Elizabeth Glaser Pediatric AIDS Foundation Supports Federal Pediatric Drug Testing

The Elizabeth Glaser Pediatric AIDS Foundation yesterday said in a release that it "welcomes" the announcement by federal health officials to test 12 drugs "commonly prescribed" for children because their safety and effectiveness has only been tested in adults (EGPAF release, 1/21). The drugs, which will be tested by the NIH and then reviewed by the FDA, were targeted by the National Institute of Child Health and Human Development in conjunction with the FDA and experts in pediatric research. The drugs, which are no longer under patent, include azithromycin, lithium, baclofen, bumetanide, dobutamine, dopamine, furosemide, heparin, lorazepam, rifampin, sodium nitroprusside and spironolactone. Last year, President Bush signed into law the Best Pharmaceuticals for Children Act, which called for pediatric drug testing. According to HHS Secretary Tommy Thompson, up to $25 million will be available for testing in fiscal year 2003 and up to $50 million in additional funding will be included in Bush's FY 2004 budget proposal next month; the FDA will provide $18 million. Thompson said the testing is necessary because children "often react differently to drugs than adults do" and that the testing will help to "fully understand the effects of these medications in children" (HHS release, 1/21). "The Administration has taken an important first step toward improving children's health," Pediatric AIDS Foundation President and CEO Kate Carr said. "We now urge Congress to follow through on [the pediatric drug testing] announcement by appropriating money for this important research in FY 2004. The drug industry must do its part as well. Dozens more off-patent drugs now need to be tested for children and that number will only grow. Pharmaceutical companies should also step up to the plate and help taxpayers shoulder the cost of ensuring the safety and effectiveness of drugs for children" (EGPAF release, 1/21).