Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform

Abstract

The FDA has made great strides over the past twenty years in loosening drug approval regulations to speed important, life-saving treatments to market. However, recent controversies involving anti-depressants for children and the withdrawal of two popular arthritis drugs and a multiple sclerosis therapy have created fears within the cancer community that the FDA will revert to a more cautious, conservative approval policy. Although cancer patient advocates have legitimate concerns about the pendulum swinging back to a more conservative agency stance, the FDA and the Oncologic Drugs Advisory Committee (ODAC) do not appear to have embraced a more risk-averse philosophy. Instead, the public backlash against the FDA presents the agency with an excellent opportunity to facilitate improvements to the accelerated approval and fast-track regulations for the benefit of cancer patients.