The Case of Synthroid (A): Marketing a Drug Coming Off Patent

2017 ◽  
pp. 1-19
Author(s):  
Alice M. Tybout ◽  
Julie Hennessy ◽  
Natalie Fahey ◽  
Charlotte Snyder
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Ethical Issues ◽  
The United States ◽  
Insurance Companies ◽  
List Type ◽  
Generic Competition ◽  
Global Challenge ◽  
History Of ◽  
Competitive Products

The case tells the story of Synthroid from its development in 1958 as the first synthetic thyroxine molecule to its competition against generic equivalents in 2004. The case introduces students to the pharmaceutical industry, its practices, and some of the complexities of pricing and drug choice, with drug manufacturers, insurance companies, physicians, pharmacists, and patients all playing a role. It also provides a primer on hypothyroidism, its symptoms, and its treatment.Because Synthroid was developed and introduced before FDA regulations and drug standards of identity were fully established, it was difficult for competitors to get their drugs certified as identical to Synthroid. Through a series of efforts with physicians, especially endocrinologists, Synthroid's owners were able to maintain the perception for forty-six years that Synthroid was uniquely effective. In 2004, however, the FDA declared several competitive products to be bioequivalent to Synthroid, which posed a significant challenge to its owner, Abbott Laboratories. Students are challenged to consider options to maintain the drug's unit volume, revenue, and/or profit in these difficult circumstances.The case is written in two parts. The (A) case provides background on the history of the drug, the pharmaceutical industry and its marketing practices, and hypothyroidism and its treatment, and it concludes in 2004 as Abbott's marketers face the impending challenge of defending the Synthroid business against generic competition. The (B) case describes what Abbott actually did to maintain its share in the United States and outlines its strategy in India, a market without patent protection for pharmaceuticals.After analyzing the case students should be able to: Describe strategies that branded competitors can use to defend their business from lower-priced competition Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

The Case of Synthroid (B): Marketing a Drug Coming Off Patent

2017 ◽  
pp. 1-8
Author(s):  
Julie Hennessy ◽  
Alice M. Tybout ◽  
Natalie Fahey ◽  
Charlotte Snyder
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Ethical Issues ◽  
The United States ◽  
Insurance Companies ◽  
List Type ◽  
Generic Competition ◽  
Global Challenge ◽  
History Of ◽  
Competitive Products

The case tells the story of Synthroid from its development in 1958 as the first synthetic thyroxine molecule to its competition against generic equivalents in 2004. The case introduces students to the pharmaceutical industry, its practices, and some of the complexities of pricing and drug choice, with drug manufacturers, insurance companies, physicians, pharmacists, and patients all playing a role. It also provides a primer on hypothyroidism, its symptoms, and its treatment.Because Synthroid was developed and introduced before FDA regulations and drug standards of identity were fully established, it was difficult for competitors to get their drugs certified as identical to Synthroid. Through a series of efforts with physicians, especially endocrinologists, Synthroid's owners were able to maintain the perception for forty-six years that Synthroid was uniquely effective. In 2004, however, the FDA declared several competitive products to be bioequivalent to Synthroid, which posed a significant challenge to its owner, Abbott Laboratories. Students are challenged to consider options to maintain the drug's unit volume, revenue, and/or profit in these difficult circumstances.The case is written in two parts. The (A) case provides background on the history of the drug, the pharmaceutical industry and its marketing practices, and hypothyroidism and its treatment, and it concludes in 2004 as Abbott's marketers face the impending challenge of defending the Synthroid business against generic competition. The (B) case describes what Abbott actually did to maintain its share in the United States and outlines its strategy in India, a market without patent protection for pharmaceuticals.After analyzing the case students should be able to: Describe strategies that branded competitors can use to defend their business from lower-priced competition Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

Patent Protection

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
Pharmaceutical Industry ◽  
Strategic Behavior ◽  
Patent Protection ◽  
The United States ◽  
Marginal Production ◽  
System P ◽  
Advanced Economies ◽  
Patent Laws ◽  
Short Run ◽  
Innovative Drugs

Patent protection, innovation, and profitability are all intimately connected in the pharmaceutical industry. Without patent protection there would be no marketing exclusivity, and competitors would immediately enter any market where there was a new successful drug, eventually driving price down to the marginal production cost. Future R&D would never take place because there would be no way for firms to earn a yield on those investments in developing new pharmaceuticals. Patents, however, entail societal cost, because they raise the diffusion cost of knowledge and makes some innovative drugs prohibitively expensive in the short run. This chapter examines key patent laws applicable to the pharmaceutical industry, including category, duration, scope, infringement, and ground for challenge, both in the United States and in other advanced economies. Examples of strategic behavior by branded and generic firms are discussed. The chapter also provides a review of recent literature critical of the patent system.

