Mr. Speaker, I thank the distinguished chairman of the Health Subcommittee as well as all of my colleagues that have worked so hard to bring this bill forward. So I rise, obviously, in support of it because I think the bill is going to…
Mr. Speaker, I thank the distinguished chairman of the Health Subcommittee as well as all of my colleagues that have worked so hard to bring this bill forward. So I rise, obviously, in support of it because I think the bill is going to make an enormous difference in the safety and the effectiveness of drugs and medical devices used to treat adults and children.
I think the bill also strengthens the FDA. I think the American people want the FDA to be an agency that is strong in its protection of consumers around the country. We know that there have been shortcomings that have had terrible effects on many families in our country. So, I think this bill is a victory in that arena.
I am also pleased that the bill adopts much of my legislation relative to children and pharmaceutical drugs for children. The American Academy of Pediatrics has instructed us that only about 25 percent of drugs administered to children have been appropriately tested and labeled for use in kids. Pediatricians often had to prescribe adult pharmaceuticals for children by telling parents, ``cut the pill in half, cut it in thirds, cut it in quarters.'' We understood that we had to do better. By every measurement, the reauthorization of this legislation, previous legislation, was supported because it was very, very successful. We know that children are not small adults, and the legislation recognizes that. We have reauthorized, and we are doing the right thing.
I am pleased that the blockbuster provision is not a part of this legislation. The other body supported that. I didn't. This bill doesn't. In all negotiations, there is always give-and-take. There are items I supported that didn't make it into the package, including the permanent extension of the Pediatric Research Equity Act, which I championed, obviously, as part of my legislation in the original House bill. I hope that we can get to this at some point. I am sorry it is not in this bill.
Overall, I want to thank all of my colleagues that made this possible and that we are here today; certainly, Chairman Dingell, Ranking Member Barton, most especially the professional staff, because they do so much work, no one more than John Ford of our staff, and Virgil Miller. I would like to also thank Jennifer Nieto Carey, formerly of my staff, who worked so hard and extensively to help bring us to this point.
So this is a good bill. I think the whole House should support it. I think it is a tribute to the substance of it, that it is coming up under suspension. I salute everyone that made the effort a winning one. Most importantly, I think the bill is a winner for the people of our country, both children and adults.
Mr. Speaker, I rise in support of H.R. 3580, the Food and Drug Administration Amendments Act.
This bill will make an enormous difference in the safety and effectiveness of drugs and medical devices used to treat adults and children.
I'm pleased that the bill adopts much of my legislation (H.R. 2589, Improving Pharmaceuticals for Children Act) to renew the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Together, BPCA and PREA represent two halves of a comprehensive effort to make sure that prescription drugs are appropriately tested and labeled for children.
According to the American Academy of Pediatrics, about 25 percent of drugs administered to children have been appropriately tested and labeled for use in kids. Pediatricians often have to prescribe drugs for ``off-label'' use, because the drug has not been studied in appropriate FDA-approved pediatric clinical trials. Children are not small adults; they have specific medical needs that have to be considered when drugs are used. Children have died or suffered serious side effects after taking drugs that were shown safe for use in adults but had different results in children.
The bill helps improve drug safety for children in two ways. First, under BPCA, the bill provides an incentive, an extra 6 months of marketing exclusivity, for a drug if the innovator company agrees to undertake comprehensive pediatric studies requested by the FDA. Second, under PREA, FDA is granted authority to require studies when there is a demonstrated need and drug companies are required to submit a pediatric assessment each time they apply to market a new drug or change an existing drug's indication.
I'm pleased this bill continues the BPCA incentive without the so- called ``blockbuster provision'' adopted by the Senate. The Senate's proposal would have reduced the incentive for drugs with annual sales of $1 billion, and, I believe the Senate language had the potential to kill ``the goose that laid the golden egg.'' The 6-month incentive has worked. According to GAO, 81 percent of the time FDA has offered this incentive for a drug, drug companies have accepted, undertaking studies that have generated pediatric data that would otherwise not have been available. Scaling back the incentive for ``blockbusters'' would risk that proven record of success. That is a gamble on the
health of children, and I'm pleased it's not in the bill.
In all negotiations there is give and take. There are items I supported that didn't make it into this package, including the permanent extension of PREA which I championed as part of my legislation and the original House bill. I hope we'll have a chance to revisit the issue in the next reauthorization, if not sooner.
On balance, this bill will make a huge improvement in the safety of drugs and devices. We should pass it and send it to the President today.
I want to commend Chairman Dingell, Ranking Member Barton and the professional staff of the House Energy and Commerce Committee, especially John Ford and Virgil Miller, as well as Jennifer Nieto Carey formerly of my staff, who worked extensively on this bill.