Legislation granting six months of exclusivity for pediatric research reintroduced by Sens. Dodd and DeWine.
Executive Summary
PEDIATRIC PHARMACEUTICAL BILL WITH JAN. 1, 2004 SUNSET INTRODUCED MAY 7 by Sens. Dodd (D-Conn.) and DeWine (R-Ohio) as S 713, "The Better Pharmaceuticals for Children Act." In keeping with the approach taken by former Sen. Kassebaum (R-Kan.) in the 104th Congress, the bill would offer six months of extra exclusivity to encourage pediatric research. However, in an apparent acknowledgment of the concerns of generic drug manufacturers about the Kassebaum bill, the Dodd/DeWine measure would require a report on the effectiveness and economic impact of the bill by Jan. 1, 2003 and would sunset the incentives a year later.