Jack Reed: “I rise today to briefly describe an amendment that I filed to the fiscal year 2002 Emergency Supplemental Appropriations…”

“I rise today to briefly describe an amendment that I filed to the fiscal year 2002 Emergency Supplemental Appropriations bill currently before the Senate. Simply, my amendment dealt with the Food and Drug Administration's `Pediatric Rule,' which the agency issued in 1999 to require that companies conduct clinical trials in which children are the subjects for drugs that may provide a health benefit for the pediatric population. After discussing my amendment with several colleagues, I have decided not to offer it at this time. I believe, however, that this is an important issue that must be settled this year. In 1999, FDA issued new regulations requiring pediatric studies of certain new and marketed pharmaceutical and biological products. The agency determined that most drugs had not been adequately tested in the pediatric population. The 1999 rule requires that manufacturers of certain products provide sufficient data and information to support the directions for pediatric use for claimed indications. The pediatric rule filled an important gap in FDA's regulation of drug and biologic products.”