Bart Stupak: “I rise today to urge Members to vote against H.R. 2887, the Pediatric Exclusivity bill, as it will appear on the…”

“I rise today to urge Members to vote against H.R. 2887, the Pediatric Exclusivity bill, as it will appear on the suspension calendar tomorrow. It has a number of controversial provisions. First approved in 1997, pediatric exclusivity granted the drug companies an extension of 6 months under patents if they would provide a study to determine if the drug was beneficial to young people. The FDA invites drug companies to do a study on what effect the drug may have on young people. Upon completion of the study, the FDA then grants a pediatric exclusivity to the drug, which the drug companies then use as a marketing tool to promote and increase drug sales. The grant of pediatric exclusivity takes place after the drug company study is completed, without anyone knowing what the study says about the safety, the effectiveness, or the dosage requirement for young people. There is no requirement to change the labeling on a drug to reflect the changes that may be needed when a drug is dispensed to young people.”