Who Funds the FDA - And Why Does It Matter?

Science for the Public: Contemporary Science Issues and Innovations
June 07, 2022 Belmont Media Center, Belmont MA

Aaron S. Kesselheim, M.D., J.D., M.P.H., Professor of Medicine, Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL); Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.

The Food and Drug Agency (FDA) was established in 1938 to ensure the quality of foods and medications. At the time, many medications and processed foods contained impurities and toxins that were threatening public health. When the FDA took charge of testing and guaranteeing the safety of products it represented the public interest and was funded by the taxpayer, not the pharmaceutical and food companies. That situation began to change in the 1980s when a special arrangement was initiated in which pharmaceutical companies paid fees to the FDA that were meant to expedite the testing and approval of new medications. The public is largely unaware of this partnership between the regulator (FDA) and the regulated (pharma industries). Dr. Kesselheim explains the background and the increasing concerns about this arrangement.

Background