Senior Essay Library

Groping for Stones to Cross the River: China’s Transition to a Capitalist Economy
Patrick Hamm
China’s 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. The results provide strong support for the proposed explanations, and also permit some insight into the nature of China’s economic system, and the direction in which it is headed.
Havel’s Art of the Impossible: A Critique Matt Sherwin
Matt Sherwin
I provide an overview of Vaclav Havel’s political foundation in moral principles, and examine whether his approach is applicable to decision-makers in office as well as those in the opposition.
Havel’s Art of the Impossible: A Critique Matt Sherwin
Matt Sherwin
I provide an overview of Vaclav Havel’s 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 Nazareth’s 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? Coercive Speech vs. 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 pornography’s 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. On the 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 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, I worked with the Environmental Advisory Council as well as with the Transition Town group in Media, Pennsylvania to estimate Media’s 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 Court’s Consideration Of Foreign And International Law
Richard Tao
This Article produces new historical evidence in relation to the ongoing debate surrounding the Supreme Court’s 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 judiciary’s 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 Court’s invocation of foreign and international law—a surprising fact given the era’s intimate relation to the legal measures most often at issue in cases involving nondomestic citation. 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 period’s 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 $2.6 trillion each year on health care – $8,402 per capita and nearly 18% of GDP[1].  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 capita[2].             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 care[3].  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 18.4% of its health care budget on prescription drugs in 2003[4].  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 Zealand[5].  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 and generic manufacturers.  Innovator (or pioneer) firms invest millions of dollars in pharmaceutical research and development to engineer entirely novel drugs[6].  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), 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 FDA’s 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 R&D.  In a single stroke, it facilitated entry of generic drugs by creating a streamlined the approval process and essentially allowed for the formation of today’s 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.  In the decades since the passage of the Hatch-Waxman Act, there have been “quantum leaps in scientific research”[7].  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 2005 and 2010, 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.  For this reason, “generic” versions of biologics are more accurately described as “follow-on biologics” or “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 unrealistic[8].  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 $1.2 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 Act’s 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 Drug Administration of safe and affordable generic versions of biologic medicines”[9].             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.  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 R&D without extended patent exclusivity, market protection should remain the same as with traditional pharma or even shortened.  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.  I will then propose a set of policy revisions to facilitate the growth of the follow-on biologics market.  I hope to find the right balance between innovation, access, and safety.  From an ethical perspective, which one is most important for society?  How will the BPCIA shift the equilibrium established by three decades under Hatch-Waxman, and what does this shift say about American perspectives on health care?  By analyzing the dialogue surrounding abbreviated biosimilars approval and reviewing the impact of the Hatch-Waxman Act, I hope to gain an understanding of the ethical, political, and economic implications of the BPCIA. The various portions of this essay will explain and analyze the Hatch-Waxman Act and BPCIA, then apply the lessons of the landmark 1984 law to its recent successor.  It will begin by briefly reviewing the history of the Hatch-Waxman Act and explaining the specific provisions of the law.  This essay will then move on to the BPCIA: it will begin with a more in-depth overview of the biologics industry, then compare and contrast follow-on biologics with small-molecule generic drugs.  Using this background information, I will help the reader understand the history and politics behind the act, as well as its specific provisions.  In the Discussion section, I will investigate the impact of the Hatch-Waxman Act on pioneer drug manufacturers, generic manufacturers, and consumer.  I will then project the impact of the BPCIA on the industry and market for innovator biotech firms, follow-on biologics, and the American public.  Using this information, I will compare and contrast the outcome of the Hatch-Waxman Act with the projected impact of the BPCIA to draw attention to particular issues that will arise when the BPCIA is implemented. Finally, I will apply the lessons learned from the Hatch-Waxman Act to the BPCIA.  Specifically, I will find that the abbreviated biosimilar approval pathway created by the BPCIA does not lower barriers to entry for biosimilars to nearly the same extent that the ANDA process did for generics.  