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Incentives For Orphan Drug Research And Development In The United States, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, Sheryl Szeinbach, Jay Visaria
Incentives For Orphan Drug Research And Development In The United States, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, Sheryl Szeinbach, Jay Visaria
Rosa Rodriguez-Monguio
Background The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Methods Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study …
Drug Utilization And Cost In A Medicaid Population: A Simulation Study Of Community Vs. Mail Order Pharmacy, Rosa Rodriguez-Monguio, Satish Valluri, Enrique Seoane-Vazquez, Sheryl Szeinbach
Drug Utilization And Cost In A Medicaid Population: A Simulation Study Of Community Vs. Mail Order Pharmacy, Rosa Rodriguez-Monguio, Satish Valluri, Enrique Seoane-Vazquez, Sheryl Szeinbach
Rosa Rodriguez-Monguio
Background Outpatient drugs are dispensed through both community and mail order pharmacies. There is no empirical evidence that substitution of community pharmacy with mail order reduces overall drug expenditures. The need for evaluating the potential effects on utilization and costs of the possible extension of mail order services in Medicaid provides the rationale for conducting this study. This study compares drug utilization and drug product cost in community vs. mail order pharmacy dispensing services in a Medicaid population. Methods This study is a retrospective cohort study comparing utilization and cost patterns in community vs. mail order pharmacy. A simulation model …