Controversy erupts between US Department of Health & Human Services and FDA over missing financial data

On Monday, January 14, 2009, the U.S. Department of Health & Human Services (HHS) published a scathing review of its investigation into the FDA’s oversight of physicians overseeing clinical trials and the sponsoring drug manufacturers in hopes of detecting financial conflicts of interest often disguised as consultant fees, educational grants, or gifts.  Key findings of Monday’s study showed:

 

·                    Only 1% of investigators have disclosed a financial interest;

·                    An estimated 42% of FDA approved marketing applications were missing financial disclosures;

·                    As financial conflicts were discovered in approximately 20% of the applications, the FDA reviewers did nothing to address the problem;

 

The HHS is recommending that the FDA implement strict guidelines at the pretrial application process to address and reduce the industry-wide problem.

 

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