Assistant Director for Biomedical Regulatory Policy
White House Office of Science and Technology Policy
Grail Sipes, J.D. serves as Assistant Director for Biomedical Regulatory Policy at the White House Office of Science and Technology Policy (OSTP), where her portfolio includes clinical trial infrastructure, related preparedness issues, and other matters related to the development and marketing of medical products. For ten years prior to her work at OSTP, Grail worked in a variety of roles at the FDA, most recently serving as Deputy Director for Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, she was a lawyer in private practice and a partner at Covington & Burling LLP. At FDA, Grail worked on a wide range of matters involving drugs and other FDA-regulated products, including reproductive health, drug pricing and access, drug shortages, digital health, and First Amendment challenges to regulation. At FDA and at OSTP, Grail’s role has been to develop effective public health strategies and policies in light of evolving science, differing stakeholder viewpoints, and various regulatory challenges.