FDA to retain pediatric rule

The Bush administration has reversed its decision to suspend implementation of the pediatric rule, which gives FDA authority to require that sponsors conduct clinical trials in pediatric populations as a condition for product approvals. The administration "will enforce and improve the FDA's pediatric rule," HHS Secretary Tommy Thompson announced on Friday. In contrast to documents filed in a federal court case seeking withdrawal of the rule, as well as recent congressional testimony by acting FDA Commissioner Lester Crawford, HHS stated that it will "defend the legal authority of the pediatric rule in court and will not pursue a stay of litigation." ...