Regulatory Focus™ > News Articles > Woodcock Testifies on PDUFA, FDA Drug Approval Performance

Woodcock Testifies on PDUFA, FDA Drug Approval Performance

Posted 02 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) top drug regulator, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, testified Friday, 30 March before the Senate Health, Education, Labor and Pensions (HELP) Committee to advocate for the expedited approval of the Prescription Drug User Fee Act(PDUFA) and to tout FDA's historical accomplishments and its path forward.

Speaking on the PDUFA legislation, Woodcock said the legislation has "led to the reversal of the drug lag that prompted its creation," bringing drugs to the US market first in roughly 40% of all cases in 2010. Before PDUFA, the US only approved a drug before other markets in 3% (1985) to 27% (1991) of the time.

"Of the 35 innovative drugs approved in FY 2011, 24 (almost 70%) were approved by FDA before any other regulatory agency in the world, including the European Medicines Agency," continued Woodcock. "Of 57 novel drugs approved by both FDA and the EU between 2006 and 2010, 43 (75%) were approved first in the United States."

Woodcock also touted the agency's use of PDUFA funds. The agency has been able to "provide a large body of technical guidance to industry that clarified the drug development pathway for many diseases" as a result of the increased funding, said Woodcock.

The agency is also looking to make improvements, explained Woodcock.

"For example, FDA is working to improve the science behind certain clinical trial designs," said Woodcock. "Improving the scientific bases of these trial designs should add efficiency to the drug review process, encourage the development of novel products, and speed new therapies to patients."

Read more:

FDA - FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients (Janet Woodcock)

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