population, children are protected from participation in studies, and there is little commercial motivation to test drugs in children.

Surveillance

Dr. Murphy stressed that, because pediatric drugs are studied in a very limited population in a very defined way, a great deal of the safety information on these products emerges only after they have been marketed. Her call for the collection of data on long-term outcomes, with better postmarket safety surveillance, was echoed throughout the meeting. Dr. Snodgrass asserted that postmarket surveillance must be more extensive and thorough than is the case today. It needs to encompass adverse events as well as other outcomes and to quantify long-term benefit. Dr. Fleischman suggested that the only way to make postmarket surveillance feasible is to support the development of uniform electronic medical records with appropriate privacy protections.

Regulation

Dr. Murphy also suggested combining incentives and requirements for conducting research in pediatric populations into one process, as the Europeans have done. In the United States, the two are handled separately in the legislative process and within the U.S. Food and Drug Administration (FDA). Summaries of research should be available to the public for studies that fall under both the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). How much information would be provided and in what format would have to be determined. Dr. Nelson suggested that Written Requests should be made public, as knowing what the FDA is asking a sponsor to do is helpful in evaluating what the sponsor has actually done.

Ms. Ireland seconded the call for greater transparency, adding that there is also a need for better coordination of studies done under PREA and BPCA. She suggested that there is no reason why the Pediatric Advisory Committee reviews adverse events for BPCA and not for PREA studies. In addition, Ms. Ireland favors looking beyond pediatric-specific laws to the broader movement in Congress to address drug safety issues. The Senate Health, Education, Labor, and Pensions (HELP) Committee is exploring the idea of broadening the authority of the FDA to require postmarket studies and is considering the development of a clinical trials database.

According to Dr. Ward, the PREA requirement that pediatric studies be requested only for those indications applied for in adults is too limiting. Multiple examples can be cited in which new therapeutic uses have



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