The Priority List
The first priority list consisting of off-patent drugs needing further study under the BPCA Program was published in 2003 in the Federal Register (FR Vol. 68, No. 13: Tuesday January 21, 2003: 2789–2790). The list was updated annually through 2006. After the BPCA reauthorization in 2007, a revised priority list of needs in pediatric therapeutics was published in 2009 (FR Vol. 74, No. 70; Tuesday, April 14, 2009: 17203–17205).
The BPCA priority list consists of key therapeutic needs in the medical treatment of children and adolescents. The list is organized by therapeutic area, which can be a group of conditions, a subgroup of the population, or a setting of care. Each calendar year, a few therapeutic areas are selected for discussion and further prioritization (see sections BPCA Annual Meetings and BPCA Working Groups and Conference Calls below for more details).
In transitioning from prioritizing therapeutic needs, several changes have been implemented over the last 2 years in refining the prioritization process. The revised process includes:
- A systematic approach with clear objectives and outcomes
- Well-defined, objective criteria that are mutually exclusive and of a manageable number
- A dynamic process, including transparency, stakeholder input, and leadership
- Expert involvement to inform and contribute to the process.