ItemGeneric Manufacturers’ Labeling Catch-22(2011) Lee, StaceyIn Wyeth v. Levine, the Supreme Court eliminated brand-name manufacturers’ ability to use the preemption defense against state law failure to warn claims involving allegedly misbranded pharmaceutical drugs. Since that time, a heated debate has ensued among federal courts and legal scholars regarding that holding’s effect on generic manufacturers. Lost amid these judicial opinions and scholarly articles, however, is a more fundamental inquiry. Regardless of whether preemption is a viable defense, what type of legal and regulatory framework is needed to ensure generic manufacturers possess the necessary tools to fulfill their responsibility of providing consumers and the medical community with current and accurate labeling instructions for their products? This Article proposes such a framework. ItemIs A CURE ON the WAY? – THE BAD MEDICINE OF GENERICS, CITIZEN PETITIONS, AND NOERR-PENNINGTON IMMUNITY(2010-03) Lee, StaceyOver the next five years, approximately 110 drugs, including blockbuster products such as Sanofi-Aventis’ allergy medicine Flomax, GlaxoSmithKline’s herpes medication Valtrex, and Pfizer’s cholesterol medication Lipitor will lose their patent protection. In 2009 alone, brand-name drugs coming off patent were valued at more than 10.8 billion dollars. As market exclusivity for these drugs ends, the doors for generic production will open. Generic drugs generally enter the market priced 20 to 80 percent lower than their branded counterparts, and generics can capture 44 to 80 percent of brand-name drug sales within a year after release. This price competition from generic drugs threatens the profits of brand-name manufacturers and reduces their returns on innovative activity. As a result, some brand-name drug manufacturers have resorted to aggressive tactics to blunt the impact of competition. ItemTechnological Change at Work: The Impact of Employee Involvement on the Effectiveness of Health Information Technology(2010-01) Litwin, Adam SethREVISED VERSION OF https://jscholarship.library.jhu.edu/handle/1774.2/33502?show=full. This paper uses employee and patient survey data from a large, integrated healthcare provider to assess the moderating role that employee involvement (EI) plays in the effectiveness of a patient scheduling module that is part of an electronic health record (EHR) system. The author finds that while the module facilitated the appointment-making process, its effects were greater in those clinics that sought input from frontline workers and made use of worker peers trained as system “super-users.” This study presents the first empirical evidence of EI’s potential to enhance the effectiveness of health IT, findings that should inform policymakers and sectoral actors as they allocate substantial resources toward the healthcare industry’s transition from paper-based to electronic recordkeeping. More critically, this case of workplace technological change advances work and employment theory beyond the analysis of union policies toward technological change, instead explaining how employment relations structures and processes influence the effectiveness ofnew technologies—IT in particular. ItemA Comprehensive Examination of the Wealth Effects of Recent Stock Repurchase Announcements(2010-01-12T15:57:54Z) Gangopadhyay, Partha; Yook, KenIn this paper we examine the wealth effect of stock repurchase announcements using a sample of 11,862 repurchase programs announced during 1994-2007. The results of several recent industry surveys indicate that managerial motivations for repurchasing shares may have changed in recent years. To better understand the reasons for repurchasing shares we classify our sample in various ways - by year, by the method used for repurchasing shares, by the stated purpose of the program, by the method of financing, and by program size. We find that the median size of firms repurchasing shares has increased dramatically recently, and concomitantly, the announcement returns have declined. Signaling undervaluation of share prices appears to become less important than previously assumed. While smaller firms signal undervaluation using open market repurchases, tender offers are chosen to enhance shareholder values by other means. ItemFree Cash Flows and the Wealth Effects of Stock Repurchase Announcements(2010-01-12T15:52:24Z) Gangopadhyay, Partha; Yook, KenThe free cash flow hypothesis predicts that repurchasing firms with free cash flows will have larger announcement-period abnormal returns than repurchasers that do not have free cash flows. We test the free cash flow hypothesis by examining the announcement-period abnormal returns of repurchasing firms sorted by their available investment opportunities, as measured by the Tobin's q ratio and cash flows. Firms with low q (less than one) and high cash flows are identified as firms with free cash flows. We find that firms with free cash flows earn significantly higher abnormal returns than all other firms. Cross-sectional regression analyses provide robust empirical support for the free cash flow hypothesis even after controlling for other variables that can affect the announcement-period abnormal returns. ItemSize Matters: The Impact of Physician Practice Size on Productivity(Johns Hopkins University Carey Business School, 2010-01) Gans, David; Liu, Kai; Hough, DouglasAbstract Physician practices in the US are largely small-scale, independently-run enterprises, despite their potential critical role in creating a more integrated health care system. Using an approach that builds on – and extends – prior research, we estimate physician practice production functions for different types of practices (multispecialty, single-specialty, and six subspecialties