GAO Faults FDA Over Lax Follow-Up On Drug Studies

The Government Accountability Office and the Food and Drug Administration are at it again.

A report from GAO scolds FDA for not following up on studies for some drugs that get approved after data suggest they are effective on a marker that stands in for the course of disease.

This accelerated approval process, established for drugs treating serious illnesses like cancer and HIV/AIDS, is supposed to move medicines along that could save or extend patients' lives. The catch is that these drugs are then supposed to go through "postmarketing studies" to confirm the drugs are safe and effective, so they can stay on the market.

 

Since 1992, FDA has approved 90 applications for drugs this way, bypassing the normal process. But GAO says post-marketing studies were only completed for two-thirds of the quickly approved drugs, and none were pulled from the market.

GAO recommends FDA clarify when it would revoke an approval, so companies have a stronger incentive to finish the studies.

FDA defends its approach, arguing the GAO report downplays the success of the program, which provides patients with new drug treatments sooner than would otherwise be possible. Plus, the testing is a lot more complicated than GAO make it out to be.

They say a blanket process for pulling drugs off the market wouldn't work. For instance, a couple of the drugs mentioned in the report that never finished postmarketing studies are the only drugs on the market for the condition they treat, or they only show positive effects in certain patients, even if they don't work for everyone.

Chalk the squabble up to the seemingly endless back and forth between the regulator and its overseers. In 2006, a very similar report was released by GAO, also requested by Republican Senator Chuck Grassley of Iowa. That one focused on postmarket studies for drugs approved the usual way and came to similar conclusions.