FDA says most Phase IV studies "not started"

The US Food and Drug Administration has issued an annual report which reveals that about 71% of post-approval studies that were "promised" as a condition for the approval of a drug by the agency have not begun and more are "delayed."

Of the 1,259 pending Phase IV studies up to September 20, last year, 899 had not been initiated and 144 had been submitted to the FDA for review or terminated. The remainder consisted of 184 that were classified as either ahead of or on schedule, while 31 were listed as "delayed."

Bill Vaughn, senior policy analyst at the Consumers Union, remarked: "how can the FDA claim it is committed to improving drug safety when it can't even get drugmakers to do the studies that they promise? Should consumers really feel safe when two out of three studies aren't being done and the FDA doesn't even have the authority to get them done?"