Anand Shah, M.D. is the Deputy Commissioner for Medical and Scientific Affairs. Dr. Shah leads the agency’s operations as it relates to medical and scientific affairs. He is responsible for developing and leading high-priority FDA policy initiatives and oversees cross-agency teams in support of FDA’s public health mission.
Dr. Shah’s efforts have focused on improving medical outcomes and lowering costs, redesigning health care delivery, and expanding competition and consumer choice. Previously at FDA, he provided guidance to industry and academia on medical product development, clinical trial design, and regulatory pathways to accelerate public access to safe and effective therapies. He co-led and scaled Information Exchange and Data Transformation (INFORMED), a science and technology incubator designed to harness the power of real-world evidence and advanced analytics to improve disease outcomes.
He recently served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS). As Senior Medical Advisor, he was the primary counselor to the Administrator for agency-wide policy related to medical and scientific innovation. Dr. Shah established consensus on several critical policy initiatives including aligning payment and prevention to increase Medicare beneficiaries’ access to novel antimicrobials, expanding patients’ access to new cell and gene therapies, and streamlining Medicare access to breakthrough technologies. He led a significant cross-agency effort to bridge gaps in access that patients often encounter between FDA approval and CMS coverage of medical products. As the Chief Medical Officer of the Center for Medicare & Medicaid Innovation (CMMI), Dr. Shah led the clinical design of novel value-based payment and service delivery models including those for advanced primary care, specialty care, and prescription drugs.
Dr. Shah is an attending radiation oncologist at the National Institutes of Health (NIH) where he specializes in the early detection, surveillance, and treatment of prostate cancer. He developed and leads an NIH survivorship clinic in the care of patients on cancer clinical trials.
Dr. Shah served as an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania. He has led the development and evaluation of novel risk-based Medicare payment and health care delivery models at Columbia Business School. He completed a health economics fellowship at the University of Pennsylvania where he developed and applied significant expertise with economic, financial, and valuation modeling of emerging therapeutics. Dr. Shah was on Duke University faculty where he led the Center for Excellence in Surgical Outcomes as its Associate Director. He has received research funding from government and philanthropic sources. His scientific track record includes publications in the New England Journal of Medicine, JAMA, Health Affairs, Cancer, and Nature Reviews Drug Discovery. Prior to his government service, Dr. Shah served as an advisor to a U.S. venture capital firm.
Dr. Shah was chief resident during his radiation oncology residency at Columbia University. He concurrently earned his M.D. from the University of Pennsylvania and an M.P.H. in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics. He also served as a Canada-U.S. Fulbright Scholar.