Reference pricing for drugs: is it compatible with U.S. health care?
(25/276)
To control spending on prescription drugs, health insurance systems abroad have experimented in recent years with a novel form of patient cost sharing called "reference pricing." Under this approach, the insurer covers only the prices of low-cost, benchmark drugs in therapeutic clusters that are deemed to be close substitutes for one another in treating specific illnesses. Patients who desire a higher-price substitute in a cluster must then pay the full difference between the retail price of that drug and the reference price covered by the insurer. This paper explores the difficult trade-offs that policymakers must make in designing such a system, drawing where relevant from experience abroad. (+info)
Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
(26/276)
The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes. (+info)
Molecular characterisation of the 22q13 deletion syndrome supports the role of haploinsufficiency of SHANK3/PROSAP2 in the major neurological symptoms.
(27/276)
METHODS: The 22q13 deletion syndrome (MIM 606232) is characterised by moderate to profound mental retardation, delay/absence of expressive speech, hypotonia, normal to accelerated growth, and mild dysmorphic features. We have determined the deletion size and parent of origin in 56 patients with this syndrome. RESULTS: Similar to other terminal deletion syndromes, there was an overabundance of paternal deletions. The deletions vary widely in size, from 130 kb to over 9 Mb; however all 45 cases that could be specifically tested for the terminal region at the site of SHANK3 were deleted for this gene. The molecular structure of SHANK3 was further characterised. Comparison of clinical features to deletion size showed few correlations. Some measures of developmental assessment did correlate to deletion size; however, all patients showed some degree of mental retardation and severe delay or absence of expressive speech, regardless of deletion size. CONCLUSION: Our analysis therefore supports haploinsufficiency of the gene SHANK3, which codes for a structural protein of the postsynaptic density, as a major causative factor in the neurological symptoms of 22q13 deletion syndrome. (+info)
The WTO's balancing act.
(28/276)
The 146 member nations of the World Trade Organization recently came to an agreement that will allow poor nations to avoid patent restrictions and import generic versions of urgently needed medicines, but this accord has been met with criticism from international aid organizations. What effects will this agreement have on reducing the burden of disease in the developing world, and also on the pharmaceutical industry? (+info)
Genetic counselors: translating genomic science into clinical practice.
(29/276)
In a time of emerging genetic tests and technologies, genetic counselors are faced with the challenge of translating complex genomic data into information that will aid their client's ability to learn about, understand, make, and cope with decisions relating to genetic diagnoses. The first of two companion articles in this issue examines the role of the genetic counselor, particularly in counseling individuals at risk for or diagnosed with breast cancer, in an era of high-tech health care and gene patents. (+info)
Yeast as a touchstone in post-genomic research: strategies for integrative analysis in functional genomics.
(30/276)
The new complexity arising from the genome sequencing projects requires new comprehensive post-genomic strategies: advanced studies in regulatory mechanisms, application of new high-throughput technologies at a genome-wide scale, at the different levels of cellular complexity (genome, transcriptome, proteome and metabolome), efficient analysis of the results, and application of new bioinformatic methods in an integrative or systems biology perspective. This can be accomplished in studies with model organisms under controlled conditions. In this review a perspective of the favourable characteristics of yeast as a touchstone model in post-genomic research is presented. The state-of-the art, latest advances in the field and bottlenecks, new strategies, new regulatory mechanisms, applications (patents) and high-throughput technologies, most of them being developed and validated in yeast, are presented. The optimal characteristics of yeast as a well-defined system for comprehensive studies under controlled conditions makes it a perfect model to be used in integrative, "systems biology" studies to get new insights into the mechanisms of regulation (regulatory networks) responsible of specific phenotypes under particular environmental conditions, to be applied to more complex organisms (e.g. plants, human). (+info)
Inside the triple helix: technology transfer and commercialization in the life sciences.
(31/276)
The transfer and subsequent application of academic research results has demonstrable benefits for health care, researchers, universities, companies, and local economies. Nonetheless, at least three general concerns exist: bias in the reporting of results, limited revenues from these activities, and the lack of data to evaluate technology transfer activities. Future efforts with regard to technology transfer in the life sciences will need to recognize its importance without ignoring concerns or overestimating benefits. Next steps include better monitoring of university-industry relationships, the development of a better data system, the dissemination of best practices in technology transfer management, and evaluation of national technology-transfer policies. (+info)
Interactions between patent medicine vendors and customers in urban and rural Nigeria.
(32/276)
Patent medicine vendors (PMVs) supply a large portion of the drugs used by the public in African countries to treat their illnesses. Little has been reported about what actually transpires between PMVs and their customers, but nevertheless, concerns have been raised about the potential for abuse of their position. This study conducted 720 observations of PMV-customer interaction in 444 medicine shops in both the metropolis of Ibadan and the rural town of Igbo-Ora in Oyo State, Nigeria. Each interaction lasted 2 minutes on average. A quarter of the customers shared their illness problems with the shop attendant, 9% presented a prescription and the majority simply requested items for purchase. Most customers (73%) were buying drugs for themselves, while the remainder had been sent to purchase for another person. The former were more likely to be adults, while the latter were more often children and adolescents. The most common PMV behaviours are: selling the requested medicine (69%), giving their own suggestions to the customer (30%), asking questions about the illness (19%) and providing instructions on how to take the medicine (21%). Only three referrals were observed. The large number of specific drug requests was evidence of a public that was actively involved in self-care, and thus the major role of the PMV appeared to be one of salesperson meeting that need. A second role became evident when the customer actually complained about his/her illness, a practice associated with the more active PMVs who asked questions, gave suggestions and provided information. These PMV roles can be enhanced through consumer education, PMV training and policy changes to standardize and legitimize PMV contributions to primary health care. (+info)