Richard Burr: “let me say, as Senator Dodd finishes, that nobody has worked more tirelessly than he on behalf of children's health and…”

“let me say, as Senator Dodd finishes, that nobody has worked more tirelessly than he on behalf of children's health and specifically as it relates to prescription drugs. He did list a long list of people, including taxpayers and so forth. This is about children, plain and simple. It is one group. It is our children, this country's kids. In 1997, I authored what became the Food and Drug Cosmetic Modernization Act. Prior to that, there weren't any clinical studies done for pediatric purposes. It was on the heels of that that Senator Dodd and others created the exclusivity--exclusivity that Senator Allard is not changing. What we are changing is in the base bill and going from 6 to 3 months. The reality is that, prior to the enactment, we didn't have companies that were studying the right dosages, what side effects there were, and whether it was effective in children. Sure, we had it for adults but not for kids. We have made tremendous progress. Under this pediatric exclusivity, though, we would cap it at 3 months. Companies that exceeded a dollar value--we pulled this out of the sky. Why $1 billion and not $2 billion? If it was $2 billion, why not $4 billion? Why not $100,000? The reality is that none of us knows. There is no expert who can tell us what is the right amount of incentive needed for a company to go through the types of trials to get these indications for kids. Why? Because every drug is different, and, more importantly, every child is different.”