Drugs and the FDA

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The FDA's evolution, shaped by public health crises and patient advocacy, is explored against the backdrop of contentious hearings on the breast cancer drug Avastin. While recent headlines have spotlighted the agency's approval of COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm, many remain unaware of how the FDA operates. Mikkael Sekeres, a leading oncologist and former chair of the FDA’s cancer drug advisory committee, reveals how the FDA became the world's most trusted regulatory agency. Its formation was driven by a series of tragedies, including children poisoned by contaminated vaccines, an antibiotic laced with antifreeze, and a morning sickness drug that caused severe birth defects. These events forced the government to ensure drug safety and efficacy. Before the FDA, drug manufacturers could market any concoction without accountability. Sekeres recounts these historical moments alongside his participation in the 2011 Avastin hearings, which tested a century of the FDA’s progress and highlighted the effectiveness of its checks and balances—or lack thereof. Through these narratives, the book illustrates the critical role of the FDA in protecting public health and the ongoing challenges it faces.