On the other hand, since biosimilars will generally not be perfect substitutes for brand-name biologics, brand-name biologics will continue to be able to command high prices even after patent exclusivity ends; since innovator biologics will continue to generate revenues high enough to support. The bpcia took the former approach: it provided pioneer biologics with twelve years of data exclusivity starting from the time of fda approval more than twice as long as the analogous Hatch-Waxman exclusivity period for small-molecule drugs. . given that the Act has only been in place for two years, it remains to be seen whether or not policymakers made the right decisions. . Will the bpcia stand the test of time? . What potential issues could arise? This essay seeks to use lessons learned from the hatch-Waxman Act to comment on the bpcia. . Follow-on biologics represent uncharted territory for health care systems around the world; with very little precedent, it is hard to predict the societal impact of a facilitated biosimilars approval process and lengthy exclusivity periods for pioneer biologics. . by evaluating the politics surrounding the passage of the hatch-Waxman Act, as well as subsequent economic outcomes, i will project the impact of the bpcia and highlight areas of concern. .
Essay on, library and its, uses, complete, essay for Class 10, Class
For this reason, generic versions of biologics are more accurately described as follow-on biologics or synthesis biosimilars in the vast majority of cases, they are not quite the same molecule as the original biologic (the reference product). . bioequivalence as required by the hatch-Waxman Act is simply unrealistic8. . The complexity of biologics also makes them more expensive to develop and produce than small-molecule drugs; while the average small-molecule drug costs about 800 million, the average biologic costs over.2 billion to create. Given these differences between biologics and traditional drugs, the hatch-Waxman Act can no longer adequately address the needs of an evolving pharmaceuticals industry. . The standard of bioequivalence simply cannot apply to follow-on biologics. . The Acts patent term restoration terms do not account for the increased r d costs associated with developing complex biologics. . Reflecting the sentiments of professionals in the biotech and pharmaceutical industries, physicians, and insurers, the us senate resolved in September 2009 that Congress should build on the work of the hatch-Waxman Act and enact legislation to create a pathway for approval by the food and. In 2010, President Barack Obama signed into law the biologics Price competition and Innovation Act of 2009. . The bpcia, as it is commonly called, created a regulatory approval pathway for follow-on biologics while instituting data exclusivity for innovator biologics. . In doing so, it seemed to provide an answer to the debate over how biosimilars should be regulated. . On the one hand, biologics are much more difficult to produce than small-molecule drugs, and biosimilars are much less likely to be exactly similar than traditional generics; therefore, patent exclusivity should be extended and generic introductions slowed down. .
In the decades since the passage of the hatch-Waxman Act, there have been quantum leaps in scientific research7. . The traditional pharmaceutical industry seen declining revenue with the expiration of patent protection for several blockbuster drugs, the termination of drugs in later stages of development, and a dearth of new simple-molecule drugs in the research and development pipeline. . Major pharmaceutical companies must contend with the rapid growth of the generic industry, made presentation possible by the hatch-Waxman Act, in the face of global pressure to reduce costs. This breakdown of traditional big pharma has coincided with the rise of the biologics industry. . Between 20, sales of biologics more than doubled from 30 billion to 65 billion. . Crucially, biologics are very different from their small-molecule counterparts in their complexity and production methods. . While traditional pharmaceuticals can be made with straightforward industrial chemistry techniques and can be easily reverse-engineered, biologics are made by or from living cells, and the creative process can be both complex and unpredictable. . It is extremely difficult to copy proteins even small changes in the size of equipment used to manufacture biologics may cause the ultimate structures to have different functions. .
In a single stroke, it facilitated entry of biography generic drugs by creating a streamlined the approval process and essentially allowed for the formation of todays flourishing generics market. . due directly to the hatch-Waxman Act, generic drugs have expanded from nonexistence to a 70 billion market; in 2010, 78 of total prescriptions dispensed in the United States were for generic drugs. . The increased usage of generics, in turn, lowered overall prescription drug prices and increased patient access to drugs. . At the same time, the Act authorized extensions of market exclusivity for pioneer drugs beyond the lengths originally granted by the pto. . In doing so, it incentivized innovation and maintained a healthy pioneer pharmaceuticals industry alongside the newly surging generics industry. . over the last nearly three decades, the hatch-Waxman Act, despite a number of revisions, has worked well to balance innovation and access to prescription drugs. Today, however, the worldwide pharmaceutical industry is undergoing major change. .
