Report: FDA lax in clinical trial oversight

A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Services, has released a report slamming the FDA's oversight of the trials. The FDA has 350,000 testing sites but only 200 inspectors, some of whom work part time. The inspectors managed to visit less that 1 percent of testing sites. When problems were found at the sites, they were often overlooked by top FDA officials and the FDA rarely followed up with those that were cited for problems. One expert interviewed by the New York Times noted that animal testing has more stringent oversight than human testing in the U.S.

The OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards. It also lacks a comprehensive database for tracking its inspections of clinical trials. "Data limitations hinder the FDA's ability to ensure that participants are protected from unreasonable risks," said Levinson. Janet Woodcock [1], director of the Center for Drug Evaluation and Research, acknowledged there problems with the inspection process and that the FDA is working to address them.

- see the OIG's release [2] on the FDA
- read this article [3] for more

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