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This paper examines communication strategies, organization, and tactics of the pharmaceutical firm Merck & Co., Inc., as corporate executives and staff faced the withdrawal from market of Vioxx, the company's most profitable product.

The paper explores decision methodology and criteria as Merck executives sought to communicate with their most important stakeholders during the most dangerous and critical period in the company's history.

As well prepared as Merck & Co. was for a product withdrawal, nothing could have prepared company officers for communicating on the scale, scope, and volume that this crisis would demand. The value of a well‐conceived crisis response plan is underscored, as well as a flexible, responsive organization. Among the more notable findings is that even large, well‐funded, experienced professionals may need to reconsider their organizational structure as they address a multi‐faceted, large‐scale problem. Issues include staffing, functional expertise, length of time on task, and strategic use of key resources.

A number of important lessons in communication strategy have emerged from the experience of withdrawing Vioxx from the market and defending the company against both litigation and continuing bad press. First, a crisis communication plan is essential. Their plan allowed Merck & Co. to identify key individuals to be involved, their roles and responsibilities. A second important lesson concerns persistence and a long‐term view, despite near‐term pressure for earnings performance. Overcoming plaintiffs‐bar litigation may take another five years. A third lesson involves identifying and measuring those issues which Merck stakeholders most needed to know in order to correct misconceptions. Finally, corporate officers recognized that they must have faith in their decisions and recognize the value of their employees (across the organization) in communicating the company's message.

This paper examines the pharmaceutical firm Merck & Co., Inc. and the withdrawal from market of Vioxx, the company's most profitable product.

Pharmaceutical companies are faced with identifying development compounds for their Drug Development Processes (DDPs) that will not only gain approval for sale by the regulatory agencies, such as the Food and Drug Administration (FDA), but also establish a sustainable and profitable market presence. This identification of compounds for the DDP includes projection of objective criteria, such as ability to generate revenue and profitability (Financial) and safety and efficacy (Clinical), as well as more subjective criteria, such as determination of insurance coverage by payers, such as the Centers for Medicare and Medicaid Services and pricing (Reimbursement), ability to produce a product of consistent quality (Manufacturing), and attain approval for sale in a timely manner (Registration). The Analytical Hierarchy Process (AHP) is a multi-criteria decision model that can integrate both objective and subjective information. This study applies the AHP methodology to the identification of compounds resulting in a dynamic application of the model that can be used by pharmaceutical companies to determine the best compounds to put in the DDP, at a time when the cost of conducting clinical evaluations for development compounds is very high and global market conditions are evolving.

The aim of this paper is to describe an innovative practice that has implication for new product developers within and outside the pharmaceutical industry.

The case describes an approach to managing the risk inherent in marketing drugs. The organization's original name has been retained, although individual managers' names have been changed at its request. Interviews with former company employees and publicly available data were used to write the case study.

The paper provides information and action approaches to new product developers that may reduce the risk of losing products to regulatory action. The subject company devised a risk management response to its product development. Their results offer direct implications for new product development teams in the drug industry. By extension, the implications may aid traditional companies outside of the pharmaceutical industry.

As in all case studies, the specific conditions found in one organization may not be found more generally in others. Readers are cautioned that the conclusions drawn in the case may have limited applicability.

The case depicts an innovative application of the risk minimization to the new product development process. Other organizations may find the technique of value in their own efforts.

The case is the first to describe a successful application of risk management to the product development/product management process. It offers the potential of improving the lifetime of pharmaceutical products in the marketplace, allowing the company a longer time to reap profits.

The purpose of this paper is to value the patents of pharmaceutical companies using discounted cash flows, and compare the value-relevance of these assets against alternative intangible asset measures such as reported intangible assets and R & D capital.

The study values pharmaceutical intangibles using three methods: an income method; the sum of unamortised R & D expenditures; the firm’s reported intangible assets. Value-relevance tests use ordinary least squares regression and Vuong and Clarke tests.

First, the study finds that the discounted cash-flow valuation of pharmaceutical patents is value-relevant. Second, the value of pharmaceutical patents explains market value better than reported intangible assets but not R & D capital. However, the valuation of pharmaceutical patents is more consistent with the risks of R & D than the valuation of R & D capital which assumes recovery of R & D expenditure.

This is the first known study that values patents using an income method and compares those valuations with reported intangible assets and R & D capital valuation models.

Attempts to describe some of the forces which, from a marketing perspective, drive and shape the pharmaceutical industry. The industry is of massive importance to the UK economy and rarely a day goes by without mention in the press of the activities of the leading manufacturers – Glaxo, Wellcome, SmithKline Beecham etc. British companies are amongst the most innovative in the world and pharmaceuticals is the only area of science where the UK can claim to match, and frequently outperform, the Americans, Japanese and Germans. Written by a layman for the benefit of laymen.

This study aims to access, analyze and highlight opportunities and problems of the Indian pharmaceutical sector in the broader national health-care industry. The recent changes in the field, at the institutional and corporate levels, have placed India in the spotlight of the global pharmaceutical market, but several threats and weaknesses could limit this expansion.

