The Off-Patent Priority List

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in consultation with the U.S. Food and Drug Administration (FDA), developed the following process for prioritizing off-patent drugs, to identify those for which data are needed immediately, and those for which data can come later. In general, this process is as follows:

1. Determine the availability of appropriate formulations for pediatric populations.
2. Stratify according to FDA review divisions.
3. Screen within each group to select high-priority drugs (completed by experts from NIH Institutes, professional societies, pediatric pharmacology, and pediatric subspecialties).
4. Conduct a literature review of published studies.
5. Review frequency of use, availability of other drugs in the same therapeutic group, and public health benefit of studying the drug (conducted by FDA review divisions).
6. Prioritize within therapeutic groups and between drug groups, accounting for: similar drugs, frequency of use, cost, therapeutic index, use in life-threatening situations, physician preference, patient factors, and indications for use.