BioCentury
ARTICLE | Politics & Policy

FDA's Pazdur: FDA willing to take risks

October 30, 2013 12:53 AM UTC

FDA's Richard Pazdur, director of CDER's Office of Hematology & Oncology Products (OHOP), made it clear at an FDA briefing on personalized medicine on Monday that the agency is willing to take risks to get drugs for serious and life-threatening diseases to patients quickly. Pazdur said, "If we are taking appropriate risks in accelerated approval, some drugs will come off market, some will have restricted labeling." If that doesn't ever happen, "we probably aren't taking the appropriate risks," he said.

Pazdur's comments coincide with -- but were not in response to -- an analysis by a group of researchers from the Institute for Safe Medication Practices that was published in the Journal of the American Medical Association. The researchers said "many safety questions remain unanswered" for drugs that receive an expedited review by FDA, citing a shorter review time and fewer patients tested in clinical trials for those drugs compared with drugs approved via a standard approval. In an analysis of the 20 NCEs approved by FDA in 2008, eight took a median of 5.1 years of clinical development to obtain approval and were evaluated for efficacy in a median of 104 patients. By comparison, the 12 standard review drugs were developed for a median of 7.5 years prior to approval and were evaluated for efficacy in a median of 580 patients. The 2008 approvals include seven Orphan drugs, of which six qualified for expedited review. The researchers considered an expedited review to be Priority Review, Fast Track designation and accelerated approval. ...