March 2012

Elizabeth Glaser Pediatric AIDS Foundation Applauds Institute of Medicine Report

March 1, 2012

Contact: Robert Yule, 202.390.9540,

March 1, 2012, Washington, D.C. – The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) today welcomed the release of the Institute of Medicine (IOM) report Safe and Effective Medicines for Children: Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are groundbreaking laws that require the study of drugs in children, and provide incentives for industry to create drugs that are safe and effective for pediatric use. Data resulting from BPCA and PREA studies are added to drug labels to give parents and health care providers essential information on the safety and efficacy of drugs used in children.

“The Institute of Medicine’s report highlights the incredible advances for children with HIV brought about by these important pieces of legislation, but also notes several areas of improvement that should be considered as Congress looks to reauthorize these laws,” said Dr. Laura Guay, the Foundation’s Vice President of Research.

BPCA was first passed by Congress in 1996, and PREA was passed in 2003. Both laws were reauthorized together in 2007, and are set to expire on October 1, 2012.

The following are among the report’s key findings and recommendations for BPCA and PREA reauthorization:

  • Pediatric studies conducted under BPCA and PREA have provided important new data on drug efficacy and safety in children, resulting in more than 400 drug labeling changes;
  • Pediatric studies should be planned, initiated, and completed earlier to benefit children;
  • Delays in the completion of FDA-mandated studies warrant further attention;
  • More information is needed in pediatric drug use among neonates (infants younger than 28 days); and
  • Continued, increased transparency is needed to improve access to important information from pediatric studies.

For children with HIV, it is especially crucial to have the correct dosing information for antiretroviral drugs (ARVs). Over-dosing children can cause the ARVs to become toxic, but under-dosing can lead to the development of resistance, which in some cases can lead to resistance to an entire class of drugs. This can prove fatal due to the already limited classes of HIV drugs currently available for children.  

“There are still many uncertainties when it comes to labeling for HIV drugs, especially for our youngest children,” said Dr. Guay. “Strengthening these laws would improve upon the advancements we have already seen, and ensure that children continue to be prioritized in terms of research and drug development, especially as the next generation of HIV drugs is developed.”  


About the Elizabeth Glaser Pediatric AIDS Foundation:
The Foundation is a global leader in the fight against pediatric HIV and AIDS, and has reached more than 13.6 million women with services to prevent transmission of HIV to their babies. It currently works at more than 5,900 sites in 16 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute strategic and targeted global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide. For more information, visit