Warning letters commanded greater attention in 2010 than in recent memory. Consent decrees and executive prosecutions also rose in status.
Warning letters have gotten more specific. A tone of exasperation or depleted patience has given way to curt direction.
The new tone suggests something bad will happen if you don't follow through. Bluff or solid hand? Bad things are already happening: The FDA now posts Form 483 inspection reports, available for all to see, in addition to warning letters.
Occasional stories in the daily press now mention FDA warning letters and include phrases and quotations taken from them. Stories about warning letters are proliferating in the trade press, and they include links to both the posted warnings and sometimes the 483s.
The question is whether the agency will continue along these lines in 2011. Congress flashed some muscle of its own directed at the FDA, with investigations into contaminated heparin and the J&J recalls. Both contributed a bit of tarnish to the regulator's finish. Congress's pro-regulation elements had the upper hand in 2010; it's unclear whether that will be the case in 2011.
Special Report: Frightening Phrases: Warning letter language to watch. Report