Summary: Testimony was given concerning a GAO review of the clinical testing of anticancer drugs and the regulation of that testing by the Food and Drug Administration (FDA). The review was conducted in response to congressional interest in the adequacy of existing policy, practices, and procedures within the Department of Health and Human Services (HHS) with respect to the protection of individuals who participate in federally sponsored trials of investigational new drugs (IND's). GAO stated that FDA and the National Cancer Institute (NCI) are making improvements in ensuring that patients involved in the clinical testing of anticancer drugs are protected. However, GAO did identify problems in that: (1) FDA has no followup system to ensure that IND sponsors address its recommendations; (2) FDA does not always receive from sponsors, or promptly review, IND amendments; (3) clinical investigators and drug sponsors do not always promptly report adverse drug reactions; and (4) FDA and NCI need to improve monitoring of clinical testing. GAO is making a number of proposals to the Secretary of HHS to address these and other problems associated with the protection of patients during testing.
