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Medical News & Perspectives |

Report: FDA Exerts Too Little Oversight of Researchers’ Conflicts of Interest

Bridget M. Kuehn
JAMA. 2009;301(7):709-710. doi:10.1001/jama.2009.127.
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The US Food and Drug Administration (FDA) is doing too little to identify and mitigate the impact of financial conflicts of interest among researchers who conduct clinical trials of experimental drugs, biologics, and medical devices, according to a report released in January by the Department of Health and Human Services' Office of Inspector General (OIG).

Despite a 1999 regulation that requires a drug or device manufacturer to disclose the financial interests of clinical trial investigators when the company submits an application to market a product, nearly 42% of the 118 applications approved by the FDA in 2007 lacked complete financial information, the report said (http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf). Even when such information was disclosed, FDA reviewers often did not document that they had investigated the potential impact of such conflicts on trial data. Furthermore, in 20% of cases where a potential financial conflict of interest was identified, neither FDA officials nor trial sponsors took any corrective action; in nearly 70% of such cases only the sponsor took action, and in the remaining cases either the FDA or both the agency and the sponsor took action.

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Potential conflicts of interest by clinical trial investigators were disclosed in 49 marketing applications for new drugs or devices approved by the Food and Drug Administration in 2007. However, only the agency (not the sponsoring manufacturer) took action in 12% of cases, only the sponsor took action in 67% of cases, and neither took action in 20% of cases.



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