BioCentury
ARTICLE | Politics, Policy & Law

The ugly underbelly

How FDA leak revelations pit scientific debate, regulatory decisions

July 23, 2012 7:00 AM UTC

The inadvertent release of documents related to an FDA investigation of five employees suspected of leaking confidential information shines a spotlight on a dysfunctional culture at FDA's Center for Devices and Radiological Health.

But the controversy over the investigation - which included cyber monitoring of employee computers - raises an issue much bigger than the dysfunction of one division of one government agency. It is the ability to discuss divergent scientific opinions while balancing the absolute imperative to make decisions that will inevitably run counter to the strongly held views of some agency employees...