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    71% of all post-approval studies are still “pending,” (and haven’t even started yet) says FDA

    Feb. 2, 2007
    According to a report published on Friday by Bloomberg News, drug makers have yet to begin more than two out of every three of the safety studies that are supposed to conduct, once FDA has approved their products.  FDA estimates that 899 of 1,259 post-approval studies hadn't been started as of Sept. 30, according to data posted Thursday on the agency's Website and reported by Bloomberg. The numbers do not include completed studies. FDA's approval of new drugs often stipulates that drug makers perform additional safety, dosing and other tests after medications come to market. Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use, the Bloomberg report said. Bloomberg also noted that several members of Congress  (particularly Senator Grassley) have criticized the FDA's oversight of drug safety, citing problems with antidepressants and painkillers, such as Vioxx, that can increase the risk of heart attack. Bloomberg News had reported last year that FDA records on the status of some post-approval studies appeared incorrect. In other cases, drug makers failed to keep promises they made to do the research. According to the Bloomberg article citing the FDA statistics released Thursday, 184 studies were on or ahead of schedule, and 144 had been submitted for FDA review or terminated. Thirty-one studies were labeled as "delayed." The FDA reportedly didn't specify the number of drugs covered by the studies or over what time period the studies had been requested. Drug makers sometimes agree to complete multiple studies for a single product. Not all of the uninitiated studies are considered late by the FDA. Many don't have deadlines imposed by regulators. The FDA and drug makers sometimes spend months discussing the design of the studies before they can begin. The FDA's annual report on outstanding post-approval studies didn't identify specific companies. FDA outlined its plans to respond in the following: http://www.fda.gov/oc/reports/iom013007.html The Agency is dedicating the following resources to this issue: http://www.fda.gov/oc/factsheets/drugsafety-iom.html
    According to a report published on Friday by Bloomberg News, drug makers have yet to begin more than two out of every three of the safety studies that are supposed to conduct, once FDA has approved their products.  FDA estimates that 899 of 1,259 post-approval studies hadn't been started as of Sept. 30, according to data posted Thursday on the agency's Website and reported by Bloomberg. The numbers do not include completed studies. FDA's approval of new drugs often stipulates that drug makers perform additional safety, dosing and other tests after medications come to market. Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use, the Bloomberg report said. Bloomberg also noted that several members of Congress  (particularly Senator Grassley) have criticized the FDA's oversight of drug safety, citing problems with antidepressants and painkillers, such as Vioxx, that can increase the risk of heart attack. Bloomberg News had reported last year that FDA records on the status of some post-approval studies appeared incorrect. In other cases, drug makers failed to keep promises they made to do the research. According to the Bloomberg article citing the FDA statistics released Thursday, 184 studies were on or ahead of schedule, and 144 had been submitted for FDA review or terminated. Thirty-one studies were labeled as "delayed." The FDA reportedly didn't specify the number of drugs covered by the studies or over what time period the studies had been requested. Drug makers sometimes agree to complete multiple studies for a single product. Not all of the uninitiated studies are considered late by the FDA. Many don't have deadlines imposed by regulators. The FDA and drug makers sometimes spend months discussing the design of the studies before they can begin. The FDA's annual report on outstanding post-approval studies didn't identify specific companies. FDA outlined its plans to respond in the following: http://www.fda.gov/oc/reports/iom013007.html The Agency is dedicating the following resources to this issue: http://www.fda.gov/oc/factsheets/drugsafety-iom.html
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