Repositioning Generics: The Comparative Value of Liability in FDA's Proposed Rule on Labeling

2015 ◽  
Vol 41 (2-3) ◽  
pp. 483-504
Author(s):  
Nicholas Falcone
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Free Market ◽  
Federal Law ◽  
Market Position ◽  
Generic Competition ◽  
Market Economic ◽  
Patent Term ◽  
Dominant Market Position ◽  
Prescription Drug Costs

Generic drugs occupy a unique position in the U.S. pharmaceuticals market. On one hand, generics are a product of basic free-market economic reasoning. Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) based on the uncontroversial assumption that inexpensive generic competition would reduce prescription drug costs. On the other hand, the generic drug industry is primarily a regulatory creation; Hatch-Waxman facilitates generic competition by permitting generic manufacturers to rely heavily on prior expenditures of pioneer drug manufacturers, including those required to convince the Food and Drug Administration (FDA) that a drug is safe and efficacious. Propelled by federal law, generics have evolved from their minority market position as cheap alternatives to a “dominant” market position—today, they fill about 80% of prescriptions nationwide.

scholarly journals Is greater generic competition also linked to lower drug prices in South Korea?

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Kyung-Bok Son
Keyword(s):  
South Korea ◽  
Regression Model ◽  
Multivariate Regression ◽  
Price Competition ◽  
Generic Drugs ◽  
Anatomical Therapeutic Chemical ◽  
Multivariate Regression Model ◽  
Generic Competition ◽  
Market Competitiveness ◽  
Maximum Price

Abstract Background Although the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and market competitiveness in South Korea. Methods A list of originator drugs approved by the national authority from 2000 to 2019 and their corresponding generic drugs were grouped along with the baseline information. The market was categorized into four groups based on the number of manufacturers: duopoly (2 manufacturers); low- (3–25 manufacturers); medium- (26–75 manufacturers); and high-competition (more than 76 manufacturers) markets. Price variance, calculated as the difference between the maximum price and minimum price divided by the maximum price, was obtained. A multivariate regression model was applied to regress price variance on the characteristics of market competitiveness, controlling for the characteristics of the originator drugs and their price level in the market. Results A total of 986 originator drugs were identified and then divided into duopoly (31%), low- (56%), medium- (9%), and high-competition (4%) markets; the median of the price variance for these markets was 0.013, 0.077, 0.200, and 0.228, respectively. In a multivariate regression model, price variance was associated with the characteristics of the originator drug, including the Anatomical Therapeutic Chemical classification, the route of administration, and the approval year. Controlling for the characteristics of the originator drugs, market competitiveness was positively associated with price variance. Conclusions The positive association between price variance and market competitiveness is still consistent in South Korea, where rare price competition among a large number of generic manufacturers has been reported. However, no significant price variance was observed between medium- and high-competition markets. These findings support policies for managing a large number of generic manufacturers in South Korea.

Unma(s)king Education in the Image of Business: A Vivisection of Educational Consumerism

2017 ◽  
Vol 17 (4) ◽  
pp. 333-346 ◽  
Author(s):  
Roy Schwartzman
Keyword(s):  
Higher Education ◽  
Free Market ◽  
Promotion And Tenure ◽  
Improve Efficiency ◽  
Market Economic ◽  
University Life ◽  
Critical Autoethnography ◽  
Personal Perspectives ◽  
Tenure Process

Configuring students as consumers and higher education as a commodity have been widely suggested as ways to empower students and improve efficiency. This critical autoethnography challenges the assumptions and implications of modeling education after free market economic principles. Personal perspectives on the promotion and tenure process, students confronting the marketplace, and exemplary mentoring accompany poetic reflections on market-infused university life.

scholarly journals The Objectives of Competitive Intelligence as a Part of Corporative Development Strategy

2014 ◽  
Vol 62 (6) ◽  
pp. 1243-1250 ◽  
Author(s):  
František Bartes
Keyword(s):  
Development Strategy ◽  
Competitive Intelligence ◽  
Corporate Management ◽  
Market Position ◽  
Top Managers ◽  
The Development Strategy ◽  
Intelligence Operations ◽  
Future Situation ◽  
Dominant Market Position

This paper deals with the issue of the management cycle of Competitive Intelligence. The author describes the process of Competitive Intelligence in Czech corporate management. He concludes that in most cases, the Competitive Intelligence operations are directed by the top management, and the attention of Competitive Intelligence is being paid to Key Intelligence Topics (KIT). The Competitive Intelligence is then focused on the output of strategic analyses, complemented in some cases with a summary (synthesis) of acquired intelligence plus some signal intelligence (SIGINT). The results of the Competitive Intelligence produced in such a way are actually the outputs mostly applicable in operational management and mostly unsuitable for strategic management. However, top managers abroad almost invariably need the data relevant to the future situation since their decisions are of strategic nature. The following section of the paper is devoted to the conceptual solution of Competitive Intelligence, i.e. the Competitive Intelligence objectives linked with the development strategy of the corporation. Here the author arrives at three basic development strategies: a.) the corporation desires status quo, i.e. to keep its market position as it is, b.) the corporation is out to expand, and c.) the corporation intends not only to keep its existing and dominant market position but strives for its long-term dominance to last.

