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More Corporate Scofflaws – Drug Companies Not Reporting Results of Clinical Trials

According to Section 801 of the Food and Drug Administration Amendments Act (better known as  “FDAAA 801”), clinical trials on new medications and medical devices must be reported to the federal registry at  ClinicalTrials.gov within twelve months of completion, or face “civil monetary penalties and, for federally funded studies, the withholding of grant funds”. Those “monetary penalties,” assessed thirty days after the sponsor of the study in question receives notification, are $10,000 a day until compliance.

The law even allows sponsors to request extensions for “good cause,” but since the law went into effect, less than 16% of these studies had submitted a request for an extension.

So...why is there so little compliance?

According to research published in the New England Journal of Medicine (NEJM) only 13.4% of “non-exempt” clinical trials were reported within the one year period mandated by federal law. Interestingly, studies funded by private industry were better in this regard than those getting their funding from the federal government through the National Institutes of Health (NIH), academic institutions, or other government sources. However, a greater percentage of industry-funded studies were exempt from reporting requirements (such as certain Phase 1 trials or behavioral studies). Furthermore, compliance among privately funded trials dropped off significantly after five years.

What's even more shocking (but not surprising) is that the penalties specified by the law have never been imposed on violators.

The law was put into effect to address “public concern that sponsors and investigators were selectively publishing trials that favored the interests of the sponsors and that journals were selectively reporting positive findings.” This is no surprise; a significant number of injury lawsuits over defective prescription drugs and medical devices allege that important information on “adverse events” were not made public. The authors of the NEJM report were also not surprised to discover that

earlier-phase trials were consistently the least likely to report results in a timely fashion, raising concerns that earlier-phase trials are primarily focused on proof-of-concept demonstrations and as such represent valuable, closely guarded intellectual property.

In other words, it's about the money. Significantly, the NEJM report suggests that government agencies and academic institutions funding such clinical trials may be “unable or unwilling to allocate adequate resources” that would enable such reporting to be submitted on schedule.

One possible reason for so little compliance is that presently the FDAAA law has no teeth. No penalties have ever been assessed against these scofflaws. A “possible reason,” according to the NEJM article, is that a Notice of Proposed Rulemaking went into effect in November 2014, and the period for public comment was extended by several weeks. However, this period is coming to a close March 23, 2015.

One possible solution presented in the article would be to require registration of results before they could be published in a peer-reviewed journal. Enforcing the stated penalties provided in the statute wouldn't hurt, either.

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