Health and Human Services Secretary Tommy Thompson announced April 19 that the Federal Drug Administration 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 (see article in 4/20 edition), work hand-in-hand to make sure that the drugs children use are safe and effective.
According to the Elizabeth Glaser Pediatric AIDS Foundation, “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 it would be eliminated or suspended.
“This would have been a major setback for the health of our nation’s children,” the foundation announced, in taking immediate action to preserve the rule.
Representatives of the foundation and the American Academy of Pediatrics (AAP) met with Dr. Lester Crawford, the FDA acting commissioner, to ask for his help in preserving the Pediatric Rule.
Letters of concern were also sent to President Bush and the FDA by members of Congress, the AAP and the foundation.
Finally, on April 17, Senators Hillary Rodham Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Chris Dodd (D-Conn.) announced a plan to introduce legislation that would make the Pediatric Rule – which now exists as a regulation – a law. The law would require manufacturers to test the safety and dosing of their medicines for children.
The foundation applauded the announcement to protect the Pediatric Rule and the fact that the administration found 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 foundation said in a press release.
“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.”
The author can be reached at crummel@pww.org
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