|Topic:||Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts|
THE NATIONAL ACADEMIES
Institute of Medicine
Board on Health Sciences Policy
Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA)
and the Pediatric Research Equity Act (PREA)
Monday, February 27, 2012
104 The Keck Center of the National Academies – 12:45 p.m.
728 Hart Senate Office Bldg. – 2:00 p.m.
428 Hart Senate Office Bldg. – 3:00 p.m.
Safe and Effective Medicines for Children:
Pediatric Studies Conducted Under the Best Pharmaceuticals for Children
and the Pediatric Research Equity Acts
Congress sought to boost research on the safety and effectiveness of drugs in pediatric patients through legislation providing economic incentives and adding requirements for such studies. As requested in P.L. 110-85 and P.L. 111-148, this report asks the Institute of Medicine to provide an independent assessment of several aspects of the studies carried out under legislation, including the ethical challenges of conducting studies on children, the extent to which information can be extrapolated from studies involving adults, and labeling changes that have occurred as a result of this research.
These series of briefings were for members of Congress and congressional staff only. The report was publicly released on February 29, 2012 and can be found, in its entirety, on the Web site of the National Academies Press.