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The Tufts Center for the Study of Drug Development conducts research on a broad range of topics in the areas of drug development, regulation, and utilization. Current research projects are grouped as follows:
Evaluating the Impact of Prescription to Over–the–Counter Switches Using a Decision–Analytic Model
Cohen JP (in progress)
We have developed a decision–analytic model to estimate the costs, benefits, and risks associated with switching prescription drugs to over–the–counter. We first used the non–sedating antihistamine loratadine as an example in our analyses. We then followed with the proton pump inhibitor, omeprazole, and the statin, simvastatin. Tufts CSDD publications related to this project have appeared in the British Medical Journal [2005] and the American Journal of Therapeutics [2003].
The model we have developed can be used to analyze the impact of other potential prescription to over–the–counter switches, including levonorgestrel, lovastatin, and orlistat.
Evolution Along the Government–Governance Continuum: Impacts of Fast Track and Orphan Product Programs on Innovation
Milne CP, Tait J, Cabanilla L, Wegner J (in progress)
Focus of this project is to examine FDA regulatory programs as examples of government evolving towards governance approach (bottom–up instead of top down, involves policy networking) to regulatory policy in order to encourage innovative R&D of products for unmet medical needs in therapeutic areas with high entry barriers. Paradoxically, the methods employ more, rather than less, intervention from the top down, but of a cooperative, rather than coercive nature, facilitating problem–solving between policy targets and policy makers. The Orphan Product and Fast Track Programs were chosen as exemplars because they fit the description of governance approach to regulatory systems and because of their broader application as vehicles for encouraging innovation in areas of R&D that have significant public health risks, account for significant investment of public funds in R&D, and require transparent and comprehensive oversight processes to establish and maintain public confidence. This project is being conducted jointly with the Innogen Centre at the University of Edinburgh in Scotland.
This project will provide a practical application of emerging theories of government from the social sciences regarding the prerequisites for regulatory systems that can support competitiveness in high–tech industries while maintaining public confidence.
International Formulary Management (Reimbursement) Comparisons
Cohen JP (in progress)
This series of studies analyzes the role of cost–effectiveness analysis in US and European formulary development and reimbursement practices. First, we are analyzing technology appraisals published by the British National Institute for Clinical Excellence (NICE), comparing NICE reimbursement recommendations regarding 71 recently approved drugs with reimbursement decisions made by 15 US insurers and pharmacy benefit managers. This analysis examines the impact of formulary management on patient access to recently approved pharmaceuticals in the US and UK. Second, we are examining patient access to the global list of 100 top–selling drugs, in the US, UK, France, and the Netherlands. Third, we are analyzing the numbers of first–in–class and follow–on drugs, as well as original and follow–on indications, on the World Health Organization’s Essential Drug List.
Three studies are in press at the European Journal of Health Economics, Applied Health Economics and Health Policy, and the Journal of Clinical Pharmacy and Therapeutics. Two more studies have recently been submitted for publication. And two publications have recently appeared in the Regulatory Affairs Journal [2005] and the International Journal of Technology Assessment in Health Care [2004].
These studies are funded in part by the European Commission / Dutch National Science Foundation as part of a project examining differences in the role that cost–effectiveness and budget impact play in formulary development and reimbursement decisions.
Tracking the Progress of FDAMA’s Pediatric Studies Initiative
Milne CP, Fadan L (in progress)
This is a multi–phase project. The initial phase was a survey of pharmaceutical company sponsors who received the first 40 written requests to conduct studies for pediatric exclusivity. The objective was to assess the effectiveness of the implementation of the pediatric exclusivity provision. The findings from this phase were published [Milne C–P. Exploring the frontiers of law and science: the FDAMA’s pediatric studies initiative. Food and Drug Law Journal 2002;57(3):491–517] and have contributed to the ongoing debate on the codification of the pediatric rule. Another phase of the project analyzed the present and possible future impact of the pediatric studies incentive on four areas of concern: pediatric public health; the pediatric research infrastructure; unforeseen consequences; and the cost–benefit ratio. The findings were published as a white paper [Milne C–P. White paper: the pediatric studies incentive: equal medicines for all. Boston: Tufts Center for the Study of Drug Development, April 2001] and incorporated into the briefing materials for the U.S. House and Senate Committee hearings on reauthorization of the pediatric exclusivity provision of FDAMA (i.e., the Best Pharmaceuticals for Children Act). A follow–up report on the economic and therapeutic impact of the pediatric studies incentive program was published in the summer of 2005 [Kaitin KI, editor. U.S. pediatric studies incentive led to new labeling for nearly 100 drugs. Tufts Center for the Study of Drug Development Impact Report 2005 Jul/Aug;7(4)]. A follow–up survey of biopharmaceutical firms, which have received written requests for pediatric studies from FDA, is currently underway and results will be published in spring 2007.
Tufts CSDD is the only source of objective data on the policy implications of this important public health initiative.
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