A Survey of Evidence of Restricted Indications Approved for New Drugs

We reviewed the indications of new drugs approved by the Center for Drug Evaluation and Research, Food and Drug Administration (FDA) between July 1996 and July 2002 and we identified those approved for restricted indications in order to assess the reasons for restricted indications of prescription drugs, which are indications with the specific terms of mild, moderate, severe, mild to moderate, moderate to severe, or moderately severe for disease severity. We analyzed the FDA review reports and labels for these drugs to determine whether the inclusion criteria in their pivotal studies required certain levels of disease severity to be eligible for participation and whether the disease severity was the same as those subsequently approved in the indications. We found that a total of 20 drugs were approved for restricted indications. With the exception for one drug for which there was insufficient public information, all of these drugs required certain levels of disease severity in their pivotal studies and the severity levels were the same as those approved in their indications.