Drug Makers Routinely Submit Incomplete Reports of Side Effects to FDA

By Sandra Dalton, Staff Writer

When researchers analyzed the serious adverse event reports made to the U.S. Food and Drug Administration (FDA) in 2014, they found that reports filed by drug makers were incomplete more than half of the time, while more than 86% of those filed directly by health professional and consumers were complete. The FDA’s Adverse Event Reporting System is a crucial tool in evaluating drug safety in an age where drugs are approved quickly with little clinical testing. Incomplete data compromises the usefulness of the usefulness of this tool in formulating future warnings that could prevent injuries and save lives.

The Analysis

The report, published in the journal Pharmacoepidemiology and Drug Safety, evaluated serious adverse event reports for completeness. For the purposes of the study they needed to include all of the following to be considered complete:

• Age
• Gender
• Event date
• At least one medical term describing the event

Of the 528,192 new case reports received by the FDA in 2014, 4.7% were received directly from health professionals or consumers. Of those, 86.2% were complete.

95.3% of the reports were from drug manufacturers. Drug makers submit two types of reports. Expedited reports are to be made within 15 days of learning of a serious side effect. Periodic reports are made at a later date. Only 40.4% of the expedited and 51.3% of the periodic reports were complete.

When you consider this in addition to the recent revelation that Bayer and Johnson & Johnson misled editors of the New England Journal of Medicine in regards to Xarelto, it is no wonder so many people distrust the pharmaceutical industry.