David Horowitz
Partner
Washington, D.C.

Biography
David Horowitz brings 25 years of combined
experience at the FDA and U.S. Department of Healthand Human Services (HHS) to help clients anticipate
and navigate complex regulatory compliancechallenges.
David’s practice focuses on pharmaceutical complianceissues, including Current Good Manufacturing Practice(CGMP), inspections, recalls, post-market reporting,import/export, drug supply chain security, pharmacy
issues, and OTC drug issues. During his time at HHS
and FDA, David developed a deep understanding of theinstitutions, organizational structures, procedures, andcultures through which regulatory policy andcompliance decisions are considered, developed, andimplemented across all branches of government. The
combination of his deep technical knowledge and yearsof experience allows David to provide strategic andtactical advice to proactively avoid regulatory problems,
as well as respond effectively to unanticipatedchallenges.
As Deputy General Counsel at HHS (2010-2017), David
oversaw and coordinated legal services in support of
FDA and other HHS public health agencies. His work
focused on FDA regulatory policy and compliancerelated issues. During his tenure at FDA – which
included five years as head of the Office of Compliancefor drugs, and three years as Assistant Commissioner
for Compliance Policy – David played a leadership rolein numerous major initiatives, including thePhone+1 202 637 5403

Fax
+1 202 637 5910

Emaildavid.horowitz@hoganlovells.com

Practices
Pharmaceuticals and Biotechnology
Regulatory
Administrative and Public Law
Government Relations and Public
Affairs

Industries
Life Sciences and Health Care

Areas of focus
Pharmaceuticals and Biotechnology
Cell, Tissue, and Gene Therapies
Product Development and Approval
Regulatory Inspections and cGMPOTC Drugs and Cosmetics

modernization of FDA's approach to pharmaceuticalmanufacturing quality and the agency's efforts todevelop and implement a more scientific, risk-based
approach to inspection and enforcement. He also led
the development of FDA’s first risk-based quantitativemodel used to prioritize drug manufacturing
inspections.

Education and admissions
Education

Representative experience

J.D., University of Virginia School ofLaw, 1991
B.A., Brown University, magna cum
laude, 1986

Advise companies on responding to FDA inspectional
observations (483s) and Warning Letters relating toCGMP requirements, resulting in successful resolutionof FDA findings.

Bar admissions andqualifications

Assist companies in resolving drug approval issues and
FDA complete response letters related to
manufacturing quality and GMP concerns.

District of Columbia
Pennsylvania

Provide actionable advice to companies to navigate
FDA's complex requirements for importing andexporting biological materials and drug products.

Court admissions

FDA leader in developing internationally harmonizedpharmaceuticals guideline on Quality Risk
Management, ICH Q9**Matter handled prior to joining Hogan Lovells.

Awards and rankings
Healthcare: Pharmaceutical/Medical Products
Regulatory, Rank 4, Chambers USA, 2022-2023
Healthcare: Life Sciences, Legal 500 US, 2018
Meritorious Service, Presidential Rank Award, 2016
Distinguished Service and Leadership Award, Foodand Drug Law Institute, 2015
NIH Director's Award, NIH, 2011
FDA Award of Merit, FDA, 1999, 2007
FDA Commissioner's Special Citation, FDA, 1994,1998, 2005, 2006, 2015
HHS Certificate of Appreciation, HHS, 2010, 2015

Latest thinking and events

U.S. Supreme Court
U.S. Court of Appeals, Fifth Circuit

News
Podcast: Talking the cureNewsFlorida still has a long way to go before it canbegin importing certain Canadian drugs
News
FDA warns animal drug companies overunapproved antimicrobials, identifying “publichealth concerns”
News
Inside the FDA Advanced Manufacturing
Technologies Designation Program
NewsU.S.: FDA enforcement of certain DSCSA
requirements delayed until November 2024
News
Can sterile drug manufacturers implement EU GMP
Annex 1 requirements before August?