Hutt, Peter BartonSung, Andrew J.2012-06-072005Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform (2005 Third Year Paper)http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852102The 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.en-USFood and Drug Lawoncologydrug approvalPaper (for course/seminar/workshop)2012-06-07