Browsing by Subject "Pharmaceutical Industry"
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Item Open Access Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act(1992-10) Grabowski, Henry G; Vernon, John MIN 1984, Congress enacted a new law that greatly affected the economics of the pharmaceutical industry in the United States. It has been characterized as the most important legislation affecting competition in the pharmaceutical industry since the 1962 Kefauver-Harris Amendments to the Food and Drug Act. This 1984 law, known as the Drug Price Competition and Patent Term Restoration Act (hereinafter the 1984 Act), facilitated the entry of generic drug products after patent expiration while it also restored part of the patent life lost during the premarket regulatory process for new introductions.1 Market entry by generics was relatively limited prior to 1984 because of costly Food and Drug Administration (FDA) requirements that had to be met by the imitative products. That is, generic drugs often would have to duplicate many of the pioneer's tests to gain market approval after patent expiration. As a result of the 1984 law, generic products need only demonstrate bioequivalence to the pioneer's brand, and generic entry has increased significantly. This has provided a body of very interesting data to analyze the pattern of entry and the pricing strategies followed by the entrants and incumbents. In this article, we make use of data covering the sales and prices of the pioneer and generic products for eighteen drug products, generally over the time period 1984-88.Item Open Access Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry(1978) Grabowski, HG; Vernon, JM; Thomas, LGINNOVATION in the U.S. ethical drug industry in recent years has been characterized by a number of adverse developments. In particular, there has been a sharp decline in the rate of new product introductions and the incentive for engaging in research and development (R & D) activity has been negatively influenced by rapid increases in the costs and risks of developing new products. While there is little debate about the existence of these adverse trends, there is considerable controversy about the factors producing them. Briefly, we list below five hypotheses that have been discussed as explanations for the declining rate of innovation.`Item Open Access Medicalization as a Rising Rational Myth: Population Health Implications, Reproduction, and Public Response(2011) Zheng, HuiIn this dissertation, I study medicalization, a wide spread phenomenon in this world but understudied in the current literature. The main theoretical focus of this dissertation is on expanding the medicalization theories. Questioning the breadth of conceptualization, the feasibility of measurement, and the depth of empirical implications in the extant medicalization theories, this dissertation proposes a new conceptual model of medicalization and further develops a quantitative measure of medicalization by disaggregating it into empirically valid dimensions that could be used to examine how degree of medicalization is related to social outcomes. Specifically, I conceptualize medicalization as an institutionalization process whereby the medical model becomes increasingly dominant in the explanation of health, illness, and other human problems and behavior. Medicalization is multidimensional and is represented by expansions in the three major components of the health care system: increasing medical investment, medical professionalization/specialization, and the relative size of the pharmaceutical industry.
Based on this new conceptual model and measurement, I probe three research questions: (1) how medicalization may impact population health in the context of recent epidemiologic transitions and how this impact may differ by the stages of epidemiologic transition and socioeconomic development; (2) what are the mechanisms that reproduce medicalization; and (3) how the lay public may respond to medicalization, the institution of medicine, and the medical profession.
This dissertation links several lines of theoretical and empirical research from medical sociology, demography, epidemiology, health economics and management, and medical science, and extensively employs OECD Health Data, World Development Indicators, the World Values Survey, the European Values Study data, the U.S. General Social Survey, and the U.S. National Health Interview Survey. It uses several advanced statistical methods, e.g., multiple imputations, latent variable analysis, mixed models, generalized estimating equations models, generalized method of moments models, difference-in-difference models, and hierarchical-age-period-cohort models.
Results for the first research question suggest that various dimensions of medicalization vary in importance on population health and these effects also differ by the stages of epidemiologic transition and socioeconomic development. I discuss the mechanisms linking various dimensions of medicalization to population health and then discuss these findings in the context of epidemiologic transition, fundamental causes of disease and death, and global health movement.
Results for the second research question suggest that medicalization at both the societal and individual levels negatively affect individual subjective health, which leads to increasing health care utilization. These social processes function together to promote and reproduce medicalization at societal level. I discuss several pathways linking medicalization to lower subjective health and other agents of medicalization.
Results for the third research question suggest that American's "confidence in the medical institution and profession" has continuously declined in the last three decades and groups with higher socioeconomic status report lower obedience to doctors' authority, but are more likely to trust doctors' ethics than their counterparts. I discuss the mechanisms for the changes in public confidence in the medical institution and profession, the status of medicine and the medical profession in the era of medicalization, the paradox of opposite trends in attitudes toward medicine and health utilization behavior, and group differences in obedience and trust.
Item Open Access Substitution laws and innovation in the pharmaceutical industry.(1979) GRABOWSKI, HG; VERNON, JMThe pharmaceutical industry has been among the most innovative while being one of the most highly regulated industries in the United States. Government regulation of pharmaceutical product quality started in 19061 and has evolved into a stringent system of premarket controls over new drug development and introduction. Several recent studies have examined the effects of these regulatory controls on the costs and development periods for new drug entities, the quantity of drug innovation, and delays in new drug therapies available to consumers.2 Government laws and regulations indirectly affect the innovation process through the distribution and marketing of pharmaceuticals. In contrast to other products, drugs can be dispensed to an individual only with a physician's prescription. This is true unless the Food and Drug Administration (FDA) has approved the drug for self-medication (i.e., over-the-counter us-age). Historically, state antisubstitution laws for prescription drugs have prohibited pharmacists from dispensing a different brand of a drug than the one prescribed by the physicians. A major structural change taking place in the pharmaceutical industry to-day is the repeal of state antisubstitution laws. Over forty states have passed product selection or drug substitution laws.3 While the state-enacted laws have significant differences, essentially all enable pharmacists to substitute generic products (some mandate substitution) unless a physician prevents substitution by checking a preprinted box or writing "dispense as written" (DAW) on the prescription form.