Regulatory Focus™ > News Articles > Woodcock Touts FDA Success in Drug Approval

Woodcock Touts FDA Success in Drug Approval

Posted 08 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Director for the Center for Drug Research and Evaluation (CDER), Janet Woodcock, testified before the House Energy and Commerce Committee on 8 March to advocate for the passage of the Prescription Drug User Fee Act (PDUFA) and used the opportunity to tout FDA's recent drug approval accomplishments.

Woodcock, the nation's top drug regulatory official, was also happy to cite numbers showing FDA was able to approve most drugs before its European counterpart, the European Medicines Agency (EMA). She cited two studies that showed FDA was able to approve 70% of innovative drugs before EMA in 2011, and also approved more oncology products in a shorter amount of time on average.

Woodcock was also eager to highlight the successes of the agency's accelerated approval program, which uses surrogate endpoints as a substitute for full proof of efficacy. Eighty products have been approved under the program since its founding in 1992, including three in 2011.

Woodcock also called for the development of new antibiotic drugs, saying that the agency is at "a critical juncture in this field."

"We are in urgent need of new therapeutic options to treat the resistant bacteria that we currently face, and we will need new therapeutic options in the future. FDA will continue to work with patients, health care providers, academia, industry, and others within the federal government to modernize the paradigm of antibacterial drug development through guidance and clinical trial designs, and to seek additional solutions to the challenging scientific issues facing the field of antibacterial drug development," said Woodcock.


Read more:

Testimony: STATEMENT OF JANET WOODCOCK, M.D. DIRECTOR, CENTER FOR DRUG EVALUATION AND RESEARCH

FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain

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