Report Finds FDA Lax on Oversight of Doctors During Clinical Trials

According to an investigation conducted by the inspector general of the Department of Health and Human Services, the FDA does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects.  The investigation revealed that in 42 percent of clinical trials, the FDA did not receive the required forms disclosing doctors’ financial conflicts and did nothing about the problem.  In 31 percent of the trials in which the FDA did receive the required conflict forms, agency reviewers did not document that they looked at the information.  And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the FDA nor the sponsoring companies took any action to deal with the conflicts.

This investigation provides further evidence that money doctors routinely collect from drug and device makers may hurt patients and skew studies.