GAO Faults FDA For Failing To Follow Up On Unproven Drugs

The AP has reported that the FDA "has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives" or the makers did not perform follow-up studies. The report goes on to criticize the FDA's "so-called 'accelerated approval' program, which is only used to approve drugs for the most serious diseases." The program allows drugmakers to bring products to market sooner under the condition that they conduct follow-up studies. The GAO "identified several drugs still on the market that never lived up to their initial promise" and noted that in the program's 16 years the agency "never once pulled a drug off the market due to missing or unimpressive follow-up data." The FDA reports that it has "overhauled [its] tracking system since the GAO completed its report." Principal Deputy Commissioner Dr. Joshua Sharfstein said that the FDA does not have a policy for pulling the drugs off the market because "we don't want to lock ourselves into a specific set of criteria." He "added that the agency has a task force assigned to look at policies like drug withdrawals."

Art Kosieradzki