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Who Funds the FDA - And Why Does It Matter?

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Date and time
Tuesday, June 7, 2022

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 concerns about this arrangement. Photo credit: Science for the Public

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Aaron S. Kesselheim, M.D., J.D., M.P.H., is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He is a member of the New York State Bar and is a Patent Attorney.
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