FDA Rejects More New Medications This Year Than In 2006 As Agency Faces Scrutiny Over Drug Safety
August 24th, 2007 by 
Barry - Admin BioPharmArena
FDA in recent months has rejected a “slew” of new drug applications or delayed approval of experimental medications and required more data, as the agency faces increasing concern over drug safety since the painkiller Vioxx was pulled from the market in 2004, the AP/Baltimore Sun reports. FDA this year has approved 61% of new drug applications through mid-August, compared with 73% during the same period last year.
The AP/Sun reports that the increased rejections have affected patients’ access to new medications, hurt drug manufacturers stock prices and are expected to increase the time and cost of developing new and future medications. Steve Brozak, an analyst with WBB Securities, said, “The FDA is being more cautious” because it realizes that new medications will be used off-label, which can increase the risk of serious side effects. Brozak said the agency’s mentality now is that it has “got to be so safe that we’re not going to be criticized ever” for approving the drug.
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