Ben Firschein

About Ben Firschein

Ben Firschein is a Regulatory Counsel for the U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs, where he focuses on regulatory policy related to drugs and biologics.Previously he served as Director of Government Affairs and Policy for the United States Pharmacopeia (USP). The organization sets quality standards for drugs, dietary supplements and food ingredients in the United States and throughout the world. He’s served in roles including Legislative Director and Counsel in the U.S. Congress and Staff in the California Legislature and he’s had leadership positions in the nonprofit world, including as a foundation board member.He graduated from the Columbia University School of Law and received his undergraduate degree from the University of California, Berkeley. He earned an LL.M. on Law and Government from American University’s Washington College of Law. He is a member of the Bar of the District of Columbia.

Experience

1. Regulatory Counsel, Office of Regulatory Affairs

   FDA

   Aug 2021 — Present

   Regulatory and policy expert in matters related to quality and safety of medicines. Work focuses on facilitating internal and external stakeholder policy development and providing advice and counsel.

Education

• University of California, Berkeley

  B.A., Social Sciences

  1983 — 1986

• Columbia Law School

  J.D., Law

  1986 — 1989

• American University, Washington College of Law (LL.M.)

  LL.M., Law and Government

  2002 — 2003