The US Food and Drug Administration (FDA) is caught between Scylla and Charybdis, with competing pressures to speed drugs to market and to ensure they are safe and effective. On one side, patients, families, and advocates are clamoring for faster approval of new drugs that offer treatments for serious and life-threatening diseases. They believe that delay is potentially deadly. Drug companies concur, eager to push new drugs to market as quickly as possible to start generating revenue. On the other side, recalling experiences with thalidomide, rofecoxib, bevacizumab, and other ineffective or harmful drugs, physicians and watchdog groups worry about the safety, real-world efficacy, and financial waste inherent in the rapid approval of drugs that eventually prove to be unsafe or ineffective.
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DiMagno SSP, Glickman A, Emanuel EJ. Accelerated Approval of Cancer Drugs—Righting the Ship of the US Food and Drug Administration. JAMA Intern Med. Published online May 28, 2019. doi:10.1001/jamainternmed.2019.0584
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