WASHINGTON – In a report released today, the Government Accountability Office found that the Food and Drug Administration often took four years to ban researchers whose studies had been tainted by their illegal actions and professional misconduct, with one case consuming nearly 11 years before the doctor was “debarred.” The report also found that FDA lacks any authority to debar investigators who broke the law while researching medical devices.
“GAO is Congress’s watchdog and I had asked them to start digging into this as soon as possible. We needed to understand what had gone haywire with the system and how FDA could rapidly detect and remove the clinical investigators who engage in misconduct during drug trials,” said U.S. Rep. Joe Barton of Texas, ranking Republican of the House Energy and Commerce Committee. “The FDA had failed to make its debarment authority work, and now the GAO report offers the latest details of a record of the agency’s weakness and failures. I think it is especially inexcusable that the agency can’t seem to quickly and consistently debar even convicted felons.”
The notorious example is Dr. Anne Kirkman-Campbell, an Alabama physician who participated in clinical trials of an antibiotic that produced liver failure after it was approved. Dr. Kirkman-Campbell’s data were audited and she eventually was prosecuted for mail fraud. She pleaded guilty in 2003 and went to prison, but the FDA did not ban her from taking part in drug tests until Sept. 2, 2008.
Among the findings:
o More than half of the 18 debarment proceedings FDA has initiated since receiving debarment authority took four or more years to complete.
o The time FDA takes to complete disqualification varies widely, from 26 days to more than 10 years, with a median of 1.1 years.
o GAO found that FDA lacked systemic procedures to help ensure communication of conviction information so that proceedings could be started or establish timeframes.
o Debarred individuals are prohibited from involvement with drugs and biologics — but not from working or serving in any capacity for a medical device company, or for any other FDA-regulated product, such as a cosmetic company.
o Under federal regulations, a clinical investigator who is disqualified for misconduct relating to drugs or biologics is still able to serve as an investigator for devices. Similarly, an investigator disqualified for misconduct for devices can still serve as an investigator for drug and biologic studies.
o Because FDA’s disqualification authority is not across-the-board, but product specific, one disqualified investigator for drugs and biologics — who had falsely reported that infants had been vaccinated when they had not, and also failed to report that study participants had been hospitalized — can still serve as an investigator for medical devices or other FDA-regulated products.
“The problems at FDA are daunting, but I think that a little common sense and some modest legislating can ensure that American families will be safe. The bill that I will be introducing will require FDA to bring debarment actions within one year of the date of conviction,” Barton added. “It also will close the gaps in the debarment statute so that FDA has authority not just over misconduct that takes place during a drug or device’s development or approval, but over all misconduct relating to the drug or device.”
A copy of the GAO report on FDA debarment can be found here.
