OPPTB aims to assure that there are safe and effective therapeutics for children and pregnant and lactating women and that these medications are used optimally according to individual needs.
The branch promotes basic, translational, and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceuticals. It is responsible for developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, lactation, infancy, childhood, and adolescence using evidence-based therapeutic approaches. This includes expanding the genomic understanding, phenotypic characterization, and use of advanced ’omics technologies to inform prevention and treatment strategies. The goal of these efforts is to assure that medications are appropriately tested for dosing, safety, and effectiveness for individuals within their target populations.
Multiple gaps in knowledge regarding the use of therapeutics in children and pregnant and lactating women have led to inadequate labeling and frequent off-label use of prescription drugs. One of the branch's major activities is implementation of the Best Pharmaceuticals for Children Act (BPCA). The BPCA legislation promotes the prioritization of off-patent drugs and therapeutic areas that need further study in pediatrics and allows NICHD to sponsor clinical research of the prioritized therapeutics and disseminate results to improve drug labeling.
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- Pediatric Pharmacology Training in the United States: At the most recent T32 Fellows' meeting, OPPTB's Dr. George Giacoia discussed NICHD's efforts to enhance the pediatric pharmacology program through effective collaborations and innovative research projects.
- 2019 BPCA Stakeholders Meeting : OPPTB held a stakeholder meeting/webinar on March 22, 2019. The meeting’s goals were to: provide an update on current studies, recent label changes, and scientific advances of the BPCA program; identify continuing gaps in pediatric drug development in select therapeutic areas; and discuss the program’s scientific direction.