Monday, November 12, 2012

FDA Adds Authority over Clinical Trials

Searcy, Denney

Where, oh where does clinical trial data go?

Earlier this year, the British Medical Journal (BMJ) wrote that a large proportion of evidence from human clinical trials goes missing while cherry-picked favorable data appears. According to the BMJ, fewer than half of the data from clinical trials run using National Institutes of Health (NIH) funding reported data within three years, or two years past the mandatory deadline. And about 22 percent of clinical trials data was reported within one year.

This is what happens when drug manufacturers do not take seriously the authority of the U.S. Food and Drug Administration in overseeing drug approvals.

The Department of Health and Human Services has established the databank for clinical trials, which exists now as www.ClinicalTrials.gov run by the National Institutes of Health. This is supposed to be the place where clinical trials post information about the design of the study, its sponsor and where it’s being conducted.

Now FDA Commissioner Margaret Hamburg has new added authority over clinical trials, according to a posting in the Federal Register. According to the notice, the FDA will be given authority to pursue, “any clinical trial information (that) was not submitted as required under (federal law) or was submitted but is false or misleading in any particular…”

It is about time. Remember the scandal associated with Merck and the hidden data that showed its Vioxx painkiller carried a risk of stroke and heart attack? Or GlaxoSmithKline’s $3 billion settlement over its failure to report safety data on Avandia? An analysis published in PLoS Medicine found those clinical trials sponsored by industry were less likely to have their results published.
Does this mean the FDA has greater authority to actually do something?

Not exactly. The Federal Register notification continues that the FDA will follow up, “to notify the responsible party and give such party an opportunity to remedy non-compliance by submitting required revised clinical trial information not later than 30 days after such notification.”

It is unclear whether the FDA will receive any additional funding to impose sanctions and do a real job of oversight to hold responsible parties accountable. With Congress issuing funding for the FDA, while also being funded by a tax imposed on pharmaceutical and medical device companies, there is little incentive to give the lap dog FDA any more teeth to bite.

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