Reports shed light on FDA oversight problems

When we talk about FDA oversight, what might we mean? Not too much, according to a pair of new reports from the Office of the Inspector General in the Department of Health and Human Services.

One report assessed the process by the FDA’s Center for Drug Evaluation and Research for selecting information technology contractors and monitoring their performance between fiscal years 2004 and 2007. The findings: CDER’s actions demonstrated “limited IT planning and increased risk for the government” by using broad language and relying primarily on acquisition methods that emphasize speed and flexibility over planning. CDER also used quality assurance and monitoring plans inconsistently. For instance, 21 of 28 ‘contract actions’ didn’t have documented quality assurance plans. And of seven contract actions that did include quality assurance plans, three contained identical plans with generic language, no pun intended, for inspections.

A second report, which got some notice earlier this week, found that oversight was lacking of financial conflicts of interest involving clinical trial investigators. For instance, only one percent disclosed at least one financial interest, and this represented 206 of the 29,691 investigators listed in financial interest forms. Of the 206, almost all disclosed only one financial interest, with a few disclosing two or three.

A few other problems – the FDA can’t determine whether sponsors have submitted financial info for all clinical investigators; 42 percent of FDA-approved marketing applications were missing financial info; the FDA didn’t document a review of any financial info for 31 percent of marketing applications, and neither the agency or sponsoring drug makers took action for 20 percent of marketing applications with disclosed financial interests. And when the FDA did action, the agency was inconsistent.

And how did the FDA respond? The agency told the OIG that the extra effort to collect such info “would not be worthwhile because financial interests are only one form of potential bias and not all clinical trials are presented in the marketing applications. That may be true, but the FDA is slow to realize that bias among investigators similarly may pose perceived or real problems.

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