Overview
Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimerās drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drugās safety and efficacy? In Drugs and the FDA, Mikkael Sekeresāa leading oncologist and former chair of the FDAās cancer drug advisory committeeātells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices.Ā
Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDAās evolution, demonstrating how its system of checks and balances worksāor doesnāt work.
This book title, Drugs and the FDA (Safety, Efficacy, and the Public's Trust), ISBN: 9780262548397, by Mikkael A. Sekeres, published by MIT Press (February 6, 2024) is available in paperback. Our minimum order quantity is 25 copies. All standard bulk book orders ship FREE in the continental USA and delivered in 4-10 business days.
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