FDA Wants To Leverage Electronic Medical Records To Probe For Adverse Events

Keeping track of adverse events is a tricky task, even for regulators. Even when a drug has undergone a rigorous premarket assessment process, some risks may not become evident until a product is used by millions. And for other drugs, a particularly rare but serious side effect may take months, if not years, to be identified.

But being a regulator in 2014 means having access to something regulators of old did not: Big data.

In late December 2013, the US Food and Drug Administration (FDA) quietly announced that it plans to begin leveraging that data to better assess drugs in post-market settings, allowing it to determine which drugs may be definitely dangerous, and which ones may need targeted warnings to tailor their appropriate use.

At present, side effects are reported to FDA voluntarily, usually by healthcare professionals or companies using a variation of Form FDA 3500. As of 2013, consumers can also report side effects using Form FDA 3500B.