Bloomberg News

FDA Touts Pace of Its Drug Approvals Over European Counterparts

November 13, 2011

Nov. 3 (Bloomberg) -- U.S. regulators logged the second- highest approval rate for new drugs in a decade in fiscal 2011, clearing at least two dozen cancer medicines and other compounds before European counterparts.

The Food and Drug Administration singled out 17 new treatments as “particularly notable” for their effect on patients, in a report released today. The list includes Zytiga, the prostate cancer drug from New Brunswick, New Jersey-based Johnson & Johnson, and Zelboraf, the melanoma treatment from Basel, Switzerland-based Roche AG.

Overall, the FDA cleared 35 drugs, the most since 37 were approved in 2009, the agency said. Twenty-four hadn’t yet been cleared in Europe, the FDA said. Congressional Republicans have criticized the pace of agency reviews, pointing to last-minute requests for more safety data and conflict-of-interest rules that discourage scientists from sitting on advisory panels.

The approval rate is “a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients” FDA Commissioner Margaret Hamburg said in a statement.

The report comes as the U.S. Congress is debating renewal of a user-fee system that funds the agency’s drug reviews. The FDA and the drug industry agreed to a 6 percent fee increase as part of a plan to reauthorize user fees through fiscal 2017. Drugmakers would pay $712.8 million in fees in fiscal 2013 under the deal Congress must approve before Sept. 30, 2012.

Two other compounds singled out by the FDA treat hepatitis C, and the agency also cited Human Genome Sciences Inc.’s Benlysta, the first new lupus therapy in 50 years. Twelve of the 17 noteworthy drugs won U.S. clearance ahead of other countries, according to the report.

Expedited Reviews

The results track with FDA efforts to expedite reviews of medicines for undertreated conditions. The agency approved six cancer drugs ahead of schedule in the past 16 months, compared with none in 2008 and 2009, as regulators zeroed in on cancers with few treatments, according to a review of agency approval documents. Most cancer treatments are given a six- or 10-month window for agency evaluations.

Richard Pazdur, director of the FDA’s cancer office, said approvals may accelerate as part of a September reorganization of his office that focuses drug evaluation teams on afflicted body parts instead of the treatment’s composition.

The agency attributed its speed to authorities that allow it to expedite certain drug reviews, flexibility in clinical trial requirements and user fee resources, according to the report.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the agency didn’t experience “a huge uptick” of applications from drugmakers. Though in previous years, she said, many applications were for drugs that made moderate advances.

“This year we’re just seeing a lot of innovation.”

--Editors: Adriel Bettelheim, Chris Staiti

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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