The FDA Needs to Pull Failed Drugs From the Market


To get drugs to market faster, the Food and Drug Administration has increasingly allowed drug trials to use “surrogate endpoints,” such as a lab test that might predict an eventual clinical benefit. After the drugs reach market, companies must then perform studies to ensure the drugs actually do provide the intended clinical benefit. If not, the FDA is supposed to rescind approval.

FDA follow-through hasn’t happened, says a study in an American Medical Association journal by Diana Zuckerman and Tracy Rupp, both of the National Center for Health Research, a Washington, D.C.–based think tank.

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