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FDA proposes stiff fines for failing to report clinical trials

The US Food and Drug Administration (FDA) is proposing heavy fines for pharmaceutical companies that fail to report clinical-trial results online.

In a 20 September draft guidance statement, the FDA said that failure to register trials or submit results to the government database ClinicalTrials.gov could result in fines of up to US$10,000 per day.

The agency would send a notification letter to the company warning of an infraction. The company would then have 30 days to comply before facing fines. The public has 60 days to submit comments on the proposed rule.

Studies1 have found that about 58% of industry-funded trials and 61% of trials funded by the US National Institutes of Health in the United States did not report their results five years after completion. A 12 September paper2 in The BMJ found that roughly half of eligible clinical trials performed in the European Union were posted in the European clinical-trial registry.

doi: https://doi.org/10.1038/d41586-018-06801-7

Updates & Corrections

  • Correction 21 September 2018: This article incorrectly stated the percentage of industry-funded and publicly-funded trials that don't report their results. It should be 58% of industry-funded trials and 61% of trials funded by the US National Institutes of Health.

References

  1. 1.

    Anderson, M. L. et al. N. Engl. J. Med. 372, 1031–1039 (2015).

    PubMed  Article  Google Scholar 

  2. 2.

    Goldacre, B. et al. Br. Med. J. 362, k3218 (2018).

    Article  Google Scholar 

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