The U.S. Food and Drug Administration (FDA) has been lax in its oversight of clinical trials and does not do an adequate job of protecting patients, according to a federal report released today.
Companies that want to sell a new drug first have to show it is safe and effective in clinical trials. FDA is supposed to oversee these trials to ensure that companies and other sponsors are following the agency's regulations, especially when it comes to limiting risks to patients. Concerned that this wasn't happening, Senator Chuck Grassley (R-IA) commissioned a report from the Department of Health and Human Services (HHS) 2 years ago.
FDA isn't taking a wide look at trials, the report concludes. The 41-page assessment finds that from 2000 to 2005, FDA conducted 2856 inspections, which apparently covered only 1% of clinical trial sites. One problem identified in the report is that FDA doesn't maintain a database of all ongoing trials or a registry of the ethics review boards that oversee the protection of volunteers in trials. In addition, the agency center that handles new drug reviews often concludes that any violations are less serious than inspectors said they were, according to the report. And officials seldom follow up to make sure institutions respond to problems such as poor record-keeping or failing to follow the approved protocol. FDA's inspections also tend to focus on checking the quality of data from completed trials rather than making sure human subjects are being treated well in ongoing trials, the report says.
FDA said in a statement that the report "offers valuable insight" and that it is already following up on the report's five recommendations. Those include creating a comprehensive internal trials database and a registry of ethics review boards. Senator Grassley, who described the report as "troubling," has asked FDA staff to report to him on its efforts.
But some observers doubt those efforts will go anywhere. HHS has issued similar reports since 1998 and nothing's changed, says Peter Lurie, deputy director of Public Citizen's Health Research Group in Washington, D.C.: "We've heard all this before." And although bioethicist Mary Faith Marshall of the University of Minnesota, Minneapolis, says she's optimistic that the registry of ethics review boards will be completed soon, she agrees that the political appointees in charge of FDA seem unwilling to make significant changes.