Missing information, loopholes, and weak oversight hamper efforts to uncover potential financial conflicts by researchers who test experimental drugs before companies seek US Food and Drug Administration government approval, says a report from the Health and Human Services inspector general’s office said in a report released January 12 .
‘We found a number of limitations in FDA’s oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators,’ the report said. Investigators examined 118 new drug applications approved by the FDA in 2007.
Among the findings:
- The FDA cannot determine whether sponsors have submitted complete financial information for all clinical investigators because it does not have a complete list of clinical investigators.
- In all, 42 percent of the applications lacked complete financial information.
- Less than one percent of researchers disclosed possible conflicts.
- FDA did not document a review of any financial information for 31% of marketing applicatons.
- Neither FDA or sponsors took action for 20% of marketing applications with disclosed financial interests.
According to the report, the FDA acknowledge the need for improvements. However, they also disagreed with some of the inspector general’s findings and recommendations.
Release Date: January 12, 2009
Source: Health and Human Services Inspector General’s Office
Filed Under: Drug Discovery
