FDA Study Spanks Drugmakers for Poor Adverse Events Reporting

Saturday, February 7, 2015

Source: Fierce Pharma

Gilead Sciences' ($GILD) hep C drug Sovaldi (sofosbuvir) has had a stellar year, with huge sales because of cure rates that top 90%. But is it safe? According to adverse events reporting, the FDA says it appears to be, but then that is a bit hard to determine. That, the agency says, is because Gilead, like many other drugmakers, has done such a poor job of reporting drug side effects.

The new report on adverse reporting says drugmakers in general do a bad job of getting basic information, rendering unreliable the FDA's primary tool to track the safety of drugs after approval. The report points out that drugmakers account for 96% of the reports it gets but fewer than half are considered complete. That compares with the FDA-collected reports, which are complete 85% of the time. The study looked at 847,000 reports made during the 12 months that ended March 31, 2014.

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