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FDA says drug approvals highest in two decades

Friday, July 8, 2011

Janet Woodcock, director of the FDA‘s Center for Drug Evaluation and Research, testified before the U.S. House Energy and Commerce’s health subcommittee that first-cycle drug approvals are at a 20-year high, and more than two-thirds of new treatments are being cleared within the time frames given to new drug applications.

The director also noted the agency approved 20 compounds so far this year, one less than the total for all of 2010, and that the FDA meets more than 90% of drug-review deadlines, according to FirstWord.  

At the hearing, Woodcock fielded questions regarding the FDA’s regulatory process, which some lawmakers suggested “has become less transparent and [has] increased the time it takes for products to reach those who need them.” However, she proposed that challenges being faced by the biotechnology and pharmaceutical industries are related to high failure rates of drugs in development rather than the FDA’s regulations.

OncoMed Pharmaceuticals CEO Paul Hastings, who also testified at the hearing, said “regulatory uncertainty, longer drug development timelines and an increasing regulatory and Congressional focus on risk instead of reward in pharmaceutical innovation deters limited partners from investing in biotech venture capital firms and subsequently deters venture capitalists from investing in biotechnology discovery companies.”


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