For drug manufacturers, revenue comes from retail pharmacies, hospitals, physicians offices, and other medical institutions. . A complex and ever-evolving regulatory tangle governs this market. Prescription drug regulation aims to guarantee safety, quality, and access for the consumer, while promoting responsibility and innovation on the part of drug manufacturers. . In the United States, the patent and Trademark Office (pto responsible for granting patents, has traditionally played the role of spurring innovation while the food and Drug Administration (FDA) has sought to protect consumers from dangerous or ineffective products. . Before any drug can be marketed, it must first earn fda approval. . This requires a lengthy and expensive series of animal and human trials, along with a protracted application review period. . Legislative action throughout the last century has built these requirements on top of each other and expanded the fdas role as the gatekeeper for prescription drugs. The Drug Price competition and Patent Term Restoration Act of 1984, popularly known as the hatch-Waxman Act, altered the fda drug approval process and granted it additional powers in encouraging drug. .
Essay library and its uses - george Orwell: Politics and the
Despite paying more in medically-related expenses than any other writing developed nation, the us lags behind on key indicators of population health: it is 30th in infant mortality, 27th in life expectancy, and outside of the top 25 in physicians per capita2. Prescription drugs are an important part of that health care spending. . They make up more than 11 of overall health care expenditures in the United States at 307 billion, drugs are the third largest category of expense behind hospital and physician care3. . This can actually be a good thing drugs are a powerful substitute for many more expensive health treatments. . For this reason, more efficient health care systems often spend a larger portion than the us does on prescription drugs. . Japan, for example, spent.4 of its health care budget on prescription drugs in 20034. . Most other countries also pay less for their drugs in 2008, the 30 most commonly prescribed drugs were three times as expensive in the United States as they were in New zealand5. .
The United States health care system needs to be fixed, and improving the usage and regulation of prescription drugs can be a major part of that solution. Before devising the solution, it is important to understand the system. . The prescription drug industry is vast and multifaceted. . It is made up of two major types of producers: innovator plan and generic manufacturers. . Innovator (or pioneer) firms invest millions of dollars in pharmaceutical research and development to engineer entirely novel drugs6. . Generic firms invest significantly less in r d; instead, they reverse engineer molecules discovered and patented by innovator firms to produce cheap, unbranded versions of drugs. . Both types of drugs are prescribed by physicians and paid for in a number of different ways: out of pocket by the patient himself, with the help of public insurers like medicare, or with the help of private insurers. .
In order to explore the capacity of local communities to address unsustainable human consumption of renewable natural resources, i worked with the Environmental Advisory council as well as with the Transition Town group in Media, pennsylvania to estimate medias Ecological footprint. The Ecological footprint measures human consumption contrasted against the capacity of biologically productive land on the planet to regenerate the resources required to satisfy human consumption. Reconstructing the historical Case for Nondomestic Citation: The reconstruction And The supreme courts Consideration Of Foreign And International Law. Richard tao, this Article produces new historical evidence in relation to the ongoing debate surrounding the supreme courts consideration of foreign and international law. Specifically, the piece examines the legislative history of the Thirteenth and fourteenth Amendments—in addition to the history of other executive and legislative measures from the reconstruction period, including the civil Rights Act of 1866—in search of evidence relevant to the judiciarys consideration of non-domestic norms.
The importance of such an inquiry stems from the fact that little, if anything, has been said about the relevance of the reconstruction to the courts invocation of foreign and international law—a surprising fact given the eras intimate relation to the legal measures most often. As the records suggest, lawmakers fromthe period were indeed aware of non-domestic norms, having regularly turned to foreign and international law for inspiration and guidance. More directly pertinent to the current debate concerning non-domestic citation, it appears that at least some reconstruction legislators also expressly intended for future jurists to—at least in certain circumstances—consider foreign and international law while interpreting the periods statutes and amendments. Regulating biosimilars in the United States: Applying Lessons from the hatch-Waxman Act to follow-On biologics. Kevin ho, introduction: It is common opinion that the American health care system needs fixing. . The United States has little to show for spending.6 trillion each year on health care 8,402 per capita and nearly 18 of gdp1. .