within single-specialty practices). We find that these practices have distinct production functions, and that size has different implications for each. In particular, we find that the median size physician practice is well below the size suggested by the estimated production function and marginal products of physicians, for almost all practice types. These results have interesting implications for health policy. ItemEntrepreneurship and Microfinance A Review and Research Agenda(Carey Business School, The Johns Hopkins University, 2009-11) Phan, PhillipAbstract In this paper, I review fifty four research papers spanning a 10 year period between 1998 and 2008 on research questions related to microfinance and entrepreneurship. I highlight the main research questions, summarize the most common methodological approaches and key findings, and offer observations on gaps in the literature with suggestions for future research questions. ItemInformed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad(Carey Business School, Johns Hopkins University, 2009-11) Lee, Stacey B.The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, the United States government and courts, and the media have played a significant role in defining those obligations. This article examines the evolution of those obligations through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust these obligations become on their face, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement from an international tribunal or from one universally adopted code of ethics. Rather than continuing to pursue an untenable international approach, this article argues that a viable enforcement mechanism lies in application of the Alien Torts Statute (ATS). Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victim redress and enforcing sponsor accountability for informed consent misconduct. A vital component in ensuring the world population’s “right to health” includes substantive human rights protections. This article concludes that by building on the federal appellate court’s ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in the United States, a mechanism for enforcing not only substantive informed consent, but also human rights protections can be created. ItemImplicit distancing in Auction: When name letter branding backfires(Carey Business School, Johns Hopkins University, 2009-10) Kachersky, Luke; Sankar, Sen; Kim, Hyeong-MinConsumers subconsciously prefer brand names that resemble their own names - an effect called name letter branding. We extend it and propose that a reversal of name letter branding, wherein consumers will subconsciously avoid self-resembling seller names, is possible when the buyer anticipates self-concept damage from an association with the seller. We find evidence of such behavior, which we call implicit distancing, in three studies. We show name letter branding and implicit distancing in actual transactions and determine underlying causal mechanisms in two experiments. Our findings suggest that self-concept motives determine the prevalence of name letter branding or implicit distancing. ItemEmployee Involvement in the Deployment of Health Information Technology(Carey Business School, Johns Hopkins University, 2009-07) Litwin, Adam SethPLEASE SEE REVISED VERSION AT https://jscholarship.library.jhu.edu/handle/1774.2/33783: This paper uses employee and patient survey data from a large, integrated healthcare provider to assess the moderating role that employee involvement (EI) plays in the effectiveness of a patient scheduling module that is part of an electronic health record (EHR) system. The author finds that while the module facilitated the appointment-making process, its effects were greater in those clinics that sought input from frontline workers and made use of worker peers trained as system “super-users.” This study presents the first empirical evidence of EI’s potential to enhance the effectiveness of health IT, findings that should inform policymakers and sectoral actors as they allocate substantial resources toward the healthcare industry’s transition from paper-based to electronic recordkeeping. More critically, this case of workplace technological change advances work and employment theory beyond the analysis of union policies toward technological change, instead explaining how employment relations structures and processes influence the effectiveness ofnew technologies—IT in particular. ItemWhy Don't Docs Digitize? The Adoption of Health Information Technology in Primary Care Medicine(Carey Business School, Johns Hopkins University, 2009-05-11) Litwin, Adam SethReformers in the US have earmarked substantial resources towards encouraging the adoption of electronic health records (EHRs). However, studies have yet to explain why physicians resist adoption and why the investments resulting from a policy push may prove ineffective for improving the efficiency of healthcare delivery. I theorize that health information technology (IT) facilitates certain outcomes that bolster industry-level efficiency, but that the conventional, “fee-for-service” financing of primary care prevents many physicians from appropriating these benefits. Those physicians financing care delivery from a prepaid premium, on the other hand, are positioned to internalize what are otherwise external economies attendant to health IT investment. I find strong statistical support for this theory in a unique panel of US-practicing primary care physicians that allows us to examine health IT adoption as far back as 2001 - long before it garnered policymakers’ attention. The results imply that reformers should focus not on encouraging health IT adoption per se, but on reforms that enable physicians to internalize what are presently socialized benefits.