Chris Dodd: “let me go back, if I can, to my proposal on the Best Pharmaceuticals for Children Act and the objections raised by my…”

“let me go back, if I can, to my proposal on the Best Pharmaceuticals for Children Act and the objections raised by my colleague from Colorado to it. Just for the record and so we understand what we are talking about, according to a study recently published in the Journal of the American Medical Association that looked at the costs and benefits of these pediatric trials. It showed that the overwhelming majority of drugs studied under this incentive program are not blockbusters. In fact, the study found that less than 20 percent were. That leaves 80 percent of drugs completely unaffected by the underlying bill which the Allard amendment seeks to amend. To be clear, the proposal in the underlying bill that would adjust exclusivity from 6 months to 3 months affects less than about 20 percent of drugs studied under this program. Using data from this recent study, 80 percent of drugs studied under BPCA--those which do not fall into the blockbuster category--the 6 months' exclusivity would remain unchanged. It doesn't change that at all; only in cases where there has been over $1 billion in prior year drug sales will the underlying bill change the exclusivity to 3 months. This is to strike a balance. Obviously, I feel very strongly, having authored this legislation, about ensuring that appropriate clinical trials occur to protect children's health.”