Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in this industry. This Article shows that the regulatory framework is not solely a burden imposed on the industry; it also provides a valuable service to the industry. Specifically, drug regulation provides certification of drug quality. Such certification, which may not be easily achieved by private market-based mechanisms, prevents the market from becoming a market for lemons. Therefore, rather than decreasing the expected returns to innovation, this aspect of regulation contributes to the value of new drugs and may actually encourage innovation. This point has largely been absent from most cost-benefit analyses of drug regulation, yet without it any discussion of the merits of regulation is incomplete

Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in this industry. This Article shows that the regulatory framework is not solely a burden imposed on the industry; it also provides a valuable service to the industry. Specifically, drug regulation provides certification of drug quality. Such certification, which may not be easily achieved by private market-based mechanisms, prevents the market from becoming a market for lemons. Therefore, rather than decreasing the expected returns to innovation, this aspect of regulation contributes to the value of new drugs and may actually encourage innovation. This point has largely been absent from most cost-benefit analyses of drug regulation, yet without it any discussion of the merits of regulation is incomplete

The First Sale Doctrine and the Economics of Post-Sale Restraints

The first sale doctrine limits the exclusive rights that survive the initial authorized sale of an item protected by intellectual property (IP) rights, and therefore limits the ability of IP owners to impose post-sale restraints on the distribution or use of items embodying their IP. While the doctrine has deep common law and statutory roots, its exact rationale and scope have never been fully explored and articulated. As a result, the law remains somewhat unsettled, in particular with respect to the ability of IP owners to opt-out of the doctrine and with respect to the applicability of the doctrine to situations of parallel importation. This Article provides answers to these unsettled issues. By applying insights from the economics of post-sale restraints, the Article shows that the main benefits of post-sale restraints involve situations of imperfect vertical integration between coproducing or collaborating firms, which occur during the production and distribution phases or shortly thereafter. In such situations, opting out of the first sale doctrine should be permitted. Beyond such limited circumstances, however, the first sale doctrine promotes important social and economic goals: it promotes efficient long-term use and preservation of goods embodying IP and facilitates user-innovation. Therefore, contrary to some other views, I conclude that the economics of post-sale restraints confirm the validity and support the continued vitality of the first sale doctrine

Masculinities and Femininities: Romance and Authenticity on American Dating Apps

The phenomenon of dating apps like Tinder, Bumble, and Grindr display the way image-based technologies allow for a new visual literacy. This study investigates how the experience of using dating applications (apps) related to Giddens’s notion of romance and explored the way visual literacy was constructed through discourses of authenticity. How do young Americans construct their social worlds through everyday actions and interactions on dating apps? How is romance re-conceptualized through dating apps, and what are the consequences of dating apps on gender identity and courtship? A qualitative, mixed methods approach was used to gather data. An online survey was distributed and semi-structured interviews were conducted. Results were triangulated to gain insight on notions of romance, gender identity, and visual literacy based on discussions of image codes and dating app use. The sample was Americans and people living America between ages 20-29 who used dating apps. The research demonstrates that the journalistic media’s discourses perpetuate stigmas of dating apps as virtual spaces for hooking up, when in fact they are used in complex ways that sustain notions of romance and solidify feelings of identity. Additionally, it establishes that authenticity is a primary factor in selecting profile images and communicating on dating apps

Copyright, Exhaustion, and the Role of Libraries in the Ecosystem of Knowledge

In this Article, written for a symposium on the future of libraries in the digital age, I present and challenge two common views about the scope of the first-sale doctrine, or exhaustion: namely, that the doctrine applies only to the transfer of tangible copies of works but not to the transfer of digital files, and that copyright owners can circumvent exhaustion by characterizing transactions as “licenses” rather than “sales”, or by contracting out of it. The law on digital exhaustion is anything but settled. As codified, the “first sale” doctrine it may limit only the distribution right, but its statutory presence might merely affirm a broader principle of exhaustion—one of the several principles in copyright law that limit the copyright owner’s powers. The principle of exhaustion can apply, and at times has been applied, beyond the distribution right. Likewise, the notion that copyright owners can circumvention exhaustion by characterizing transactions as “licenses” rather than “sales”, or by using contracts to exercise downstream control is hardly a foregone conclusion. Established precedent and sound legal principle indicate that while the law recognizes some scope for contracting around exhaustion, courts will not necessarily uphold any private reordering of the respective legal entitlements of copyright owners and users. While these observations and conclusions apply to exhaustion generally, they apply most demonstrably in the case of libraries. Libraries occupy a privileged space in the copyright system. Historically, libraries predate copyright, and the institutional role of libraries and institutions of higher learning in the “promotion of science” and the “encouragement of learning” was acknowledged before legislators decided to grant authors exclusive rights in their writings. The historical precedence of libraries and the legal recognition of their public function cannot determine every contemporary copyright question, but this historical fact is not devoid of legal consequence. History is part of the legislative history of statutes, and it constitutes part of the context that informs the interpretation of current statutes. Therefore, if not false, then the view that the current legislation does not allow digital exhaustion is at least questionable.This work was supported by the Social Sciences and Humanities Research Council of Canada (SSHRC

Margaret Thatcher, Golda Meir, and Indira Gandhi\u27s Actions and Rhetoric Regarding Feminism and Gender During Their Ascent to Power

This paper explores the rhetoric and actions of Margaret Thatcher, Golda Meir, and Indira Gandhi regarding feminism and their gender before they became prime minister. The paper finds that none of the leaders identified as feminists, and did not actively focus on women’s issues or elevate the status of women while in office. Yet, all of these leaders called for women to mobilize and pursue careers, either via their actions or speeches. Thatcher, particularly in the crucial period in which she rose to power, explicitly encouraged women to mobilize as voters and pursue work outside the home in her formal speeches, public statements, letters and interviews. Through their organized activities before they obtained office, Meir and Gandhi worked to mobilize women politically, although their rhetoric did not explicitly encourage women over men to participate politically. The paper explores nuanced ways that each leader associated with her gender and preached for other women to pursue careers. Looking ahead at one case study shows that women now are not necessarily averse to explicitly associating with their gender. Tzipi Livni, the candidate for the Kadima Party in the 2009 Israeli election, used her gender as a campaign tactic. Hopefully this paper helps lay the groundwork for future study on women candidate’s rhetoric and actions regarding feminism before they are elected

Advisement and Collaboration

Describes a collaboration between two Bank Street College advisees who had different strengths and levels of experience within the classroom

The Interaction of Exhaustion and the General Law

In Statutory Domain and the Commercial Law of Intellectual Property, John Duffy and Richard Hynes argue that IP exhaustion — the doctrine that limits a patentee’s or copyright holder’s control over goods in the stream of commerce — was created and functions exclusively to confine IP law within its own domain and prevent it from displacing other laws. In this essay, we explain why we are not persuaded. A central theme in Duffy and Haynes work is the argument that the common law did not play a role in the emergence and development of exhaustion. However, we show that the evidence they offer is inconclusive, incomplete, and at times inaccurate. Close examination of early exhaustion cases paints a more complex picture that cannot be squared with the idea that exhaustion was created independently of common law principles. Next, we explain how the approach Duffy and Hynes advocate would strip exhaustion of any normative content. While we agree that exhaustion draws a line between the domain of IP law and other laws and thus prevents the former from displacing the latter, the placement of that line is far from arbitrary, and has always reflected policy considerations. Finally, we note that Duffy and Hynes’ theory oversimplifies the relationship between IP law and state law, partly because it does not fully consider federal preemption