FDA will revise its regulations to prevent clinical investigators who are disqualified from running trials for one product type to continue leading studies for other FDA-regulated categories.

The planned change responds to an Oct. 22 report from the Government Accountability Office that points out a loophole in the current regulations, whereby an investigator who is disqualified from serving as a primary investigator for drug or biologic trials is still allowed to be the primary investigator for device trials, and vice versa.

"FDA agrees that if a clinical investigator is disqualified from participating in clinical trials involving one type of investigational article (e.g., drugs), it is generally appropriate that the investigator be prohibited from participating in investigations of any FDA-regulated product," the agency writes in its response to GAO's report.

"The agency intends to pursue revisions of its regulations concerning clinical investigator disqualification to effect this change," FDA says.

The agency can disqualify an investigator from receiving investigational drugs, biologics or devices if the researcher repeatedly or deliberately fails to comply with pertinent regulations or submits false information to FDA or a sponsor. A disqualification bars an investigator from leading trials in the targeted product class, but does not necessarily prevent lower-level involvement in trials.

For drug and biologic trials, FDA can go a step further in cases when the researcher has been convicted of a crime relating to drug/biologic research. In those instances, the agency can either temporarily or permanently "debar" the investigator from contracting in any way with a drug or biologic product sponsor. FDA does not have the same authority for medical device investigators, which GAO points to as a significant gap.

"An individual may be debarred from involvement with drugs and biologics, but not from involvement with medical devices, regardless of the kind of misconduct in which the individual engaged," the report laments.

In its response, FDA agrees that expanding debarment authority "would benefit the development and approval process for medical devices." But such expanded authority would require new legislation.

Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, has signaled interest in pursuing such legislation. It was Barton and Rep. Greg Walden, R-Ore., ranking member of the Energy and Commerce Oversight and Investigations Subcommittee, who requested the GAO inquiry.

The report also points to significant delays in many disqualification and debarment proceedings. The critiques come as FDA is in the midst of making procedural changes to how it pursues these remedial measures, such as specifying internal timelines that have to be met for different stages of the proceedings.

In August, FDA announced that it was making significant progress in improving the efficiency of disqualification and disbarment (Also see "FDA Will Move Faster To Ban Bad Actors From Clinical Trials" - Medtech Insight, 17 August, 2009.). GAO acknowledged the reforms, but cautioned that "the full effect of these changes remains to be seen."

The report notes that the new FDA timeframes for debarment and disqualification are significantly shorter than they were previously and questions whether the agency will have the resources to maintain the improvements for the long term.

Final "Investigator Responsibility" Guidance Issued

In response to the GAO investigation, FDA also cited efforts to reach out to investigators and other clinical trial stakeholders to explain regulatory requirements. The agency says it is drafting guidance to explain the disqualification process.

Coincidentally, FDA issued a final guidance Oct. 26 describing investigator responsibilities under the regulations in protecting the "rights, safety and welfare" of human study subjects for device, drug and biologics trials.

- David Filmore (d.filmore@elsevier.com)

[Editor's note: This story appears courtesy of the editorial staff of 'The Gray Sheet,' your source for coverage of devices and diagnostics. For a sample copy, call customer service at 800-332-2181.]

FDA Will Revise Investigator Disqualification Regs In Response To GAO Report

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