FDA Reverses Decision to Abandon Pediatric Rule

Elizabeth Glaser Pediatric AIDS Foundation
Friday, 19 April 2002

On Friday, April 19, 2002, Health and Human Services Secretary Tommy G. Thompson announced that the FDA had reversed its decision to abandon the Pediatric Rule, an essential protection that ensures drugs are properly labeled for pediatric use based on scientific studies.

Seventy-five percent of all drugs prescribed for children are not tested for use in children. The Pediatric Rule, along with the Best Pharmaceuticals for Children Act, which offers incentives to drug companies for testing drugs for use in children, work hand-in-hand to make sure that the drugs our children use are safe and effective. Neither approach without the other will fully ensure that specific medicines vital for use in children will be tested in a timely manner.

The Pediatric Rule has come under attack in recent weeks and it appeared as though the Rule would be eliminated or suspended. This would have been a major set back for the health of our nation's children. In response, the Foundation took immediate action to preserve the rule.

The Foundation and the American Academy of Pediatrics representatives met with Dr. Lester Crawford, the Acting Commissioner of the FDA, to ask for his help in preserving the Pediatric Rule. There were also several letters of concern sent to the President and the FDA by Members of Congress, the American Academy of Pediatrics and the Foundation.

Finally, on April 17, Senators Hillary Rodham Clinton (D-NY), Mike DeWine (R-OH) and Chris Dodd (D-CT) announced a plan to introduce legislation that would make the Pediatric Rule, which now exists as a regulation, a law. The much-needed law would require manufacturers to test the safety and dosing of their medicines for children.

The Foundation applauds the administration's recent announcement to protect the Pediatric Rule, for recognizing its importance and for agreeing once again to defend it against attacks. The Foundation also applauds the administration for finding money -- $7 million -- to conduct pediatric studies of drugs in cases where the drug industry is not following through.

But the last few weeks have sent a clear message that the Pediatric Rule is on very thin ice so long as it remains a regulation and not a law. The health of our children is at stake during all of this uncertainty. That's why the Foundation still strongly supports codification of the Pediatric Rule. That action, and that action alone, will safeguard children and give them the same information about the safety and dosing of drugs that we demand for ourselves as adults.

For more information, or to contact Elizabeth Glaser Pediatric AIDS Foundation, see their website at: www.pedaids.org