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Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U.S. Food and Drug Administration (FDA) approved a commercial version of 17P (trade name "Makena") through their Accelerated Approval Program, and the price of 17P subsequently increased by nearly 100-fold. This approval was largely based on a methodologically limited, placebo-controlled trial, which found that although 17P significantly reduced preterm births, the placebo group had significantly more participants with a history of preterm birth, potentially confounding the results. The FDA required a confirmatory trial for continued approval that demonstrated clinical benefit. Eight years after accelerated approval, the confirmatory trial, PROLONG (Progestin's Role in Optimizing Neonatal Gestation), found no evidence of an effect of Makena for reducing recurrent preterm birth or perinatal mortality. Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth. Although the FDA created the Accelerated Approval Program to introduce therapies for serious conditions that lacked treatment options, Makena is an example of the limitations of this program. We encourage the FDA to re-evaluate their program and consider improvements, such as shorter timeframes to complete confirmatory trials, potentially revoking approval if the studies are not completed within a predefined timeframe, and to hold manufacturers responsible, in part, for the costs of therapy if they cannot prove a clinical benefit.

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Purpose Engagement in policy is an essential public health service, with state legislatures serving as important arenas for activity on issues affecting children and families. However, a gap in communication often exists between policymakers and public health researchers who have the research knowledge to inform policy issues. We describe one tool for researchers to better leverage public health research to inform state legislative policymaking on issues of relevance to children and families. Description The Oregon Family Impact Seminar (OFIS), adapted from the Policy Institute for Family Impact Seminars, applies a systematic process to bring a synthesis of research findings on public health issues to state legislators using a six-step process: (1) identify candidate topics, (2) recruit legislative champions, (3) select the topic, (4) identify and prepare speakers, (5) host the presentations, and (6) develop and disseminate a research brief as a follow-up contact. Assessment Use of this model in Oregon has produced policy impact; for example, the 2015 presentation, "Two-Generation Approaches to Reduce Poverty," prompted ongoing dialogue culminating in a new statute to increase Earned Income Tax Credit for parents with young children. This approach also has strengthened relationships among researchers and legislators, which serves to streamline the OFIS process. Conclusion This model is an effective vehicle for leveraging public health research findings to inform state-level policy. This model also serves to connect researchers with opportunities to engage with policymakers to address significant public health problems, particularly those addressing social, economic, and environmental determinants of health for children and families.

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Youth in foster care experience major deficits on standardized measures of academic functioning, are at high risk of academic failure, and are more likely than their non-foster peers to be disciplined at school. School discipline-related problems increase risk of problematic educational and behavioral outcomes including dropping out of school, repeating a grade, and engagement in delinquent and criminal behavior. Identifying which youth are at greatest risk for experiencing school discipline is needed in order to improve the educational experiences of youth in foster care. The current investigation examined the effects of youth and contextual characteristics on school discipline events among 315 youth in foster care. Results revealed that being male, in a higher-grade, and a student of color, living apart from one's sibling, and school mobility significantly predicted discipline events. An additional statistical model divided youth into groups based on race, sex, and disability status taking into account the multiple identities youth have. These results suggest that gender, race, and disability status cumulatively inform school discipline experienced among youth in foster care.

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This paper introduces a flowchart-based methodology for describing the movement of foster youth in and out of placements of differing types and durations. This longitudinal methodology is designed to be sufficiently simple to appeal to policymakers and administrators seeking to chart the movement of groups of youth over time and the sequencing of their placements, and sufficiently descriptive to be of use to researchers seeking to predict the placement trajectories of subgroups of foster youth. The paper provides an example of the use of the method drawing upon state administrative data from a large study of preadolescent and adolescent youth in foster care situated in Oregon. Implications for the application of the methodology to different issues of interest to researchers, policymakers, and administrators are discussed.