Report faults FDA follow-up on drugs

The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.

The FDA responded that the report paints an overly negative picture of its so-called accelerated approval program, which is only used to approve drugs for the most serious diseases.

“Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments,’’ thanks to the program, the FDA said in its response to the report.

In 1992, the FDA began speeding up the approval of novel drugs based on so-called surrogate endpoints, or laboratory measures that suggest the drug will make real improvements in patient health.

Drug makers favor the program because it helps them get products to market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars. A condition of quicker approvals is that drug makers conduct follow-up studies to show the benefits actually panned out.

But the GAO report, a copy of which was obtained by the Associated Press, identified several drugs still on the market that never lived up to their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never pulled a drug off the market due to missing or unimpressive follow-up data.

“FDA has fallen far short of where it should be for patient safety,’’ said Senator Charles Grassley, Republican of Iowa, who requested the investigation.

FDA officials say they have overhauled their tracking system since the GAO completed its report. And an outside analysis concluded last month that most companies are meeting their study requirements on time.