9/20/2007

Contact: Robert Yule
202-448-8456
ryule@pedaids.org

Washington, D.C.—The Elizabeth Glaser Pediatric AIDS Foundation today applauded the passage of drug safety legislation by the U.S. Senate that will improve the health of countless children across the nation. The Food and Drug Administration Amendments Act of 2007 overhauls the drug safety system and contains several provisions to make medicines and medical devices safer for use in children.

“Congress has taken another big step toward leveling the playing field for children’s health,” said Pamela W. Barnes, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. “This landmark legislation will help prevent kids from being left out of cutting-edge medical advances.”

Children have long stood at the back of the line in terms of drug research. Approximately 75 percent of all drugs prescribed for children have never been tested for pediatric use. The legislation renews the FDA’s authority to require the testing of new drugs for use in children and continues the use of financial incentives for drug makers to test their products for children.

“When it comes to proper dosing, children are not just little adults,” said Barnes. “Drugs behave differently in their developing bodies. The programs in this legislation help guarantee that when the FDA approves a drug for adult use, it will also be studied for children.”

The Foundation recognized the champions of the pediatrics provisions in the bill, Sens. Christopher Dodd (D-Conn.), Hillary Clinton (D-NY), and Reps. Anna Eshoo (D-Calif.), Edward Markey (D-Mass.), and Mike Rogers (R-Mich.), whose leadership and efforts will ensure that children have better access to safe and effective medicines and medical devices. The Foundation also praised the sponsors of the broader FDA bill, Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.), and Reps. John Dingell (D-Mich.) and Joe Barton (R-Tex.).

The bipartisan legislation, passed yesterday in the House and today in the Senate, expands upon provisions enacted by Congress over the past decade that have dramatically increased the number of drugs tested and labeled for use in children. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) have addressed the gap in medicines for children by creating a highly successful “carrot-and-stick” mechanism to generate pediatric studies. BPCA provides incentives to manufacturers to conduct pediatric testing of drugs important to children, and PREA allows the FDA to require pediatric studies.

The Food and Drug Administration Amendments Act of 2007 renews and strengthens these important programs, and for the first time includes incentives to spur the development and safety-testing of medical devices for children. Most products are designed for adult bodies, and many function differently when used for children. The legislation strengthens incentives for companies to develop products for pediatric patients, while preserving the FDA’s ability to monitor the safety of new pediatric products once on the market. It also streamlines pediatric approvals and elevates the issue of pediatric devices among federal agencies.

Without congressional reauthorization, BPCA and PREA were set to expire on October 1. The Food and Drug Administration Amendments Act of 2007 renews and improves both laws, but fails to give children a permanent guarantee that medicines be studied for pediatric use, making this authority subject to renewal in 2012.

“Children shouldn’t have to lobby every five years for the fundamental right to safe medicines, a protection guaranteed permanently to adults,” said Barnes. “We look forward to working with Congress on future legislation to finally put children’s health on an equal footing with that of adults.”

The programs in this legislation have already given physicians important tools with which to treat children suffering from a variety of illnesses and conditions, from asthma to AIDS. They have resulted in more than 400 pediatric drug studies and 197 labels changed to include pediatric safety information. They have also led to more drugs being produced in formulations such as liquids and chewable tablets that children can more easily take.

“As adults, we wouldn’t use medicines or products that were not tested for us – so why would we give them to our children?” said Susan Belfiore, a mother of four HIV-positive children who has testified before Congress about the continuing need for pediatric drug studies.

Ten years ago, her daughter Mihaela’s health suffered while taking an HIV medication that had not been studied sufficiently for use in children. She was being under-medicated because doctors did not know what dose of the drug was the safest and most effective to give to children. As Mihaela became sicker, she also developed resistance to the medication, which took away another tool in the already limited arsenal to treat her HIV-infection.

“Today my daughter is healthy because she is taking medicine at the proper dosage that was tested specifically for kids. This is why the passage of this legislation is such an important victory for children everywhere.”

The Foundation has long been a leader in advocating greater pediatric testing of medications and devices for children to fight HIV/AIDS and other illnesses. To learn more, visit http://www.pedaids.org/YouCanHelp/Advocacy/ChildrensHealth.aspx.

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About the Elizabeth Glaser Pediatric AIDS Foundation
The Elizabeth Glaser Pediatric AIDS Foundation is a worldwide leader in the fight against pediatric AIDS. Our innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international prevention and treatment programs are bringing dramatic changes to the lives of children worldwide.