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Report: FDA lax on potential financial conflicts of interest

January 13, 2009 by  

The FDA does not properly explore financial tiesJust days after scientists within the FDA accused managers in the administration of corrupt practices, a new report raises concerns about disclosure of financial conflicts.

According to the Health and Human Service Department’s inspector general, 42 percent of marketing applications approved by the FDA did not contain required information about any financial connections between companies and researchers.

Without this documentation, it would be impossible to determine if there was a financial conflict of interest in a clinical trial.

The FDA has required financial documentation of this type for nearly a decade, but the report reveals that compliance with this requirement has been lax.

In 31 percent of applications reviewed, the agency did not document that it had reviewed any financial data at all.

Meanwhile, in 20 percent of applications that contained disclosures that may have raised questions, the FDA did not act, according to the report.

The inspector general made a number of recommendations for improvement to the process. The FDA accepted all but one, which suggested it should investigate conflicts of interest before a trial even began.

The agency said this would add to its workload without producing meaningful results for the public.
ADNFCR-1961-ID-18971674-ADNFCR

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