Due to continued high entry costs and an excessively long period of data exclusivity, it is likely that the hoped-for biosimilars market will be underwhelming in size and impact. Instead, would-be biosimilar firms may create “biobetters” that circumvent biologic patents and are approved through the non-abbreviated process.  Ultimately, cost savings to consumers will not be nearly as high as those produced by the Hatch-Waxman Act. I will conclude with a discussion of the ethical, political, and economic impact of making specific adjustments to the BPCIA.  Should we prioritize innovation, access, or in the case of biologics, safety?  While research-based pharmaceutical firms and many economists stress “the importance of patent protection in insuring the viability of future innovation… consumers want continued access to prescription drugs – at affordable prices”[10].  This delicate balance is further complicated by the politics of health care costs, budget reductions, intellectual property, and support for business versus protection for consumers.  Economically, this essay will assess the impact that a biosimilars market will have on micro-level decision making by biologic and biosimilar firms, and on macro-level health care spending and its implications for the United States. [1] Centers for Medicare and Medicaid Services.  Data for 2010. [2] “OECD Health Data.”  Data for 2009. [3] IMS Institute for Health Informatics [4] “Drug spending in OECD.”  Japan spends just 8% of its GDP on health care. [5] Squires 11 [6] Or at least somewhat novel.  Innovator firms also often create “me-too” drugs that make incremental improvements on already-existing drugs. [7] Strongin 2 [8] Bioequivalence allows the FDA to assume that because one small-molecule drug is molecularly identical to another, it will test similarly for safety and efficacy.  This concept will be explained more later on. [9] “Honoring the 25th” 3 [10] Strongin 2
Rights of Residency Ramon Gonzalez
Ramon Gonzalez
Introduction: We live in a world of strangers, some of whom we call fellow citizens. Many other strangers (and friends) we do not, and they may live as citizens in other countries or as non-citizens in our own.[1] I am interested in the relationship between citizens and the non-citizens residents who live with them: in what ways are non-citizen residents part of the political communities in which they live, and insofar as non-citizen residents are members of those communities, what rights do they have in them? My answer is that non-citizen residents are members of the local political communities in which they live, and they are entitled to the local rights (political, legal, economic, social) that are derived from and characteristic of membership in the local community. There are many non-citizen residents, or migrants, or resident aliens, or immigrants, or however else we label people living in countries where they are not citizens.[2] The increase in non-citizen residents has many effects and poses many challenges, but the one I consider is this: how must existing members of the political community regard non-citizen residents? It is a question, unfortunately, that a lot of political and philosophical thinking leaves us ill-equipped to answer. Most accounts of the political community, its organization and the demands and rights of membership in it, have remained largely silent on the status and treatment of newcomers, and this is true all the way from Plato’s Republic to Rawl’s A Theory of Justice[3]. More recently, as the number and volume of the appeals of immigrants or potential immigrants to enter national communities has increased, there has been greater scrutiny of limitations placed on immigration, with some (Carens 1987) going so far as to argue for open (or nearly open) borders.  Within the nation, the presence of many non-citizens has spurred reflection about what national citizenship means and entails, and what should be the process for acquiring it (see the essays in Pickus et al. 1998). While most of the academic literature has focused on the points of physical entrance into a community and entrance into membership, some have tried to bridge that gap, and Michael Walzer argues in Spheres of Justice that guest workers and immigrants in a community must also be “set on the road to citizenship” (Walzer 1984:60). Walzer’s work has spurred a lot of debate, but his reasoning remains controversial, and the increase in non-citizen residents who do not become citizens[4] has made it less convincing to rely on some imagined future status as a way of deriving the treatment and rights that non-citizen residents must have now. Lately, work has focused its attention on non-citizen residents as a unique category and offered a host of reasons why they should be treated better. Non-citizen residents exist too much as a caste that erodes the democratic character of the state, or non-citizen residents do not enjoy equality before the law (L. S. Bosniak 2007), or non-citizen residents need to enjoy a “parity of participation” with citizens (Fraser 2007). These are sympathetic and often compelling arguments and appeal to reservoirs of strong moral feelings of respect, recognition, and equality. However, I think these arguments ultimately fail because their focus on how we should treat non-citizen residents does not address the prior question of the status of non-citizen residents: equality or parity of participation, sure, but of what? and with whom?[5] Instead of asking what citizens might owe non-citizen residents, I want to first determine who non-citizen residents are and to what extent they are members of some of the political communities in which they live. Only if we first clarify the membership (and non-membership) status of non-citizen residents will it be possible to make more specific and demanding claims—for equality, parity of participation, non-domination, etc.