Recent action by the Food and Drug Administration to step up efforts to ban noncompliant medical researchers from participating in future clinical trials may not have provided enough assurance to lawmakers.
No dillydallying: Barton
Proposed legislation in response to GAO report on FDA's slow debarment
Late last week, following the release of a critical Government Accountability Office report that found the FDA has done a poor job of taking debarment actions against rule-breaking researchers, Rep. Joe Barton (R-Texas) said he planned to introduce a bill that would require more timely debarment of noncompliant medical investigators.
Details of the proposed legislation were not yet available, but a Republican aide for the House Energy and Commerce Committee said that Barton—the ranking committee member who requested the GAO investigation—planned to introduce the bill within the next two weeks.
“The problems at the FDA are daunting, but I think that a little common sense and some modest legislating can ensure that American families will be safe,” said Barton in a written statement reacting to the GAO report.
According to the report’s findings, more than half of the 18 debarment proceedings that the FDA initiated since receiving authority in 1992 to ban researchers took four or more years to complete. In one case, the agency took 11 years to debar Alabama physician Anne Kirkman-Campbell even though she was convicted and sentenced to five years in jail for fudging data in an antibiotic drug trial.
While the FDA declined to comment on the GAO report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Products Investigators, the FDA acknowledged in a written statement preceding the findings’ release that an internal investigation had concluded the agency needed to revamp and improve its debarment procedures. “Some members of Congress have expressed concern that the FDA has not adequately used its disbarment and disqualification authorities,” wrote FDA officials in an August news release.
Responding to those concerns, as well as charges that when the FDA did invoke its debarment authority it was often slow to remove violating researchers from the drug or development process, officials said the agency had taken steps to centralize the coordination of debarment activities and increase the size of its research-protocol enforcement staff.
But improved use of existing powers may get the FDA just so far in its efforts to weed out offending medical product researchers. According to the GAO report findings, even in cases where the FDA has initiated timely debarment proceedings, the agency has often lacked power to fully prohibit criminal and noncompliant drug researchers from participating in future medical-products research. That’s because the FDA’s current banning powers do not extend to medical devices and all types of drug research.
“It’s really an anomaly in the law that it doesn’t cover medical devices and that drug company disbarment is only for generic firms and not brand-name drugmakers,” said a second Republican aide with the House Energy and Commerce Committee. According to that aide, the current law was passed in 1992 in response to misconduct in generic drug trials. As a result, the FDA has never been fully empowered to bar any and all researchers convicted of breaking rules. Nor is it able, under current law, to prevent banned drug researchers from conducting medical-device research.
Barton has said his bill would close the gap and grant the agency authority to debar researchers who engage in misconduct when developing or conducting a clinical trial for a drug or medical device.
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