FDA proposes stiff fines for pharmaceutical companies and CROs that fail to post clinical trial results online

FDA building
FDA draft guidance proposes heavy fines on pharmaceutical companies and CROs that don’t post clinical trial results online. (FDA)

In a draft guidance statement, the FDA proposed levying heavy fines on pharmaceutical companies and CROs that don’t post clinical trial results online.

The regulatory agency said in its guidance that failure to register trials or submit results to the government database ClinicalTrials.gov could result in fines of up to $10,000 per day.

The agency would issue a notification letter warning a company of an infraction. The company would then have 30 days to comply with the FDA directive before any fines were issued.

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The public has 30 days to submit comments to the agency on the proposed ruling.

In its guidance, the FDA said it intends to identify violations relating to posting on the online data bank through evidence collected during inspections conducted as part of its Bioresearch Monitoring Program as well as from complaints it might receive.

The proposed guidance comes on the heels of a recent BMJ paper that said 49% of clinical trials on the European Register haven’t reported results. A 2015 study in the U.S. found that about 20% of industry trials didn’t report results when they were required to, and about 50% of NIH-sponsored research went unreported.