GAO Reports That the FDA Fails to Follow Up on Unproven Drugs

The Government Accountability Office (GAO) has proclaimed that the Food and Drug Administration (FDA) should do more to track whether drugs approved based on preliminary results have lived up to their promise.

A report released by the GAO in October 2009 points out that the FDA has never pulled a drug off the market despite a lack of required follow-up of the drug’s actual benefits. Congressional investigators added that the FDA allowed certain cancer and other drugs to stay on the market even when follow-up studies showed that they didn’t extend patient’s lives.

In the case of the low blood pressure drug ProAmatine, for instance, required follow-up studies have remained incomplete for more than 13 years. And the clinical benefit of treatment with the drug has not been established.

Another example is that of the lung cancer drug Iressa, which was approved by the FDA in 2003 based on preliminary results that showed that the drug reduces the size of tumors. Later studies revealed that the medication did not significantly extend patient lives, but the FDA left it on the market despite hundreds of reports of patients who developed pneumonia.

The FDA has responded that the GAO report portrays an overly negative picture of the agency’s "accelerated approval" program, which is used only to approve drugs for the most serious conditions. The program, for instance, has given patients earlier access to HIV drugs based on their ability to increase survival rates.

But the report identifies numerous drugs still on the market that did not live up to their promise. And when pressed about it, FDA officials admitted that they have no plans to get more aggressive.

Dr. Sidney Wolf, of Public Citizen, a consumer advocacy group, said “...this is an area where [the FDA is] basically defending, not enforcing the law.” She adds that the agency’s lax policy sends a message to drug makers that there is no penalty for failing to complete their required follow-up studies.