—on their behalf. But to determine whether non-citizen residents are members of certain kinds of political communities, first we have to develop some agreement on what membership in those groups means. I build this from the bottom up, and this is a brief sketch[6] of the philosophical moves: First, I consider the justification and scope of a political community and the basis for membership in it. Next, I recognize the existence of many different kinds and scales of political community which overlap and intersect, and I discuss how we might balance and regulate people’s belonging to them. Then a newcomer arrives: different kinds of political communities include or do not include him, and I argue that the basis for the local community requires it to regard the non-citizen resident as a member of it. Because the non-citizen resident is a member of the local community, the non-citizen residents is entitled to the rights and privileges of local membership (I call these the ‘rights of residency’), and these can include voting rights for local elections, the ability to run for local office, the enjoyment of higher ‘living wages’, and accommodation of linguistic or religious differences. Local communities will have their differences here. No matter what local communities specify, extending the rights of residency to non-citizen residents will entail a substantial change in how citizens treat them and, perhaps more importantly, how citizens regard non-citizen residents and how non-citizen residents regard themselves. This essay takes the challenge of non-citizen residents’ presence not as a question about what citizens owe others but an opportunity to recognize non-citizen residents as members of communities with fellow citizens. Before I move on, I want to outline the different chapters and steps in the arguments that follow. In the next section (B), I detail the condition of non-citizen residents today and the various political, economic, and social changes that have spurred and changed migration patterns. While those changes have also led to the development of new types of political community and activity—international, transnational, global—I resist concentrating non-citizen residents’ political membership in these new forms. To avoid jumping headlong into these complicated new political arrangements and alternatives, I move back in Chapter 2 to give an account of what is the basis of political community: how can we characterize a political community, and why does it form? Rejecting theories of consent or ascription, I instead build on insights from discourse ethics to put forward a principle of engagement that recognizes political communities by systematic interdependence, communicative patterns, and the possibility for institutions to mediate these relationships. Accompanying the principle of engagement is the principle of proximity which explains why the presence of these seemingly descriptive characteristics—interdependence, communication—generates the normative force and requirement to form a political community. The principle of engagement lays out what local political community means, and the principle of proximity defends why those criteria matter. Chapter 3 expands to acknowledge and include many different kinds and scales of political communities that overlap and intersect. To regulate the boundaries between the different political communities, I introduce the principle of inter-group freedom. Chapter 3 ends by acknowledging that the principle of proximity may not apply to all different types of political community, but that it has particular purchase on local political communities. Chapter 4 then asks how newcomers fit into the account of political community (and communities) the previous two chapters developed. Rejecting some alternatives, I re-focus the challenge posed by non-citizen residents around the fact that they are here. Chapter 5 answers that non-citizen residents are members of the local political community. First, it follows Chapter 3 in limiting the scope, at least for this essay, of the principle of proximity, and uses it to explain the normative requirement to form local political communities. Next, the second section of the chapter details how local residents, citizen and non-citizen, meet the principle of engagement’s criteria for a political community: systematic interdependence, communicative patterns, and institutional capacity. Chapter 5 closes in its third section by detailing what rights and privileges membership in the local community can consist of, and I call these the ‘rights of residency’.             Chapter 6 engages several challenges to the rights of residency: the distinction between local and larger political communities is not as stable as I presume, rights of residency might result in harsher treatment of immigrants (and especially future immigrants), and rights of residency might undermine local political life. Chapter 7 responds with some other hopes for rights of residency, namely that it might integrate non-citizen residents into the community’s political life and prepare them for perhaps joining the national political community. Chapter 8 concludes the essay and notes future directions for research. [1] We even may be those non-citizens. [2] I will continue to use the language of non-citizen residents, which I take to mean individuals who live in countries in which they are not citizens. This still invites questions—how long do you have to be in a country before you “live” or “reside” in it?—and I will later offer some guidance on how to begin answering them, but the exact parameters of what it means to be a non-citizen resident will have to be worked out in communities through discussion and decisions.  [3] “I shall be satisfied if it is possible to formulate a reasonable conception of justice for the basic structure of society conceived…as a closed system isolated from other societies” (Rawls 1999:6). [4] For an overview of the complex forms and shapes of migration today, see (Benhabib and Resnik 2009). [5] I have the sense that whereas a lot of disputes in political theory and ethics are about what justice, rights, or morality demands, most real disagreement is not about those ends but to which subjects we owe them (or who even counts as a subject!). [6] I give a more formal outline of the essay at the end of the introduction.