Mikkael A. Sekeres on the FDA: From Public Health Crises to Trust and Safety
I actually think we should celebrate the FDA's safeguarding the health of the public just as much as we celebrate when the FDA brings a drug to market that's highly effective and safe.
What makes the FDA the ultimate gatekeeper for drug safety and efficacy in the US? In this compelling episode, Marshall Poe sits down with Mikkael A. Sekeres, an oncologist and former chair of the FDA's cancer drug advisory committee, to discuss his book, 'Drugs and the FDA: Safety, Efficacy, and the Public's Trust'. Sekeres takes listeners through the FDA's fascinating history, shaped by public health crises and patient advocacy.
Ever wondered how a series of tragedies led to the stringent regulations we have today? Or why the FDA's approval process can be both a life-saver and a point of contention? This episode unpacks these questions and more. Sekeres dives into the contentious hearings on the breast cancer drug Avastin, shedding light on the complex decisions behind drug approvals.
He also shares his thoughts on accelerated drug approval processes, clinical trials, and how patients can better understand the risks and benefits of new treatments. Whether you're curious about the inner workings of the FDA or interested in how public health policies evolve, this episode offers a rich tapestry of insights that will keep you engaged from start to finish.