FDA Lax on Drug Follow-Up Studies: GAO
The use of several drugs to treat cancer and other conditions has been allowed to continue even though follow-up studies showed they didn't extend patients' lives, says a U.S. Government Accountability Office report to be released Monday.
The GAO also said that the Food and Drug Administration has never ordered a company to take a drug off the market because promised follow-up studies about the drug's benefits haven't been completed. In some cases, that follow-up information is more than a decade overdue, the Associated Press reported.
The FDA also needs to do more to monitor whether drugs approved under its so-called "accelerated approval" program actually fulfill their promise, the GAO said. The accelerated approval program is designed to speed availability of treatments for the most serious diseases.
The GAO said that since 1992, the FDA has requested follow-up 144 studies of drugs approved under the program, but only 64 percent have been completed and more than one-third are still pending, the AP reported.
The GAO report presents an overly-negative assessment of the program and there are no plans to get more aggressive about follow-up, according to the FDA.
"Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments," through the accelerated approval program, the agency said, the AP reported.
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