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 reauthorization of 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 further refined in 2010 to emphasize the following four principles:
- Prioritization must be a well-defined process that includes a systematic approach and clear objectives and outcomes.
- The process must have well-defined objectives and criteria for measuring priority, and these objectives must be mutually exclusive (not overlap) and of a manageable number.
- Prioritization must be a dynamic but legitimate and fair process that incorporates transparency, stakeholder input, and strong leadership.
- Prioritization must involve experts to inform and contribute to the process and add credibility to the outcomes.