Prescription drugmakers have failed to begin 71% of the post-marketing studies which they had promised to the US Food and Drug Administration (FDA) as a condition of getting a treatment approved, the agency has reported.
As of September 30, 2006, 899 out of 1,259 pledged post-approval studies had not commenced, says the FDA. Of the studies that had started by that date, 184 were on or ahead of schedule, 144 had been submitted to the agency for review or been terminated and 31 were “delayed.”
However, the FDA does not consider all of the 899 studies which have yet to start as being late, as discussions on study design between the agency and manufacturers can be lengthy, comments Bloomberg. Also, the report does not indicate the number of products covered by the studies, nor specify the time period over which they were requested, it adds.
Post-marketing studies are voluntary, and the advocacy group Consumers Union (CU) has condemned the fact that the FDA does not have to authority to require them to be carried out. “The fact that drugmakers are ignoring their own promises to perform safety studies shows how desperately we need stronger laws to protect the public,” said CU senior policy analyst Bill Vaughan. “Drugmakers are getting away with a wink and a nod when it comes to these promised studies, and that is simply not right,” he added. Lynne Taylor
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