Paul Glaser to testify before Congress in support of incentives for the testing of drugs in children

Elizabeth Glaser Pediatric AIDS Foundation
Tuesday, 8 May 2001

Chairman of the Board of the Elizabeth Glaser Pediatric AIDS Foundation Comes to Washington to fight for the safety and efficacy of drugs for children.

Washington, D.C. - Tuesday, May 8, 2001 - Paul Glaser, Chairman of the Board of the Elizabeth Glaser Pediatric AIDS Foundation, testified before the Senate Health, Education, Labor and Pensions Committee today on Capitol Hill in support of the pediatric drug testing provision within the Food and Drug Administration Modernization Act of 1997 (FDAMA). The provision has successfully encouraged drug companies to test drugs for use in children by offering six months of additional exclusive sales on drugs studied for children.

"If you are a parent, and you find out your child is seriously ill, you want to know that the medications for that illness are safe and effective for your child," said Glaser, who lost his 7-year-old daughter, Ariel, to AIDS in 1988 at a time when life-prolonging AIDS drugs had not been tested for use in children. "Through this law, we have the power to ensure that the needed pediatric studies are conducted so that every child has the chance to live a healthy life."

Glaser testified that prior to the passage of this provision in 1997, 80 percent of the most commonly prescribed medications had never been tested for use by children. Without this critical data, doctors are often forced to rely on anecdotal information or guesswork when prescribing drugs for their pediatric patients. The results of this have sometimes been tragic. As recently as 1999, seven newborns who received the widely prescribed drug erythromycin became seriously ill and required surgery because the drug had not been tested in this age group.

In the six years prior to enactment of this law, the drug manufacturers promised 70 pediatric studies of marketed drugs but conducted only 11. In the three years since enactment of the law, more than 300 pediatric drug studies have been initiated. In a study for Congress, the FDA concluded that the incentives are "highly effective."

"Ultimately, we are here to take care of our most precious resource -- our kids," said Glaser. "And we can do that by agreeing here and now to reauthorize this important law. If allowed to expire, the trend of increased children's health and safety information experienced over the past few years will likely be reversed, resulting in a serious setback to children's health care."

In his testimony, Glaser applauded Senators Christopher Dodd (D-CT) and Mike DeWine (R-OH) for drafting a bill that reauthorizes the necessary pediatric testing provisions while including much-needed improvements in the law, including the study of generic medicines, prompt changes in safety and efficacy information upon the completion of studies, wider dissemination of study results, a stronger emphasis on studies of newborns and the creation of a new office of pediatric therapeutics to highlight the importance of pediatrics within the FDA.

But Glaser expressed concerns about the extent of the incentives for some top-selling drug products. "At the Foundation, we believe that a meaningful incentive must be maintained to ensure that the needed pediatric studies are completed, but we think that [Congress] should consider providing a cap or an 'excess profits clause' for blockbuster drugs. As to what the cap should be, or the best way to implement it, I don't pretend to have the answer -- we all need to continue discussion on this part."

"I am convinced that the policies of the Federal Government should always protect children's health care," said Glaser. "In a system such as ours, where those with power and money often get the most attention, there has historically been too weak a voice on behalf of our children. The law that [Congress] passed in 1997 has been a resounding success, and we now have the opportunity to build on that success."

The Elizabeth Glaser Pediatric AIDS Foundation is the leading worldwide nonprofit organization dedicated to identifying, funding, and conducting pediatric HIV/AIDS research as well as promoting global education, awareness and compassion about HIV/AIDS in children.

In addition, the Foundation is committed to working on other serious and life-threatening diseases facing children through the newly created Glaser Pediatric Research Network. The Network brings together five of the nation's pre-eminent academic medical centers in an unprecedented collaboration that will accelerate better treatments for seriously ill children, help train the next generation of pediatric clinical investigators, and serve as a united voice to advocate policies that improve children's health worldwide.

Since 1988, the Foundation has raised more than $120 million to ensure that children are at the forefront of every scientific breakthrough.

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