Rx Safety Conundrum: Where Does Labeling Stop And Medical Practice Begin?

An FDA advisory committee was near-unanimous that labeling cannot properly address potential risks of using single bottle of anti-inflammatory ophthalmic drops to treat both eyes after surgery – but the panel was divided on the question of whether using the drops in this way could be appropriate, wary of the agency getting involved in regulating the practice of medicine.

Last year FDA rejected an sNDA for a larger fill size of Ista Pharmaceuticals Inc.’s Bromday (bromfenac ophthalmic solution 0.09%), sending a “complete response” letter saying, among other things,...