I am pleased to be joined today by Senators Alexander, Murray, and Roberts in introducing the Better Pharmaceuticals and Devices for Children Act, BPDCA. This legislation will ensure that children are prioritized in the drug development process, as well as continue the increase in the number and quality of medical devices developed for use in children. I am particularly pleased that this bill has the support of the American Academy of Pediatrics and the Pharmaceutical Research and Manufacturers of America. Indeed, drugs and devices work differently in children than in adults, and consequently, must be studied specifically for use in children. However, due to the fact that pediatric trials can be costly, take several years, and offer less of a return on investment, drug companies weren't initiating these trials. As a result, nearly 80 percent of drugs were used off-label in children. This alarming statistic garnered the attention of pediatricians, medical experts, families, and ultimately, Congress. In 1997, Congress provided pharmaceutical companies with an incentive to invest in pediatric research through the Best Pharmaceuticals for Children Act, BPCA. In 2003, Congress passed the Pediatric Research Equity Act to begin requiring pharmaceutical companies to engage in these studies.…
On the recordApril 17, 2012
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