+1 202 637 5678
+1 202 637 5910
Partner, Washington, D.C.
David Fox has a leading practice in the regulation of new drugs and biological products, and also maintains a practice in the field of combination products.
David served for more than six years with the Food and Drug Administration (FDA), as Assistant Chief Counsel for Enforcement from 1994 to 1995 and as Associate Chief Counsel for Drugs from 1995 to 2000.
He has extensive experience in the approval process for new drugs and biological products, as well as the regulation of generic and follow-on products. David works with pioneer pharmaceutical and biotechnology sponsors, and is frequently consulted on life cycle management issues, including Orphan Drug, Pediatric, and Hatch-Waxman exclusivity matters, patent listing and Orange Book issues, and implementation of section 505(b)(2) of the Food, Drug, and Cosmetic Act.
David assists clients in taking a critical approach to exclusivity issues, bioequivalence standards, dosage form innovations, and a range of questions related to pharmaceutical labeling. David works closely with Hogan Lovells' patent litigation and product liability teams, as well as the healthcare and white collar crime groups. He assists clients on corporate transactional matters, including assessment of opportunities in the life sciences markets, and he works closely with our European and Asian offices on providing global regulatory advice to the firm's pharmaceutical and biotechnology clients.
David also has extensive experience in the regulation of over-the-counter (OTC) drug products, controlled substances regulated by the Drug Enforcement Administration (DEA), drug naming and medication errors, user fees, advertising and promotion, and clinical trials. While at the FDA, David served as counsel to the Division of OTC Drug Products, counsel to the Office of Generic Drugs, and counsel to the Office of the Ombudsman and Chief Mediator (now the Office of Combination Products). In 2005, he published with a colleague a leading text on the regulation of combination products. Prior to joining the FDA, David spent five years as a trial attorney in private practice.
David has made numerous presentations on Hatch-Waxman issues, the Generic Drug Approval Process, Life Cycle Management for Pioneer Manufacturers, the Regulation of OTC Drug Products, and the FDA's Regulation of Combination Products.
Hogan Lovells Publications
26 February 2014
"FDA Revises Forms for Submission of Patent Information to the Orange Book: Federal Circuit Decision in Novartis AG v. Lee Alters Patent Term Adjustment." Pharmaceutical and Biotechnology Alert, Hogan Lovells
16 December 2013
"FDA Calls for Nominations of Difficult to Compound Drugs." Pharmaceutical and Biotechnology Alert, Hogan Lovells
26 June 2013
"Decision that design-defect claims against generic manufacturers are pre-empted may have broad impact." Supreme Court Alert, Hogan Lovells
07 January 2013
"Focus on Life Sciences Industry Trends for 2013." Life Sciences Alert, Hogan Lovells
04 October 2012
"FDA denies 5-year exclusivity to “stable esters” and confirms structure-based approach to exclusivity." Pharmaceutical and Biotechnology Alert, Hogan Lovells
01 December 2011
"FDA grants client first-time approval on insomnia drug." Pharmaceutical and Biotechnology Alert, Hogan Lovells
29 June 2011
"Preemption Defense Available to Generic Drug Manufacturers." Hogan Lovells Alert, Hogan Lovells
17 May 2011
"FDA's first major action on establishing user fees for biosimilar applications under PHSA 351(k)." Pharmaceutical and Biotechnology Alert, Hogan Lovells
16 March 2009
"Waxman Bill Creates Risks, Opportunities." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
01 December 2008
"FDA Issues Guidance on Antibiotic Patent Listing Law." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
27 October 2008
"New Law Provides Hatch-Waxman Exclusivities to Antibiotic Drugs." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
16 July 2008
"FDA Issues New Rule on Pharmaceutical Action Letters with Potential Implications for Securities Disclosure." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
29 January 2008
"FDA Interprets Controversial 180-Day Exclusivity Forfeiture Provision." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
02 June 2006
"Abigail Alliance: Creating a New Constitutional Right of Access to Experimental Drugs." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
23 December 2003
"President Signs The Pediatric Research Equity Act of 2003 Requiring Specific Assessment of Safety and Efficacy in Children." FDA Update, Hogan & Hartson LLP
01 December 2002
"FDA Holds Hearings on Regulation of Combination Products; Written Comments Due by January 2003." FDA Update, Hogan & Hartson LLP
01 November 2002
"The U.S. Food and Drug Administration's Implementation of the Bioterrorism Act: Applicability to Exporters of Products to the United States." Focus On, Hogan & Hartson LLP
01 November 2002
"FDA's Proposed Generic Drug Rule." Update, Hogan & Hartson LLP
07 February 2014
"Fresh From the Biotech Pipeline — 2013." Nature Biotechnology, Nature America, Inc.
"Controlled Substances: FDA and DEA Regulation of Pharmaceuticals." The Food and Drug Law Institute
"Fresh From the Biotech Pipeline — 2011." Nature Biotechnology, Nature America, Inc.
"Behind-the-Counter-Drugs: New Life for an Old Idea?" Update, FDLI
03 May 2007
"Defending Biologics: How the Unique Attributes of Biological Products Invite Different Approaches to Litigation." Mass Torts Litigation Committee, Vol. 5, No. 2, ABA Section of Litigation
01 December 2006
"Conducting Business With Compassion." Pharmaceutical Executive Europe
19 October 2006
"Outsourcing Operations to Developing Countries: Maintaining Corporate Social Responsibility." European Healthcare Law and Regulatory News, Informa UK Ltd
01 April 2005
"Combination Products: How to Develop the Optimal Strategic Path for Approval." FDAnews 2005
01 May 2002
"Reimportation of U.S. Pharmaceuticals Exported to Canada: Senator Dorgan Introduces a Bill in U.S. Congress." Hogan & Hartson L.L.P. Focus On FDA