Legislation granting six months of exclusivity for pediatric research reintroduced by Sens. Dodd and DeWine.
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth