Bart Stupak: “I rise tonight to urge Members to vote against H.R. 2887, the Pediatric Exclusivity Act, as it is on the suspension…”

“I rise tonight to urge Members to vote against H.R. 2887, the Pediatric Exclusivity Act, as it is on the suspension calendar with controversial provisions. First approved in 1997, pediatric exclusivity granted the drug companies an extra 6 months extension on their patents if they would provide a study to determine if the drug was beneficial to young people. Upon completion of that study, the FDA grants a pediatric exclusivity to the drug which the drug companies then used as a marketing tool to promote and increase drug sales. The grant of pediatric exclusivity only takes place upon completion of a study without anyone knowing what the study says about the safety, the effectiveness and dosage requirements for young people. There is no requirement to change the labeling on the drug to reflect the changes needed. There is no label to tell the doctors what is the proper dosage, how to dispense and use the drug safely. Before we grant pediatric exclusivity to a drug and it is then marketed as being FDA approved for pediatric use, we should at least know what is the effect of the drug on young people. Under the current bill, after the study is completed, exclusivity is granted, but whether the drug helps or hurts young people remains a secret and is not disclosed to doctors, patients, or their families. Physicians, patients, and their families should have a right to know about the drug before they ingest it.”