Prioritizing Pediatric Therapies

A primary function of BPCA is to prioritize needs in pediatric therapeutics. Additional research is needed on pharmacokinetics and pharmacodynamics of drugs in children, safety of drugs in children, dosing, and ultimately effectiveness.

The 2002 BPCA established a prioritization process for off-patent medications based on three major factors:

  • Availability of information concerning the safe and effective use of a drug in the pediatric population and the need for additional information
  • Potential health benefits in the pediatric population resulting from new studies
  • Possible need for reformulation of existing products

The law that reauthorized the BPCA in 2007 also revised the prioritization process to emphasize knowledge gaps in therapeutic areas, as opposed to knowledge gaps about specific drug products. The prioritization process was revamped in 2010 and continues annually. 

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