Most of the pharmaceutical industry has issued White Papers, blogged, sent letters to FDA, and lobbied their trade associations over the FDA’s Proposed Labeling Rule that would permit generic manufacturers to unilaterally add safety information to their approved labeling. Even Congress is getting into the act in trying to derail the FDA’s proposal. The Proposed Rule is in direct conflict with the statute and all regulatory advice the FDA has given since the passage of Hatch-Waxman. Generic manufacturers have always been instructed that their labeling must be the same as their brand name counterparts and if the brand name product is no longer on the market, then FDA’s regulations squarely place any safety label change on FDA’s shoulders. Today, I read a piece by Elizabeth Wright from Citizens Against Government Waste that is a must-read for all who want to fight for the sensible solution to a problem that does not exist; a problem that would, however, be created if the Proposed Rule issues in final as previously proposed.
Please read the article here. After reading, do something to protect the integrity of the labeling aspect of the current statute and the generic drug process related to labeling.