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Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators

GAO-09-807 Published: Sep 25, 2009. Publicly Released: Oct 22, 2009.
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The Food and Drug Administration (FDA) oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. GAO was asked to review FDA's debarment and disqualification processes. GAO examined the length of time debarment and disqualification processes have taken and factors for those time frames, and the statutory and regulatory limitations of debarment and disqualification. GAO reviewed laws, regulations, and FDA files through November 5, 2008, for (1) all investigators, study coordinators, and sub-investigators for whom FDA pursued debarment since receiving debarment authority in 1992; and (2) all clinical investigators for whom FDA pursued disqualification since FDA adopted its current process for initiating proceedings in 1998.


Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 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.
Closed – Not Implemented
In its written comments on a draft of our report, FDA indicated that having debarment authority to prohibit individuals and companies convicted of certain crimes, or otherwise involved in criminal activity, from involvement in the medical device industry would benefit the development and approval process for medical devices. FDA subsequently confirmed its support for extending its debarment authority to include persons involved in the medical device industry. A bill that would grant FDA this authority was introduced and referred to the House Committee on Energy and Commerce, Subcommittee on Health, in October, 2009, but was not enacted. In July 2013, the agency reported that it has taken no further action on this recommendation and suggested that we close it. Given that implementation of this recommendation seems unlikely, we are closing it as not implemented.
Food and Drug Administration The Commissioner of FDA should take the necessary steps to amend FDA regulations to ensure that those who have engaged in misconduct found sufficiently serious to warrant disqualification for one investigational medical product are not able to continue to serve as clinical investigators for any.
Closed – Implemented
On April 30, 2012, FDA issued a final rule amending the regulations to expand the scope of clinical investigator disqualification. Under this rule, when the Commissioner of FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator will also be ineligible to conduct any clinical investigation that supports an application for research or marketing permit for other kinds of products regulated by FDA. When it issued this final rule, FDA stated that the rule is based in part upon GAO's recommendation. Amending its regulations to expand the scope of investigator disqualification is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA.
Food and Drug Administration The Commissioner of FDA should take the necessary steps to monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.
Closed – Implemented
FDA agreed with GAO's recommendation and took steps to implement it, including establishment of procedural requirements, development of tracking systems, and issuance of guidance. In addition, FDA has monitored the timeliness of debarment and disqualification proceedings and taken actions when steps are not completed in a timely way. Timely completion of these proceedings is critical to ensuring that individuals who have engaged in misconduct are prohibited from repeating the misconduct--that is, the actions that compromised the quality or integrity of clinical trial data or jeopardized the safety of clinical trial participants--and that individuals whose explanations FDA finds to be satisfactory can have their proceedings concluded quickly.

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