US GAO calls for faster FDA action to debar disqualified investigators

Following a request to the USA's Government Accountability office to review the Food and Drug Administration's debarment and disqualification processes, it has reached the conclusions that the agency is slow to debar health professionals who have been convicted of crimes from doing research for the agency or overseeing the safety of patients in clinical trials, according to the government watchdog's report released Thursday.

More than half of the debarment proceedings in GAO's review took four or more years, and factors contributing to these time frames included internal control weaknesses in the debarment process and competing priorities among responsible staff. In one instance, it took the FDA 11 years to debar a doctor who had been convicted of 53 counts of criminal offense for, among other things, bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license.

The FDA has the authority to bar doctors from overseeing the safety of patients in clinical trials if those health professional flout federal regulations. The agency is required to disqualify doctors who are convicted of fraud or other crimes. However, it takes the agency an average of four years to strip doctors of their powers, according to the GAO report.

The FDA made changes to its disqualification process (eg, by establishing time frames in June 2008 and January 2009) that could further improve timeliness, but the full effect of these changes remains to be seen, the GAO stated.
Types of misconduct that can get doctors debarred include submitting false information to the FDA, forging patient consent forms and not reporting when a patient has an adverse reaction to an experimental drug.

The report also shows that, even when the FDA bars a doctor from participating in a clinical trial for a drug, that person can still oversee patients in experimental trials that involve medical devices. The process also works the other way: Moreover, a doctor barred from overseeing trials involving medical devices can still participate in drug trials.

Further, the FDA does not have the authority to debar doctors, regardless of their misconduct, from participating in any form of the medical-device industry. The report says a health professional who was convicted of falsely advertising a laser device for treating eye disorders can't be debarred.

In its conclusion, the GAO recommended that the Commissioner of FDA should take the necessary steps to pursue debarment authority for medical devices that is consistent with the current debarment authority for drugs and biologics and prohibit any debarred individual from involvement with drugs, biologics, and medical devices.

Bill to close loop hole proposed

It is this loop hole, and the FDA's slow response, that Republican Representative Joe Barton of Texas hopes to close with a proposed bill that would require the agency to debar doctors within one year of them being convicted of a crime or found committing fraud, reports the Wall Street Journal.

"I think it is especially inexcusable that the agency can't seem to quickly and consistently debar even convicted felons," Rep Barton said in a press release. He highlighted what he calls a "notorious" case. It took the FDA about five years to debar Anne Kirkman-Campbell, an Alabama physician who pled guilty to mail fraud and was sentenced to more than four years in jail related to a clinical trial for French drug major Sanofi-Aventis' antibiotic, Ketek.