Forest Runs into Tree

The presentation Forest Laboratories Inc. made at last week's Pulmonary-Allergy Drugs Advisory Committee about Daxas roflumilast to treat COPD would have been perfect - if it had been made a decade ago. For better or worse, FDA has moved on, so instead of the endorsement Forest hoped for, a regulatory strategy and procedural tactics out of synch with the realities of 2010 produced a 10-5 recommendation against approval.

Forest's experience hammers home some of the changes a decade's focus on drug safety have wrought...