Orphan bill moves up

WASHINGTON - The Senate Labor Committee last week passed legislation amending the Orphan Drug Act under the compromise reached by the industry and lawmakers in March.

S 1981 would reduce market exclusivity to four years, allow shared exclusivity for simultaneously developed drugs, and grandfather under the terms of the existing orphan law all drugs that have already been designated as orphans or that are currently in clinical trials(see BioCentury, March 25 & 28, 1994). The compromise bill avoids caps or limits on orphan revenues that had been threatened in earlier proposed amendments to the law...