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Article
Publication date: 26 August 2014

Mary E. Schramm, Jennifer L. Herbst and Angela Mattie

The purpose of the study is to review The False Claims Act (FCA) settlements and challenges facing the industry to suggest the motivation behind firms’ alleged fraudulent…

Abstract

Purpose

The purpose of the study is to review The False Claims Act (FCA) settlements and challenges facing the industry to suggest the motivation behind firms’ alleged fraudulent activity. FCA has been applied against pharmaceutical companies by the US Government to combat marketing fraud including kickbacks, improper pricing and off-label promotion. The interests of the US Government and medical professionals are also considered. Changes to the law governing pharmaceutical marketing practices are recommended.

Design/methodology/approach

Cases settled under the FCA between 2005 and 2012 were identified by accessing the US Department of Health and Human Services (DHHS) Corporate Integrity Agreements Web site and annual reports and the quitamhelp.com Web site. Case details were collected from US Department of Justice press releases, DHHS annual reports, and case documents in the Public Access to Court Electronic Records database.

Findings

Of the settled cases in the final sample, improper pricing practices were evident in 33 per cent of the cases; off-label promotion in 52 per cent; and both in 15 per cent of the cases. Forty-eight per cent of the alleged fraudulent marketing activity occurred within the brands’ first year and 68 per cent within the first two years on the market. Reported settlements ranged from US$4 million to US$4.3 billion.

Originality/value

This research simultaneously considers business issues facing the pharmaceutical industry and alleged fraudulent marketing activity to recommend changes to the law governing drug promotion. Changes have the potential to improve the balance between the respective interests of industry, medicine and government and to improve compliance and patient care in the future.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 8 no. 3
Type: Research Article
ISSN: 1750-6123

Keywords

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Case study
Publication date: 20 January 2017

Daniel Diermeier, Jason Hermitage, Shail Thaker and Justin Heinze

In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting…

Abstract

In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in the treatment of certain types of cancer and cases of HIV/AIDS, the Celgene corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug's approval.

To illustrate how regulators are subject to political pressure, which companies much recognize and consider when making business decisions.

Details

Kellogg School of Management Cases, vol. no.
Type: Case Study
ISSN: 2474-6568
Published by: Kellogg School of Management

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Article
Publication date: 6 June 2016

Matthew E. Sarkees and M. Paula Fitzgerald

Off-label drug prescribing by healthcare providers is a growing practice. Yet, the US Food and Drug Administration bans the marketing of drugs for off-label uses. In…

Abstract

Purpose

Off-label drug prescribing by healthcare providers is a growing practice. Yet, the US Food and Drug Administration bans the marketing of drugs for off-label uses. In recent years, legal challenges by the pharmaceutical industry have chipped away government restrictions on off-label drug promotion. Although the changing legal landscape has been discussed, this paper aims to examine how key stakeholders and policy-makers might interact to provide a more transparent marketing environment for off-label drug discussions in the patient–provider relationship.

Design/methodology/approach

Drawing on a variety of sources, the authors assess the current marketing landscape of off-label drugs and some of the issues that challenge the healthcare provider–patient relationship. The authors then examine opportunities to improve the off-label promotion environment and the relevant decision-making theories that key stakeholders need to consider when formulating marketing efforts and policies.

Findings

The authors suggest that fewer restrictions on truthful, non-misleading off-label drug promotion provide an opportunity to improve drug knowledge and, importantly, healthcare provider and consumer decision-making. Key stakeholders should consider, among other solutions, criteria for defining truthful information on off-label drugs, alternative methods of approval of off-label uses and ubiquitous icons to identify off-label prescribing to all stakeholders.

