Critical Children's Health Measure Signed Into Law By Presdient Bush

Elizabeth Glaser Pediatric AIDS Foundation
Friday, 4 January 2002

President Bush signed the Best Pharmaceuticals for Children Act into law on January 4, 2002. The new law, a top policy priority for the Elizabeth Glaser Pediatric AIDS Foundation, extends crucial incentives that have dramatically improved safety and dosing information for children about prescription drugs, most of which have never been tested for use in children. The law also includes a series of changes designed to further improve the use of children's therapies.

"The Best Pharmaceuticals for Children Act is one of the most important advances in children's health in recent years," said Kate Carr, President and Chief Executive Officer of the Foundation. "By providing children with the same safety and dosing information that we demand for ourselves as adults, this crucial law is improving health care for children, saving lives, and reducing hospitalizations.

"We at the Elizabeth Glaser Pediatric AIDS Foundation are elated that the President has signed this crucial, pro-child legislation into law," Carr added. "The children of the nation are also deeply indebted to our heroes on Capitol Hill, including Senators Dodd (D-CT) and DeWine (R-OH), the key sponsors in the Senate, and Chairman Tauzin (R-LA), Chairman Bilirakis (R-FL), Representative Greenwood (R-PA), and Representative Eshoo (D-CA), key advocates in the House."

Under the bill, drug companies will continue to receive requests from the Food and Drug Administration (FDA) to conduct needed pediatric drug studies in exchange for six months of additional market exclusivity for their products. In addition, the bill contains a series of improvements in the incentives, which were first enacted in 1997. The new law:

- Authorizes funding for the study of off-patent medicines, which are widely used by children but were not studied under the prior law;

- Requires prompt label changes by producers once pediatric studies are completed, and provides FDA with strong enforcement authority if changes are not made;

- Provides for wider dissemination of new information about the safety and dosing of drugs in children, so that pediatricians, parents, and others have access to the most current data;

- Encourages more studies of drugs for use in newborns, when needed and appropriate; and

- Creates an Office of Pediatric Therapeutics at the FDA to further enhance initiatives on behalf of children at the FDA.

The Chairman of the Board of the Foundation, Paul Glaser, testified to the Senate Committee on Health, Education, Labor, and Pensions in May that the law's demonstrated record of success in prompting new pediatric studies warranted its extension. In the seven years prior to enactment of the 1997 law, industry promised 70 pediatric studies but conducted only 11. In the three-and-a-half years since enactment, more than 400 studies have been planned, with the majority already underway. The Foundation worked closely with the American Academy of Pediatrics and other children's and health groups, to ensure the bill's passage.

The final version of the Best Pharmaceuticals for Children Act was approved by unanimous consent in both the House and Senate in December 2001. A prompt signature by the President was urgently needed because the incentives enacted in 1997 expired on January 1st. The new law expires in 2007.

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