Essay : library and its uses
On the fuller one hand, closed communities are necessary for democratic accountability and civic solidarity; but on the other hand, such boundaries may inhibit the achievement of global distributive justice. I discuss these issues and elaborate a theory of regional write governance that allows low-income societies to realize democracy and development, and thereby also global distributive justice. Media footprint Project footprint Estimates for the borough of Media and Policy recommendations for footprint Reduction. Justin Wright, transition Town Media began when a small group of people gathered to prepare their local community to confront the dual stresses of climate change and depleting petroleum reserves (peak oil). Part of the broader Transition Town movement, Transition Town Media seeks to address a wide array of resource management challenges. Humans are consuming natural renewable resources at a rate faster than they can regenerate. For a number of reasons, international solutions, to this problem are currently unfeasible.
The Freedom of Fantasy. Josh Cohen, this paper investigates the moral the status of pornography: is it coercive speech that deserves restriction, or representation of sexual fantasy that deserves protection? . Although the claim that pornography subordinates and silences women demands consideration and respect, it does not show that pornography itself is wrong. . Instead, consideration of pornographys role in the creation, exploration, and expression of sexuality shows that it should not only be protected, but also be encouraged to develop in progressive directions. Managing Globalization, realizing Democracy, and Achieving Distributional Justice: a theory of Regional governance for the Global south Sarah Goff. Sarah Goff, the most prominent theorists of supra-national governance, david Held and Jurgen Habermas, both argue that meeting the challenges of globalization requires new levels of democratic governance that supersede the nation-state. I find their empirical analysis of the challenges of globalization valuable, as it is more likely to provoke beneficial changes to the international political order than a purely normative argument. . However, there is a need to integrate the normative goal of greater social justice into a theory of supra-national governance, and it is in this integration that Held and Habermas run into difficulties. The question of how to draw the boundaries of supra-national political communities is central to my critique.
i provide an overview of Vaclav havels political foundation in moral principles, and examine whether his approach is applicable to decision-makers in office as well as those in the opposition. Institutional Autonomy and Economic development in Adverse Structural Conditions: The case of Two Arab Cities in Northern Israel. Harris Eppsteiner, arab citizens of northern Israel have consistently fared worse economically than Jewish Israelis, despite living in communities separated by only a few miles. Much of this economic disparity is due to structural factors that have constrained economic development in Arab communities, including discriminatory state economic policy. Despite these structural barriers to development, the city of nazareth has managed to achieve a fair degree of economic growth and modernization, especially when compared to the nearby city of sakhnin. This essay attempts to explain the divergent economic trajectories of the two cities, arguing that nazareths success can be attributed largely to the greater educational level of its population and to greater institutional autonomy relative to sakhnin in pursuing development projects. The results of this analysis have broader implications for processes of economic development under constraints that inhibit progress on the local level. Is Pornography a moral Problem?
The library has developed a suite of software tools (external link) that support the creation and validation of bags, as well as tools to accelerate network transfers by splitting collections into multiple streams of data. Additionally, the library has produced a video about Bagit and data transfer. You are here, home » Publications, groping for Stones to Cross the river: Chinas Transition to a capitalist biography Economy. Patrick hamm, chinas economic growth since 1978 has been used by two competing schools of thought to vindicate their respective views on economic reform in socialist countries. Free market Theorists of Convergence argue that China is evidence for the primacy of orthodox market reforms in the transition from socialism to capitalism, whereas State Theorists of divergence maintain that China illustrates the superiority of heterodox state-led reforms. In this paper i argue that China grew because it pursued a set of distinctively experimental statist reforms which allowed for the gradual emergence of a dynamic market sector, as well as the construction of a segment of competitive large enterprises. I then propose a social structural explanation of why this particular reform path was chosen. Both arguments are tested in an analysis of the transitional trajectories of four Chinese economic sectors: automobiles, electronics, oil, and banking.
Essay writing on library in kannada language
July 23, 2009 - d-lib Magazine has published an essay titled, 21st Century Shipping: Network data Transfer to the library of Congress (external link) in its July/August 2009 issue. Mike ashenfelder, a digital Media project coordinator in the national Digital Information Infrastructure and Preservation Program, writes about how the library uses network technology to transfer digital collections over the internet. Different Components of the network can Create data bottlenecks and Impede data Flow. Network data transfer is quicker, more efficient and more cost-effective than shipping paper data on hardware. Transfers that may take weeks on hardware, including shipping time and human labor, may take only hours over the network. The library is simplifying and standardizing the process so that any institution, sending any type or amount of data, can easily move their content over the network using open-source tools. The library, together with the, california digital Library (external link), created the, bagIt specification (pdf,.9KB) to describe a standardized, simplified digital container - - a "bag" - - in which to ship data.