Technicality is holding up lower-priced generic Ribavirin and other drugs.
M Peterson. The New York Times. January 3, 2003
Label issues are delaying generic drugs. When the patent on Rebetol, a drug used to treat hepatitis C, expired in June, patients hoped that they would be able to buy a generic form of the medicine to help lower the $20,000 cost of treatment. They are still waiting. The company that wants to sell a lower-price generic version of Rebetol says that government approval is being held up by a technicality that is proving to be quicksand for many generic medicines a dispute about the drug's label.
The manufacturer [of generic ribavirin], Three Rivers Pharmaceuticals, filed an application withthe Food and Drug Administration 17 months ago to make ribavirin, the generic name for Rebetol, which Schering-Plough sells for about $10 a capsule. While Three Rivers will not say how much it plans to charge, patient advocates say they expect ribavirin to sell for about half that price.

Paul F. Fagan, general counsel at Three Rivers, said that regulators have told the company that the delay stems from one sentence on the drug's label.
The label that the F.D.A. is focused on is not the one on the outside of the bottle or jar, but rather pages of information that physicians rely on. The label includes detailed instructions on how the medicine should be used, as well as information on its adverse side effects and results from clinical trials.

Under federal law, labels on generic drugs must be nearly identical to those of the brand name product they replicate. Regulators appear to fear that Schering could sue the government, Mr. Fagan said, if they let Three Rivers copy the sentence, which refers readers to the label of another Schering product, Peg-Intron, that is prescribed in combination with ribavirin.

Patient advocates say the high cost of Rebetol is causing many people with hepatitis C to go untreated. More than four million Americans are in