April 17, 2002

Senators Hillary Rodham Clinton (D-NY), Mike DeWine (R-OH) and Chris Dodd (D-CT) announced today they plan to introduce legislation that would reinstate the "Pediatric Rule" at the Food and Drug Administration. The rule would require manufacturers to test the safety of their medicines for children.

On March 18, the FDA announced that it would suspend the Pediatric Rule, which was put in place in 1998.

Statement Of Senator Clinton
Doctors have known for a long time that children respond differently than adults to many drugs. But we provide adults with assurance that drugs on the market are safe and effective. Yet safety for our children can evaporate in a moment, as quickly as the FDA changes its mind. The FDA's recent announcement shows that if we want to protect our children over the long term, then we in Congress need to step in and make the Pediatric Rule the law of the land. Short of taking that action, we risk denying children the protection that we require for adults.

Statement Of Senator DeWine
By keeping the Pediatric Rule, two excellent vehicles will remain in place to save and improve the quality of children's lives. As an original author and supporter of the Best Pharmaceuticals for Children Act (BPCA), I believe it's imperative to ensure the Pediatric Rule remains in place and that the Rule and BPCA continue to work hand and hand to give doctors the best available information to help children. When Senator Dodd and I originally authored our legislation, we never intended for it to replace the Pediatric Rule.

Statement Of Senator Dodd
The requirement that certain drugs and biologics be studied for safety and efficacy in children under the Pediatric Rule has worked in conjunction with the voluntary incentives program for testing that Senator DeWine and I authored to ensure that every appropriate medicine for kids can get tested for kids. We can hardly afford to do without one when we do not have necessary information for kids for a majority of the medicines on the market. Taking away either of these tools would represent a step backward for children's health.

Learn More:
April 19: Senators React To New FDA Announcement On Pediatric Rule