycle management forthe pharmaceutical industry."

Who's Who Legal Life Sciences
2015"We love the tremendous expertisethat David Fox brings to ourstrategic product development
initiatives."

Chambers 2013