Mr. President, I rise today to introduce the Best Pharmaceuticals for Children Amendments of 2007, which is a bill to reauthorize the Best Pharmaceuticals for Children Act--BPCA. If Congress doesn't act, this successful program will expire…
Mr. President, I rise today to introduce the Best Pharmaceuticals for Children Amendments of 2007, which is a bill to reauthorize the Best Pharmaceuticals for Children Act--BPCA. If Congress doesn't act, this successful program will expire on October I, 2007. I thank my colleagues Senators Kennedy, Harkin, Bingaman, Murray, Clinton and Brown who are joining me as original cosponsors of this important legislation.
I am pleased that Senators Kennedy and Enzi, the distinguished chairman and ranking member of the Health Education Labor, and Pensions--HELP--Committee, have included this bill in the chairman's mark for S. 1082, which is expected to be voted on today in the HELP Committee.
I would also like to recognize the contributions and leadership of former Senator Mike De Wine, a friend and colleague, who always fought to ensure children would not be treated as second-class citizens when it came to drug and device development. He was a champion of BPCA along with me even when it wasn't popular to hold that view.
The story of the Best Pharmaceuticals for Children Act is one of huge success for children and their families. Children with a wide range of diseases such as HIV/AIDS, cancer, allergies, asthma, neurological and psychiatric disorders, and obesity can now lead healthier, more productive lives as a result of new information about the safety and efficacy of drugs they use to treat and manage their diseases where previously there was none.
Children are not simply little adults and results of the drug studies conducted under the BPCA have shown us that they should not be treated as such. Pediatric drug studies conducted. under the BPCA showed that children may have been exposed to ineffective drugs, ineffective dosing, overdosing, or side effects that were previously unknown.
Since the BPCA's passage in 1997 and its reauthorization in 2002, FDA has requested nearly 800 studies involving more than 45,000 children in clinical trials. Useful new pediatric information is now part of product labeling for 119 drugs. By comparison, in the 7 years prior to the BPCA's passage, only 11 studies of marketed drugs were completed. In the past 10 years, there has been a twentyfold increase in the number of drugs studied in infants, children, and adolescents since BPCA was enacted.
Labeling changes resulting from clinical studies under the BPCA have informed physicians of the proper dosing in the examples of Viracept, a protease inhibitor used in a combination therapy for the treatment of HIV, and Neurontin, a pain relief medication used to treat children with chronic pain. For children with epilepsy, the BPCA studies informed physicians that the drugs Keppra and Trileptal could be used safely and effectively at an even earlier age than previously known. Studies of Imitrex as a result of the BPCA showed no better results than placebo for the treatment of migraine headaches in adolescents. These same studies also showed serious adverse events due to Imitrex in pediatric populations and therefore the drug is not recommended to treat migraines in anyone less than 18 years of age.
Recent studies of the BPCA by the Government Accountability Office-- GAO--and by several authors from Duke University in an article which appeared in the Journal of the American Medical Association--JAMA--have demonstrated that the program is a success and have identified opportunities to strengthen the program. Authors of the recent JAMA article found that outside of the BPCA, the FDA is limited in the number and scope of studies for which it can require pediatric data for existing products on the market.
Data from this article showed that only a minority of drugs studied under the BPC, about 20 percent, had more than $1 billion in annual sales. In fact, the median drug granted exclusivity was a small-market drug with annual sales of $180 million and 30 percent of drugs studied had sales less than $200 million. This article went on to say that a universal reduction in the length of pediatric exclusivity from 6 to 3 months would mean that products with small profit margins may not be submitted for pediatric testing.
The BPCA has always tried to strike the right balance between cost to consumers and benefits to children. I believe there is an ongoing need to evaluate the cost of the incentive as it relates to reaching the goal of having medications properly studied and labeled for children. In fact, that is why I strongly support a 5-year sunset of the BPCA.
After 10 years, experience and data has shown us that for a small number of drugs, pediatric exclusivity has far exceeded the ``carrot'' it was intended to provide for manufacturers. As the authors of the recent JAMA article noted, ``our study shows that the Pediatric Exclusivity Program overcompensates blockbuster products for performing clinical trials in children, while other products have more modest returns on investment under this program.''
The bill I am introducing today contains a reasonable, workable proposal to address cost concerns without jeopardizing the extraordinary success of BPCA. I have worked closely with the chairman and ranking member of the HELP Committee to craft this proposal into the form it appears in this legislation and in the bipartisan chairman's mark which is expected to be voted on in the HELP Committee today.
On March 27, the HELP Committee held a hearing, which I chaired, entitled ``Ensuring Safe Medicines and Medical Devices for Children.'' We learned from pediatricians and a parent of five children, four of whom are HIV-positive, Mrs. Susan Belfiore, about the tremendous impact BPCA has had on the quality of life for countless numbers of children and their families. We received testimony with many suggestions for improvements to BPCA which I believe are reflected in this bill. I would also add that in the month since I circulated this bill as a draft, I received comments from several pharmaceutical companies. Some have been strongly supportive of this effort and many of their ideas and suggestions are incorporated in this bill.
The success of the BPCA has transformed the drug development process for children. It is my hope that we will achieve similar success with another piece of legislation I recently introduced called the Pediatric Medical Device Safety and Improvement Act. It is also contained within the chairman's mark to S. 1082 and I thank Chairman Kennedy and Ranking Member Enzi for working with me to ensure that medical devices used in children are safe and are designed specifically for their use.
The BPCA has had a long history of bipartisan support and it has been my longstanding hope that this initiative will continue to be bipartisan as the chairman's mark to S. 1082 moves to the Senate floor. The safety of our Nation's children is not a partisan issue.
As the parent of two young children, I know that it is essential that products used in children's growing bodies, whether they be drugs or devices, are appropriately tested and designed specifically for their use. We must continue the tremendous success of BPCA and its complementary program, the Pediatric Research Improvement Act, of which I am an original cosponsor, by strengthening both programs through the reauthorization process this year. It is essential that we use the past experience of both programs to ensure they will continue to thrive in the future.
I urge my colleagues to support this legislation.
I ask unanimous consent that the text of the bill be printed in the Record.