FDA Approves More New Drugs In 2008

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FDA approved 24 new drugs in 2008, more than in any of the prior three years, the Wall Street Journal reports. The agency approved 18 drugs in 2007, 22 in 2006 and 20 in 2005. According to the Journal, the agency's high 2008 approval rate is "a consolation of sorts to an industry struggling with greater scrutiny, thousands of layoffs and thinning drug pipelines."

A standard drug review takes 10 months, while a priority review takes six months and is given to drugs FDA deems are an advance over existing treatments. FDA does not have a goal for the number of drugs approved each year, according to agency spokesperson Sandy Walsh. She said it is difficult to compare one year's figures to another because applications are received on a rolling basis. "The primary factor driving new drug approval is the quality of the application and the data that support the drug's safety and efficacy," she said.

Year of Delays

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Industry analysts say that despite the high rate of approvals, 2008 will be remembered more for delays in the approval process. FDA sets a goal of reaching a final decision on 90% of applications within the six- to 10-month time frame. However, FDA said it missed deadlines on 32 out of 159 drug applications, or 20%, through Oct. 31, 2008.

John Jenkins, director of FDA's office of new drugs, recently told an industry conference that the agency has "been struggling to meet (drug approval) goals for the past several years" and made a "management decision" earlier last year that it could not meet all of its deadlines given the workload and a staff shortage. According to the Journal, one factor contributing to the missed deadlines is a requirement that all new drug applications be reviewed by agency advisory committees made up of outside medical experts.

Jenkins said that the agency in 2008 hired more than 800 employees, but added that training the new employees has taken time. Jenkins said that in 2009 the agency hopes to come closer to its 90% goal. Ira Loss, a senior health care analyst at Washington Analysis, said that the new employees should improve the speed of the agency's approval process by mid-2009 (Favole/Corbett Dooren, Wall Street Journal, 1/2).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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