The US Food and Drug Administration (FDA) is tasked with determining whether investigational drugs are safe and effective, and with approving new drugs quickly enough for patients in need. To meet both objectives, the FDA must strike a balance between speed and safety. An excessively slow approval process may lead to lives lost among those who could have benefited from safe and effective drugs brought to market sooner. However, rapid approvals risk adverse events, including deaths. To strike a balance between inherent trade-offs in drug approval, the FDA ought to be managing risk, not minimizing it.
Authors: A Jena, D Lakdawalla, et al
Source: JAMA Oncology
Publication Year: 2016