Descriptive and inferential analyses have been based on empirical data extracted from authenticated data sources. Subsequently, a narrative strengths, weaknesses, opportunities and threats analysis was performed based on the results of prior investigations and on qualitative data that were retrieved from a marketing intelligence examination to generate an overall scenario analysis.

Indian pharmaceutical companies have faced several challenges on various fronts. In the home market, drug prices are controlled by the drug price control order; therefore, there is strong pressure on revenues and subsequently on costs. In the international market, threats derived from pharmaceutical multinational companies are emerging as tough obstacles to overcome.

More focus on patents for innovative drugs is required, instead of concentrating primarily on generic drugs. There is a need for policymakers to work on the sustainability and development of the industry, while the companies must redesign their orientation toward enhancing innovation capabilities. In addition, at the level of corporate strategy, firms should establish collaborations and alliances and expand their industrial marketing vision.

This study provides a global overview of the potential growth and development of the Indian pharmaceutical sector, comparing it with internal trends and external competition. The most relevant contribution of the research relies on the shift to innovative production that Indian companies must adopt (after years of focusing only on generic drugs), and in this vein, appropriate industrial marketing solutions are indispensable.

The relationship between patents and the pharmaceutical industry is both complex and important. While many believe that patents are manipulated by the pharmaceutical industry for its own economic ends, a historical approach to the utilization of patents combined with an analysis of current patent issues places this relationship in its proper context. Though patents were created long before the pharmaceutical industry reached its current status as a major industry in the United States, a historical, analytic approach shows that the pharmaceutical industry has adjusted to constantly evolving legislation enacted to provide the most effective and efficient system by which to research, invent, regulate and patent new medicines.

To present the view that harm arising from aggressive marketing and sales of health-related products and services (including dangerous and defective ones) in order to maximize profits should be a cause of concern for public health academics and practitioners.

The discussion is conducted using biomedical ethics principles and supported using various real-world examples.

Harm arising from aggressive marketing and sales of health-related products and services (including dangerous and defective ones) in order to maximize profits should be a cause of concern for public health academics and practitioners. In the area of products, the most obvious would be tobacco products. In the case of pharmaceutical drugs, it would include overuse or inappropriate use because of aggressive marketing. It would also include harm caused by the continued promotion and sale of a drug in the face of evidence that it has significant negative side effects. Brody and Light’s “Inverse Benefit Law,” that is, the benefit-to-harm ratio of drugs tends to vary inversely with how aggressively drugs are marketed is discussed. Harm is also evident in health-related services, for example, misuse of ultrasonography for sex-selective abortion. This chapter will discuss how the risk of harm is increased because of questionable marketing strategies used by drug companies.

One limitation is that no attempt to quantify the harm done (e.g., through economic evaluation techniques) is carried out.

This chapter presents the view that much more attention should be paid to this aspect of medicalization as a public health threat.

We are in the midst of a broad societal change in which women’s sexual problems are becoming increasingly medicalized, characterized as treatable medical conditions and defined and understood as a largely physiologically based disease, called “female sexual dysfunction” (FSD). When a condition is medicalized, a medical framework is used to understand it, and medical interventions are used to treat it. As part of this process, then, over the last several years, researchers and pharmaceutical companies have turned attention to developing medical treatments for FSD. As this medicalization continues to unfold with potentially important impacts, it is crucial that we understand the forces working to shape it.

The Orphan Drug Act has provided the pharmaceutical industry with incentives to research and develop drugs for orphan diseases: rare diseases with little profit potential. It is considered very successful legislation by legal scholars, the Food and Drug Administration (FDA), and orphan drug activists. The policy process of the Act provides an important model of the policy process for future incentive-based pharmaceutical legislation. The purpose of this paper is to summarize the important incentives of the Act and the historical events leading up to the Act. The paper applies three different theoretical models of the public policy process to understand the emergence of the Orphan Drug Act: Kingdon’s Multiple Streams Model, the Advocacy Coalition Framework, and Social Constructionism Theory. The paper then synthesizes the public policy process lessons from each perspective and provides four recommendations for other social activists seeking to propel incentive-based pharmaceutical legislation for under-researched diseases.

The author analyzes the history of the Orphan Drug Act based on publicly available scholarly research, government documents, and interest group publications. The author then applies three public policy theories to the history of the Orphan Drug Act to explain the emergence of the Act and to extract policy process lessons for future disease activists.

Regardless of which theoretical perspective the Orphan Drug Act is analyzed from, some common themes of the policy process emerge. First, focussing events are instrumental in capturing the public’s sympathy and Congress’s attention. Second, in its activities and proposed legislation, a coalition should provide a role for all relevant and important actors. Third, the target groups of the legislation were construed positively, increasing the pressure for Congressmen to pass some kind of bill. Finally, the proper construction of “the problem” is instrumental to passing effective legislation as a “solution.”

The Orphan Drug Act is widely considered successful incentive-based pharmaceutical legislation. However, because it was originally passed in 1983 and has not had public attention since the early 1990s (when it was amended), it has rarely been written about in recent years. However, its lessons are still highly relevant to policy activists, especially disease activists. Furthermore, existing articles focus on the impact of the legislation and ways to amend it, rather than on the passage of the Act.