Originality/value

Rather than rehash the legal landscape of off-label drug promotion, this paper focuses on how the healthcare provider–patient relationship is impacted and how stakeholders can improve information flow in this changing environment.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 10 no. 2
Type: Research Article
ISSN: 1750-6123

Keywords

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Case study
Publication date: 20 January 2017

Jared D. Harris and Jenny Mead

Richard Alpert, senior partner at Evergreen Investments, must decide which of his two best employees to promote to the position of managing VP. He had initially preferred…

Abstract

Richard Alpert, senior partner at Evergreen Investments, must decide which of his two best employees to promote to the position of managing VP. He had initially preferred Charlie Pace over Daniel Faraday, but that decision had become less clear-cut when Alpert inadvertently overheard an office conversation and learned that Pace was taking Adderall, a stimulant primarily prescribed for people suffering from attention deficit/hyperactivity disorder (ADHD). Pace did not have ADHD and apparently obtained the medication by deceiving a physician. Alpert is faced with a number of questions, including whether it was fair to Faraday—or any other high-performing employee—to be passed over for promotion in favor of someone who illicitly boosted his performance with a substance he did not medically need.

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Article
Publication date: 1 April 1972

Lawrence Lamont, James Rothe and Charles Slater

Examines unit pricing of grocery products, a recent business response to the forces of consumerism in the USA, and its effects on the consumer, the retailer and the…

Abstract

Examines unit pricing of grocery products, a recent business response to the forces of consumerism in the USA, and its effects on the consumer, the retailer and the manufacturer. States that, as a pricing device, unit pricing is not entirely new, as products such as meats, dairy products and many fresh fruits and vegetables have been unit priced for years. Concludes that, before the full impact of unit pricing can be assessed, additional research questions need to be answered.

Details

European Journal of Marketing, vol. 6 no. 4
Type: Research Article
ISSN: 0309-0566

Keywords

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Article
Publication date: 6 September 2011

Fadi M. Alkhateeb, Patricia Baidoo, Marija Mikulskis Cavana, Danielle Gill, Amanda Howell, Babak Mehraeen and Carrie Weidner

Pharmaceutical sales representatives (PSRs) have been shown to influence the prescribing patterns of physicians. Some of the blame has been shifted from physicians to PSRs…

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Abstract

Purpose

Pharmaceutical sales representatives (PSRs) have been shown to influence the prescribing patterns of physicians. Some of the blame has been shifted from physicians to PSRs due to perceived inadequacies in PSRs' education and certification. The purpose of this paper is to review the literature regarding the current certification requirements for PSRs, motivation for nationally standardized certification and the controversy surrounding pharmaceutical detailing impact on physicians' prescribing behavior.

Design/methodology/approach

Articles related to certification for PSRs were identified via searches of PubMed and IPA from inception to March 2011. Search terms included PSRs, PSRs certification, PSRs registration, PSRs education, and PSRs requirements. Articles describing the roles and responsibilities of PSRs, physician and public perception of PSRs, certification processes, and the future of PSRs' roles were included. An internet search was also performed to identify articles in the lay press related to this topic.

Findings

This paper shows that the certification for PSRs may become necessary, or even required, to help ensure that the prescribing patterns of physicians are not negatively affected due to false information coming from the PSRs. Therefore, ensuring that PSRs are well certified can lead to better health outcomes for patients. Although pharmaceutical companies do not require certification to gain employment as a sales representative, the certification provides a good knowledge base and insight into the industry.

Originality/value

The paper shows that appropriate training and certification of PSRs may be on the rise for this career path.

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Article
Publication date: 23 June 2020

Nicole F. Stowell, Carl Pacini, Martina K. Schmidt and Nathan Wadlinger

This study aims to increase awareness and educate the reader about health-care fraud targeting seniors in the USA to help stakeholders better understand, recognize and…

Abstract

Purpose

This study aims to increase awareness and educate the reader about health-care fraud targeting seniors in the USA to help stakeholders better understand, recognize and prevent this type of fraud.

Design/methodology/approach

This paper collects statistics on the current state of health care frauds committed against seniors, and examines related cases and laws.

Findings

The authors find this type of fraud is highly prevalent and expected to increase. Current laws preventing this fraud from occurring are multifold and complex. While prevention strategies through law enforcement have been somewhat successful, a reduction in resources may put seniors at an increased risk in the years to come.

Research limitations/implications

Without additional prevention strategies, the problem will likely escalate with a growing population of older adults. This study encourages further research into effective prevention strategies and methods to fight health-care fraud against seniors.

