Doctors `Repeatedly or Deliberately' Break FDA Drug-Trial Rules

[Roland99]

Source: Bloomberg

Feb. 29 (Bloomberg) -- James C. Vestal, a Texas urologist, exposed his patients to ``unnecessary risk'' and ``submitted false information in required reports'' during the clinical trial of a prostate cancer drug, according to the U.S. Food and Drug Administration.

The agency's drug division ``believes that you repeatedly or deliberately violated regulations governing the proper conduct of clinical studies,'' the FDA said in a letter to Vestal. ``Accordingly, FDA proposes that you be disqualified as a clinical investigator.''

The FDA didn't send the letter starting disciplinary action against Vestal until May 2007, more than three years after his violations of agency rules were detailed in reports by the FDA's own staff investigators. Vestal continued to conduct drug trials as recently as last year, as he was permitted to do. He has stopped voluntarily while negotiating with the FDA on his case.

The agency has failed to complete disciplinary action against 12 researchers, including Vestal, after proposing that they be disqualified from trials based on findings that they violated rules designed to protect patients and ensure accurate data, FDA records show. Cases have remained unresolved for as long as a decade.

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