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 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. .
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This requires a network 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. . In a single stroke, it facilitated entry of 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. .
It is made up of two major types of producers: innovator 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. . 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 supermarket 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. .
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 revelation 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. .
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. . Despite paying more in medically-related expenses than any other 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. .
The Global Water Crisis - running Dry
On the one emory 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 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. In order to explore the capacity of local communities to address unsustainable human consumption of renewable natural resources, administration 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.
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 Freedom of Fantasy. Josh Cohen, this paper investigates the moral 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.
The national orgy of mawkishness that followed the
The results provide strong support for the proposed explanations, and also permit some insight into the nature of Chinas economic system, and the direction in which it is headed. Havels Art of the Impossible: a critique matt Sherwin. Matt Sherwin, i provide an overview of Vaclav havels political thesis 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 impact of floods on policy and politics, by matteo tacconi ; Abracadabra of democracy promotion through development aid, by maciej kuziemski and expert debate: Ibolya bárány (hu igor Blaževič (cz tomicah Tilleman (us marcin Wojciechowski (pl karla wursterová (sk an analysis of the central. For full content (print/electronic formats) please visit. You are here, home » Publications, groping for Stones to Cross the river: Chinas Transition to a capitalist 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 homework 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.
of the czech Republic) talk about Ukraine in the central European perspective and. Michael Sandel (Harvard University Professor of Philosophy) discusses the need for idea of solidarity in liberal democracy. Read the best of analysis, opinion, and essays selected by accomplished editors from the czech Republic, hungary, poland, and, slovakia. Visegrad Insight aims to provide a platform for high profile debate on cooperation among Central European governments, businesses, and communities, and the challenges they face. Highlights, zoltán Cséfalvay (State minister for Strategic Affairs, ministry of National Economy, hu agnieszka jucewicz-Kwaśniewska (Editor-in-chief of, gazeta wyborcza s womens weekly, wysokie obcasy, pl jakub Klepal (Executive director of the forum 2000 foundation, cz) and. Ivan mikloš (Former Minister of Finance, sk) predict how we will take care of our elderly and ourselves when the welfare state fails ; Policy recommendations on the welfare state crisis and baby doom from. Martin Ehl and, olga Urbańska ; Interviews on Ukraine and Central Europe with. Adam Michnik and, karel Schwarzenberg ; Michael Sandels essay on the idea of solidarity; rivers of Empathy.
When we couple this incident with the incendiary language found in the national discourse at the moment, he continued, it is time to take stock of the climate of race and diversity within our district and throughout our town. The solidarity family gathering will be held on the grounds of the town Hall Green, 525 Washington. 28, from 4 to. Families are encouraged to bring a blanket and a meal and join together to meet new friends. According to a flier for the event, the event will end with a brief program offering words of peace and solidarity as the new school year begins. Jennifer Fenn Lefferts can be reached. After the welfare State, the fourth issue of, visegrad Insight, discusses the question of how we will take care after each word other in the future. We publish a policy memo by martin Ehl on the future reforms of welfare state and an expert debate about development aid that is funded by V4 countries that has risen to almost usd 1 bln last year.
Civil Rights movement :, national, humanities Center
In response an online incident last month in which Wellesley school students participated in hate speech, the school district has formed a group with staff, students, parents and others in the community to attempt a dialogue about race and diversity. In a series of Facebook messages that surfaced in July, students at Wellesley high School and elsewhere used racial and homophobic slurs and made jokes about lynching and genocide. Screenshots of the messages were provided to the Globe by a wellesley high School student. In a recent message to the community, superintendent david Lussier paper said the group will meet throughout the year to plan activities, including a solidarity family gathering with the pro-diversity world of Wellesley organization before the school year starts. It would be easy to minimize this unacceptable activity as merely the bad choices of a few students, he said. If the language of hate can be used casually and without consequence, what would that say about our community? Get Today's headlines in your inbox: The day's top stories delivered every morning. Thank you for signing up! Sign up for more newsletters here.