Practical implications

Health-care fraud and its associated costs pose a significant threat to the society and economy of the USA. Reducing this fraud will not only reduce the costs to the US economy but also improve the physical and mental well-being of senior victims, reduce their mortality and hospitalization rates and improve the public trust placed to health-care providers.

Originality/value

This study highlights how health-care fraud is committed against seniors. With the projected trend of an aging US population, educating stakeholders, increasing awareness and applying tools to protect seniors will be important to reduce the absolute scope of this problem in the future.

Details

Journal of Financial Crime, vol. ahead-of-print no. ahead-of-print
Type: Research Article
ISSN: 1359-0790

Keywords

Abstract

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 8 no. 3
Type: Research Article
ISSN: 1750-6123

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Article
Publication date: 29 April 2020

Geeta Marmat, Pooja Jain and P.N. Mishra

The purpose of this paper is to examine and review the available literature on ethical/unethical behaviour of pharmaceutical companies and to determine the ethical issues…

Abstract

Purpose

The purpose of this paper is to examine and review the available literature on ethical/unethical behaviour of pharmaceutical companies and to determine the ethical issues, unethical behaviour by analysing, summarising and categorising the factors related to these issues and unethical behaviour as were studied during the period 2008-2017. Essentially, this paper presents a critical analysis of the available literature on the subject and avenues for future research.

Design/methodology/approach

This paper adopted the systematic review approach to achieve the purpose of this study and examines the most relevant literature from online existing database sources, available between 2008-2017 by using the keyword search method. Then studies are categorised and summarised, using previously developed theories and frameworks, which have provided evidence to the universal consensus that ethical behavioural outcomes are dependent on the interplay of individual, organisational and environmental factors and have reordered to fulfil the purpose.

Findings

The findings identify that ethical issues related to pharmaceutical companies as were studied during the period 2008-2017 are drug pricing, drug safety and gift-giving. The organisational variables appeared to be the dominant cause of these ethical issues and unethical practices along with other determinants such as environmental and stakeholders. A large number of studies were in the western country context. Theoretical research has studied more comparatively empirical studies.

Research limitations/implications

This review provides insights for understanding the ethical issues, unethical behaviour and determinants related to these issues of pharmaceutical companies and provides insights where the literature is standing. This review only includes studies between 2008-2017, which are related to the ethical issue of pharmaceutical companies, therefore, the view is only of the past 10 years papers. This review provides gaps and insight into the source of ideas for future research and will help the researchers in guiding ethics-related information in the context of pharmaceutical companies.

Practical implications

This study will help the practitioners and policymakers in informing about the issues that required the urgent need to solve and will shed some light to focus and formulate strategies for successful competitive advantage. This study will help researchers who are seeking information related to ethics and ethical behaviour in pharmaceutical companies.

Originality/value

To the best of my knowledge, this review of understanding ethical/unethical behaviour in pharmaceutical companies of the past 10 years between 2008-2017 has not been done to date. This study is filling the gap by bringing all the information about ethics in pharmaceutical companies at one place, which works as an index of ethics-related study in this specific pharmaceutical company context.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 14 no. 3
Type: Research Article
ISSN: 1750-6123

Keywords

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Article
Publication date: 10 May 2011

Jonathan Murphy

The purpose of this paper is to critically examine the international NGO Transparency International's (TI) role in combating corruption, focusing particularly on TI's…

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2705

Abstract

Purpose

The purpose of this paper is to critically examine the international NGO Transparency International's (TI) role in combating corruption, focusing particularly on TI's response to the global financial crisis of 2008.

Design/methodology/approach

The paper is based on a review of scholarly articles, newspaper reports, and TI publications.

Findings

The paper concludes that TI's uncritical approach to the functioning of international capitalism limits its ability to understand and challenge the systemic causes of corruption. Further, TI's attention to the manifestations rather than causes of corruption leads it to unfairly identify corruption as a failing of the global South rather than an inherent feature of international capitalism.

Originality/value

The paper demonstrates how TI's failure to address the widespread unethical conduct which was at the root of the global financial crisis derives from the organization's partial, legalistic and superficial definition of corruption.

Details

Critical perspectives on international business, vol. 7 no. 2
Type: Research Article
ISSN: 1742-2043

Keywords

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