scholarly journals Friedrich A. von Hayek e il problema della solidarietà

2021 ◽  
pp. 95-118
Author(s):  
Dario Antiseri
Keyword(s):  
Social Justice ◽  
Economic System ◽  
Free Market ◽  
Trojan Horse ◽  
Political Freedom ◽  
Great Society ◽  
Market Economic ◽  
The Social

In the development of science and of a democracy, competition represents the highest form of collaboration. The same applies in the free market economic system that supports political freedom and corresponds to the most secure source of extended welfare. However, Hayek warns that The «Great Society» is seriously threatened by the comeback of the social-ism’s «tribal ethic»: «the concept of ‘social justice’ has been the Trojan horse for the entrance of the totalitarism». By saying this, he does not deny the value of solidarity. The Great Society can allow itself to help those in need, and actually it must do it. Resumen. La competizione nello sviluppo della scienza e nella vita di una democrazia costituisce la piü alta forma di collaborazione, cosí come lo é nell’economia di mercato - sistema económico che sta a base delle liberta politiche e che é la fonte maggiormente sicura del piü esteso benessere. La Grande Societá, tuttavia, é seriamente minacciata - ammonisce Hayek - dalla riaffermazione dell»’etica tribale» del socialismo: «il concertó di ‘giustizia sociale’ é stato il cavallo di Troia tramite il quale ha fatto il suo ingresso il totalitarismo». Con ció Hayek non nega affatto il valore della solidarietá, in quanto la Grande Societá puó permettersi di aiutare i piü deboli e deve farlo.

Neil Kinnock’s perestroika: Labour and the Soviet influence

2018 ◽  
Author(s):  
Jonathan Davis
Keyword(s):  
Soviet Union ◽  
Political Thought ◽  
Free Market ◽  
New Right ◽  
Mikhail Gorbachev ◽  
The Soviet Union ◽  
Market Economic ◽  
Socialist Movement ◽  
The Relationship ◽  
Do So

The Labour Party’s socialism changed dramatically in the 1980s. Neil Kinnock’s restructuring of Labour occurred at the same time as the international socialist movement moved away from the statist model of economics and turned, in varying degrees, to more market-orientated ideas. This chapter assesses the ways in which Labour’s political thought adapted both to New Right realities and to the fact that much of world was adopting free market economic ideas. The particular focus here is the development of Kinnock’s ideas in light of the changes in Soviet socialism after Mikhail Gorbachev introduced his reform programme. The Soviet Union had long influenced Labour’s ideology in both positive and negative ways, and this chapter shows how it continued to do so in 1980s. It examines the relationship between Kinnock’s Labour and Gorbachev’s USSR, and it shows how the changes introduced by both leaders began to lead to a convergence of ideas between Eastern and Western European versions of socialism.

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

State Developmentalism Without a Developmental State: The Public Foundations of the “Free Market Miracle” in Chile

2001 ◽  
Vol 43 (2) ◽  
pp. 1-25
Author(s):  
Marcus Kurtz
Keyword(s):  
Development Strategy ◽  
Free Market ◽  
High Growth ◽  
Developmental State ◽  
Insurance Markets ◽  
Economic Policies ◽  
Public Intervention ◽  
The Public ◽  
Market Economic ◽  
International Comparative

AbstractIf export orientation is a goal in a sustainable development strategy, this study argues that public interventions at the sectoral level in a variety of markets can produce economic reorientation that pursues international comparative advantage faster and at lower cost than free market forces can. Pervasive failures in information, credit, input, distribution, and insurance markets can render strictly market-based adjustment both slow and costly. Although Chile's export boom and high growth rates have been associated with its free market economic policies, this article, based on a comparison of the fruit, fish, and forestry sectors, contends that new forms of public intervention were crucial catalysts in shaping a sustained export response.

The uncritical critique of ‘liberal peace’

2010 ◽  
Vol 36 (S1) ◽  
pp. 137-155 ◽  
Author(s):  
DAVID CHANDLER
Keyword(s):  
Cold War ◽  
Free Market ◽  
Post Cold War ◽  
Post Conflict ◽  
Market Economic ◽  
Liberal Peace ◽  
Conflict Intervention ◽  
Winner Takes All ◽  
International Statebuilding ◽  
Policy Elites

AbstractFor many commentators the lack of success in international statebuilding efforts has been explained through the critical discourse of ‘liberal peace’, where it is assumed that ‘liberal’ Western interests and assumptions have influenced policymaking leading to counterproductive results. At the core of the critique is the assumption that the liberal peace approach has sought to reproduce and impose Western models: the reconstruction of ‘Westphalian’ frameworks of state sovereignty; the liberal framework of individual rights and winner-takes-all elections; and neo-liberal free market economic programmes. This article challenges this view of Western policymaking and suggests that post-Cold War post-conflict intervention and statebuilding can be better understood as a critique of classical liberal assumptions about the autonomous subject – framed in terms of sovereignty, law, democracy and the market. The conflating of discursive forms with their former liberal content creates the danger that critiques of liberal peace can rewrite post-Cold War intervention in ways that exaggerate the liberal nature of the policy frameworks and act as apologia, excusing policy failure on the basis of the self-flattering view of Western policy elites: that non-Western subjects were not ready for ‘Western’ freedoms.

Sign in / Sign up

Export Citation Format

Share Document