Hogan Lovells US LLP

Pharmaceuticals and Biotechnology

Partner

After 25 years in senior legal and policy positions at the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), including HHS Deputy General Counsel and FDA Director of Drug Compliance, David Horowitz achieves results for clients by helping them anticipate, communicate, and work effectively with regulators and policy makers.

He represents life sciences clients on FDA compliance and regulatory policy issues, including responding to FDA warnings and compliance actions, import and export issues, current good manufacturing practice (GMP) requirements, drug shortages, registration/listing, pharmacy/compounding issues, Over-the-Counter (OTC) drugs, and user fees.  His insight into FDA’s requirements, statements, and actions allows him to identify solutions that satisfy the clients’ business needs within FDA’s regulatory framework.

Prior to joining Hogan Lovells, he served as Deputy General Counsel at HHS, advising the Secretary of HHS on FDA issues and overseeing the lawyers at FDA, CDC and NIH.  Before this role, he worked for over 17 years in senior legal and compliance positions at FDA, including as Director of Compliance for the Center for Drug Evaluation and Research (CDER), Assistant Commissioner for Policy, and Associate Chief Counsel for Drugs.

English

J.D., University of Virginia School of Law; B.A., Brown University, magna cum laude