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In a 20 September draft guidance statement , the FDA said that failure to register trials or submit results to the government database Clinicaltrials.gov could result in fines of up to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.
Studies 1 have found that about 20% of industry-funded trials and 50% of publicly-funded trials in the US do not report their results. A 12 September study 2 in The BMJ found that just over half of clinical trials performed in the EU were posted in the European clinical trial registry.