What could be holding up FDA approval of much-needed generic Rebetol (ribavirin), Schering-Plough’s hepatitis C drug? The feds claim it’s label liability: By law, generic drug info must match that on patented meds, and the agency fears a lawsuit over language. And Schering claims it is not to blame for the FDA’s slo-mo. Still they stand to lose big bucks if cheap generics threaten to cop a share of the market. “Loss of pricing on Rebetol would be devastating to Schering-Plough’s margins,” said analysts from Sandford C. Bernstein & Co. And research wonk covering Big Pharma for investment firm GKM forecast generic competition being blocked for Rebetol “possibly until 2015” - though the patent popped last June. The Consumer Project on Technology’s Jamie Love said, “I suspect the FDA is protecting Schering, not the patients.” You be the judge.
C No Evil
April 1, 2003 • By Laura Whitehorn