The issue of sameness of labeling for generic drug products continues to be under scrutiny from both the innovator as well as the law bar. However, from a historical perspective, the concept of carving out certain provisions of labeling covered by exclusivity continues to be an area where the FDA has made only a few exceptions. The FDA, in a recent petition denial (here) of the carve out provisions under both a 3-year Hatch-Waxman and the same use that garnered 7-year orphan drug exclusivity, has adopted much the same position as it has in numerous other cases and has approved generic versions of the innovator’s Crestor product without those protected indications.
In making a decision to carve out protected use or indication information, the FDA must determine that the generic drug product without the protected information is no less safe than the innovator product that contains the information. The FDA’s well-reasoned petition denial (see link above) outlines each of the Petitioner’s arguments and finds that the generic versions without the specific pediatric use information are no less safe than the innovator’s and also provides a rational for the inclusion of specific disclaimer language permitted by the statute (Pediatric Research and Equity Act [PREA] and Best Pharmaceuticals for Children Act [BPCA]).
There are only two instances that I can recall where the FDA denied ANDA approval because carving out the protected information would make the generic version less safe than the innovator product; those two drugs were Rapamune (petition approved in September 2004 (here) and for Colcrys (petition approved in May 2011 here). While there may be a third, I cannot for the life of me remember what it might be. I suggest you read the entire Petition response from FDA regarding the newest generic drug labeling carve out win for generics to fully understand this decision as well as others that have set precedent for Hatch-Waxman and orphan drug label carve-outs. To see more detailed information on the “Carve-out Scorecard”, we suggest looking at the FDA Law Blog which outlines most if not all of the various Petitions, responses and pending Petitions (here). While it may be a little out of date, the information contained in it is invaluable.