Investigators Say FDA Lax on Doctor Financial Conflicts

Government investigators are saying the U.S. Food and Drug Administration does virtually nothing to police financial conflicts of doctors who head up clinical trials of drugs and medical devices conducted on humans.

Moreover, investigators from the U.S. Department of Health and Human Services say agency officials told them trying isn’t worth it.

In 42 percent of clinical trials, the agency didn’t receive forms disclosing doctors’ financial conflicts and did nothing as a result, according to the investigation, which was led by the inspector general of the Department of Health and Human Services. Results will be public today.

In 31 percent of the trials in which the agency did receive the required forms, agency reviewers did not document that they eyed the information. And in 20 percent of the cases in which doctors revealed major financial conflicts, neither the FDA nor sponsoring companies took action, the investigators found.

Karen Riley, a spokeswoman for the FDA, said the agency opposed reviewing doctors’ financial conflicts before trials because they show just one possible source of bias.