April 17, 2002

Senators Hillary Rodham Clinton (D-NY), Mike DeWine (R-OH) and Chris Dodd (D-CT) welcomed news that the FDA would reinstate the "Pediatric Rule," but they also said their plans for legislation to codify the rule are unaffected by today's announcement.

The Pediatric Rule requires manufacturers to test the safety of their medicines for children. On March 18, the FDA had announced that it would suspend the Pediatric Rule, which was put in place in 1998.

Senators Clinton, DeWine and Dodd announced on Wednesday their intention to introduce legislation to codify the Pediatric Rule.

Statement Of Senator Clinton
While I am pleased that the FDA has changed its mind about the Pediatric Rule, the fact that it can change its mind illustrates how important it is to make this rule the law of the land. In that way we can have continuing confidence that drugs are safe, effective and properly labeled for children, as they are for adults.

Statement Of Senator DeWine
I am extremely pleased with Secretary Tommy Thompson's decision today regarding the Pediatric Rule. As an original author of the Best Pharmaceuticals for Children Act (BPCA), I felt it was imperative for the Pediatric rule to work hand and hand with the BPCA. While I applaud this decision, I believe we must ensure the Pediatric Rule is never put in future jeopardy. This is why I will continue my work in the United States Senate to make the Pediatric Rule law.

Statement Of Senator Dodd
I'm glad the FDA has recognized the importance of this rule, and I commend them for taking this action. However, as we've seen before, what can be "done" can just as easily be "undone." That's why Senators DeWine and Clinton and I intend to go forward with our legislation to codify this rule. Our children's health is simply too important not to have every tool and backstop in place to help with drug testing.