Near-record drug approvals


A near-record 35 innovative drugs were approved by the US Food and Drug Administration (FDA) in the 2011 fiscal year, which ended September 30. The FDA beat other agencies around the world in its approval times, with 24 of those 35 products approved before any other agencies, including the European Medicines Agency, according to an annual performance report under the auspices of the Prescription Drug User Fee Act (PDUFA). “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA,” says FDA commissioner Margaret Hamburg. That set of 35 includes 10 for treating rare or orphan diseases and 7 new cancer treatments—among them, one for melanoma and another for lung cancer, each of which was approved along with a diagnostic test to identify which patients are most likely to benefit from those treatments. Nearly half of the group was approved under 'priority review', two-thirds within a single review cycle, and three under the 'accelerated approval'. “Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere,” says Janet Woodcock, director of the FDA Center for Drug Evaluation and Research. “As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.” This year's approvals are second only to 2009 when 37 new drugs were approved.


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Fox, J. Near-record drug approvals. Nat Biotechnol 29, 1066 (2011).

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