David Horowitz

David Horowitz brings 25 years of combined experience at the U.S. Department of Health and Human Services (HHS) and the FDA to help clients anticipate and navigate regulatory challenges, and participating 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.