Henry Waxman: “I rise in support of the Pediatric Research Equity Act, and I urge other Members to support it as well. This legislation…”

“I rise in support of the Pediatric Research Equity Act, and I urge other Members to support it as well. This legislation has been a long time in coming. Physicians have known for decades that failing to test drugs in children could have deadly consequences. It was not until the late 1990s that Congress and the FDA finally acted to ensure testing of drugs in children. In 1997 Congress enacted a bill giving pharmaceutical companies generous financial incentives for voluntarily conducting pediatric studies. A year later, FDA finalized a regulation known as the Pediatric Rule, requiring companies to conduct studies in children for important or widely used drugs, and that regulation was regarded by both the FDA and by physician and patient groups as essential because the financial incentives still left many important drugs and many age groups unstudied. Unfortunately, the Pediatric Rule was struck down by a district court last year. I believe the case was wrongly decided and that FDA had adequate authority; but we need to codify the rule now, as this bill would do, in order to provide children with the strongest protection of their right to receive medicines that are as safe and as effective as the medicines given to adults. While I strongly support this bill, there is one provision I do not support. The bill contains a sunset provision which will repeal in 5 years the protections for children that this bill is designed to provide.”