We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

David Horowitz

Partner
Washington, D.C.

David Horowitz

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) to help clients anticipate and navigate regulatory challenges, and to participate in the policy-making process.

As Deputy General Counsel at HHS (2010-2017), David oversaw and coordinated legal services in support of FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and international and emergency preparedness programs. His work focused on FDA regulatory policy and litigation. During his tenure at FDA — which included five years as head of the Office of Compliance for drugs, and three years as Assistant Commissioner for Compliance Policy — David played a leadership role in major initiatives, including the modernization of FDA's approach to pharmaceutical manufacturing quality and the agency's efforts to develop and implement a more scientific, risk-based approach to inspection and enforcement.

Over the course of his career at HHS and FDA, David developed substantial knowledge pertaining to FDA law and policy, with particular emphasis on pharmaceuticals, compliance, and the application of administrative law. He also developed a deep understanding of the institutions, organizational structures, procedures, and cultures through which regulatory policy and compliance decisions are considered, developed, and implemented across all branches of government, including Congress and the courts, as well as various components of FDA, HHS, Office of Management and Budget, Department of Justice, and the White House.

Representative experience

Lead agency counsel for all HHS legal issues relating to Ebola outbreak, including FDA Emergency Use Authorizations and vaccine development and liability matters*

FDA leader in developing internationally harmonized pharmaceuticals guideline on Quality Risk Management, ICH Q9*

Lead agency counsel for final rules pertaining to human subject protection and clinical trial reporting*

*Matter handled prior to joining Hogan Lovells.

Education and admissions

Education

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

Bar admissions and qualifications

  • District of Columbia
  • Pennsylvania

Court admissions

  • U.S. Supreme Court
  • U.S. Court of Appeals, 5th Circuit

2015

Distinguished Service and Leadership Award

Food and Drug Law Institute

2016

Meritorious Service

Presidential Rank Award

2010, 2015

HHS Certificate of Appreciation

HHS

2011

NIH Director's Award

NIH

1994, 1998, 2005, 2006, 2015

FDA Commissioner's Special Citation

FDA

1999, 2007

FDA Award of Merit

FDA

Loading data