FDA Proposes Rule to Expand the Scope of Disqualification for Clinical Investigators

by admin on June 10, 2011

FDA Proposes Rule to Expand the Scope of Disqualification for Clinical Investigators

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Home Page > Law > Health and Safety > FDA Proposes Rule to Expand the Scope of Disqualification for Clinical Investigators

FDA Proposes Rule to Expand the Scope of Disqualification for Clinical Investigators

Posted: Jun 08, 2011 |Comments: 0
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The FDA requires marketing and research permits for (among other things) drugs, biologics, devices, and new animal drugs.  As a part of the review of those applications the FDA inspects the records of clinical investigators to (1) evaluate the quality and integrity of clinical data relied upon in the application, and (2) ensure that research participants were afforded protections where necessary.  The FDA will disqualify investigators that repeatedly or deliberately either fail to comply with applicable FDA requirements or submit false information in their reports. After disqualification, the investigator can no longer “receive the particular type of test article under study when the violations occurred.”

A proposed rule would create harsher disqualification guidelines for clinical investigators by disqualifying an investigator from receiving all types of test articles and conducting all clinical trials, even when the FDA has only disqualified the investigator from receiving a single, specific-type of test article.

Under the current regulations, an investigator disqualified from receiving a specific type of test article could still receive other types of test articles.  For example, an investigator disqualified from receiving investigational drugs may still receive investigational devices.  The proposed rule would eliminate article-specific disqualification; an investigator disqualified from receiving any test article would be disqualified from receiving all test articles.  The investigator would also be disqualified from conducting clinical investigations in support of a permit application.

The proposed regulation stems from a 2009 report from the Government Accountability Office (“GAO”).  In that report the GAO recommended the type of full investigator disqualification proposed by the rule. The GAO recognized that in many cases the FDA was achieving the result intended by the proposed rule through consent agreements with investigators, but concluded that the authority to unilaterally disqualify investigators from receiving all test articles was necessary to the FDA’s oversight.   The FDA admitted that it has little evidence showing investigators disqualified as to one type of test article were actually conducting investigations studying a different type of test article. Nonetheless, the FDA agreed with the GAO’s rationale and adopted its recommendation.  Interested parties can read the proposed rule in its entirety and submit comments at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0079-0001.


About the Author:
As a skillful computer analyst, Johndel Clay is also a part-time writer for Amin Talati Law Firm. He writes articles about FDA, FTC and patent lawyer.
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