House Approves Legislation To Turn Pediatric "Rule" Into Pediatric Law

Elizabeth Glaser Pediatric AIDS Foundation
Wednesday, 19 November 2003

Bill Providing Essential Protection for Children's Health Now Moves Directly to President for Signature

The House today overwhelmingly approved the Pediatric Research Equity Act of 2003 (S. 650/H.R. 2857), which restores the protections of the Food and Drug Administration's 1998 Pediatric Rule. This essential regulation, which required drug companies to test their products for use in children, was invalidated by a federal district court in October 2002. S. 650, which passed by voice vote, will soon give the Pediatric Rule the strength of law.

The Senate unanimously approved identical legislation in July. Following the House vote, the bill moves to President Bush's desk for signature. Given the administration's endorsement of the legislation, it is expected that the President will sign the bill into law.

"Today was a major victory for children everywhere and truly one of the most important days in the history of children's health," said Mark Isaac, Vice President of the Elizabeth Glaser Pediatric AIDS Foundation. "This is a law that will benefit every child and every family by finally guaranteeing children the same access to safe and effective medicines that we demand for ourselves as adults."

"I am thrilled that medicines for children will finally receive the same scrutiny as medicines for adults," said Senator DeWine (R-OH), a key author of the bill. "Nothing is more important than the health of our children. It was a long fight, but finally the FDA has all the tools it needs to ensure that the medicines we give our children do what they were intended to do -- ease their pain or make them healthy."

Representatives from the Elizabeth Glaser Pediatric AIDS Foundation have worked closely with Congress, the Administration and organizations, including the American Academy of Pediatrics to restore the protections of the Pediatric Rule. The Foundation commends Representatives Jim Greenwood (R-PA), Anna Eshoo (D-CA), and Deborah Pryce (R-OH) and Chairman Billy Tauzin (R-LA) for their leadership on this critical issue for children. The Foundation also commends members of the Senate, including Senators Mike DeWine (R-OH), Hillary Clinton (D-NY), Judd Gregg (R-NH), Christopher Dodd (D-CT), and Edward M. Kennedy (D-MA).

The Pediatric Research Equity Act of 2003 will require manufacturers to test the safety and dosing of all new medicines and some already marketed medicines for children. It will also ensure that drugs are available in forms young children can readily use, such as liquids and chewable tablets. While applauding Congress for passing this legislation, the Foundation continues to oppose the "sunset" clause in the bill, which causes the fundamental safeguards of the Rule to expire in four years.

Most Americans are shocked to learn that about three-quarters of drugs used by children have not been tested for their use, despite the fact that their small bodies metabolize drugs differently than adults. In some cases children have died or been seriously injured after taking drugs that were safe for adults but not tested specifically for use in children. More often, children are overdosed or under-dosed, resulting in drug resistance, adverse side effects, longer illnesses and higher costs to the health care system.

In the three years it was in place before it was struck down by the courts, the Pediatric Rule, along with an active federal incentive program that provides valuable patent extensions for companies that voluntarily conduct pediatric drug tests, generated hundreds of studies that lead to invaluable safety and dosing information, compared to 11 studies conducted in the 6 years prior to these initiatives.

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