Published 2 November 2009, doi:10.1136/bmj.b4518
Cite this as: BMJ 2009;339:b4518

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US drug agency is slow to exclude doctors who commit research crimes from further trials

Janice Hopkins Tanne

1 New York

The first 150 words of the full text of this article appear below.

The US Food and Drug Administration has taken up to 11 years to debar doctors who engage in misconduct or crimes from participating in research involving new drugs, biologics, and medical devices, shows a report from the US Government Accountability Office.

Among the types of "alleged misconduct" cited by the FDA in its disqualification proceedings are submitting false information to the sponsor or to the FDA; failing to comply with requirements for obtaining informed consent from trial participants; failing to obtain approval from institutional review boards; failing to comply with the clinical trial’s research plan; failing to keep records about the use and disposal of investigational drugs, biologics, or devices; and failing to prepare or maintain case histories or other records.

The report calls on the FDA to "improve its oversight" and says that "the commissioner of the FDA should pursue extending the FDA’s debarment authority; extend disqualification to include . . . [Full text of this article]


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Rx for FDA
Hugh Mann
bmj.com, 11 Nov 2009 [Full text]
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