“The question is not whether we should study the safety of drugs for children, but how we make that research happen,” and the Best Pharmaceuticals for Children Act, which will expire this year, “has generated more clinical information for the pediatric population than any other legislative or regulatory effort to date,” Sen. Tom Coburn (R-Okla.) writes in a Washington Times opinion piece. According to Coburn, the law, under which pharmaceutical companies that test their medications in children can receive six months of market exclusivity, is “a win-win situation” in which companies “have an incentive to invest time and extra resources for a small share of the market, and, more importantly, children get the research they need.” Coburn writes that, because of the law, 25 medications include proper dosage information for children, 35 include improved safety data and 24 include warnings against use in children. “Despite BPCA’s success, there are efforts to diminish its ability to encourage new research,” Coburn writes, adding that “well-intentioned but misguided efforts to change it will produce fewer results for children.” In addition, some lawmakers have proposed to end the law in 2012 and permanently authorize the Pediatric Research Equity Act, which allows FDA to require pharmaceutical companies to test their medications in children in certain cases, but, according to Coburn, “this approach will ultimately lessen the number of new pediatric studies and also restrict children’s access to cutting-edge medical technology.” He adds, “In order to make sure children have the research and drugs they need to win difficult battles against cancer or diabetes, the two programs should both be re-examined in 2012 or both be made permanent”
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