Industrial life insurance, public health campaigns, and public communication of science, 1908-1951

1992 ◽  
Vol 1 (4) ◽  
pp. 347-365 ◽  
Author(s):  
Bruce V. Lewenstein
Keyword(s):  
Public Health ◽  
Life Insurance ◽  
The United States ◽  
Private Life ◽  
Insurance Companies ◽  
Public Communication ◽  
Health Campaigns ◽  
History Of ◽  
Communication Of Science ◽  
Public Health Campaigns

During the first half of the twentieth century, private life insurance companies in the United States provided an important locus for the public communication of science, through their support of public health campaigns. This paper provides a history of how and why three companies (the Metropolitan, the Prudential, and the John Hancock life insurance companies) drew on their strength in `industrial' life insurance (sold to the lower classes at low, weekly rates) to engage in public health reforms. Only the Metropolitan and the Hancock, however, became active in public communication of health information. The paper suggests that four key factors provided the context for the companies' activities: (1) legislative and social pressure for reform; (2) increases in profits associated with healthier (and therefore longer-lived) customers; (3) ideals of social reform held by individuals in positions of bureaucratic power within the insurance organizations; and (4) organized machinery for weekly contact with and distribution of information to policyholders as a result of the nature of industrial life insurance.

Developing a Legislative Pathway for Biosimilars in the United States

2009 ◽  
Vol 6 (4) ◽  
pp. 295-302
Author(s):  
Henry A. Waxman
Keyword(s):  
United States ◽  
Pharmaceutical Industry ◽  
The United States ◽  
High Price ◽  
Approval Process ◽  
Generic Competition ◽  
Drug Prices ◽  
Life Saving ◽  
Lower Drug ◽  
The Eu

Biologies are one of the fastest growing, most important, and most expensive segments of the pharmaceutical industry. The high price of biologies in the United States is making these life-saving drugs unaffordable for many Americans and creating unsustainable burdens on purchasers. While the EU has created an abbreviated approval process for biosimilars, there is no explicit legislative pathway in the United States that would enable generic competition for biologics. The Promoting Innovation and Access to Life-Saving Medicine Act would provide such a generic pathway for biologics, using competition to lower drug prices. The bill provides an appropriate balance between access to affordable medicine and retaining incentives for innovation.

scholarly journals Bibliometric Analysis of Global Scientific Research on SARS-CoV-2 (COVID-19)

2020 ◽  
Author(s):  
Fatemeh Rafiei Nasab ◽  
Fakher Rahim
Keyword(s):  
Research Performance ◽  
Exclusion Process ◽  
Unknown Origin ◽  
The United States ◽  
Impact Factors ◽  
List Type ◽  
History Of ◽  
Cooperative Institutions ◽  
Academy Of Sciences ◽  
Published Research

AbstractBackground and AimSince late 2019, an unknown-origin pneumonia outbreak detected in Wuhan city, Hubei Province, China. We aimed to build a model to qualitatively and quantitatively assess publications of research of COVID-19 from 2019 to 2020.Materials and MethodsData were obtained from the Web of Science (WOS), PubMed, and Scopus Core Collection on March 02, 2020, and updated on March 10. We conducted a qualitative and quantitative analysis of publication outputs, journals, authors, institutions, countries, cited references, keywords, and terms according to bibliometric methods using VOS viewer c software packages.ResultsInitially, we identified 227 papers, of which after an exclusion process, 92 studies were selected for statistical analyses. China accounted for the highest proportion of published research (44 papers, 40.48%), followed by the United States (21 papers, 19.32%), and Canada (7 papers, 6.44%). Adjusted by gross domestic product (GDP), ranked first, with 0.003 articles per billion GDP. In total, the top 10 journals published 47 articles, which accounted for 51.08% of all publications in this Feld. A total of 6 studies (05.52%) were supported by National Natural Science Foundation of China. Chinese Academy of Sciences ranked second 2, 2.76%).ConclusionBibliometric and visualized mapping may quantitatively monitor research performance in science and present predictions. The subject of this study was the fast growing publication on COVID-19. Most studies are published in journals with very high impact factors (IFs) and other journals are more interested in this type of research.HighlightsBibliometric description and mapping provided a birds-eye view of information on Covid-19 related researchReaders to comprehend the history of published Covid-19 articles in just a few minutes.We evaluated the research strength of countries and institutions,Scholars might refer to in order to find cooperative institutions.During our research using the selected database, we tried to guarantee comprehension and objectivity.

The other Drug Lords

1993 ◽  
Vol 23 (2) ◽  
pp. 263-273 ◽  
Author(s):  
Viveca Novak
Keyword(s):  
United States ◽  
Health Care ◽  
Pharmaceutical Industry ◽  
Patent Protection ◽  
The United States ◽  
Government Support ◽  
The Other ◽  
Pharmaceutical Firms ◽  
Drug Companies ◽  
Care Costs

To gain an understanding of how hard it will be to control skyrocketing health care costs in the United States, consider one small part of the health care system: the pharmaceutical industry. Every time Congress threatens to crack down on drug costs or reduce government support for the industry, the pharmaceutical firms crank out PAC contributions and deploy their lobbyists. The upshot: drug companies get to charge what they want while holding onto millions of dollars' worth of government giveaways, including tax breaks and generous patent protection.

scholarly journals Tell Me How It Ends: The Path to Nationalizing the U.S. Pharmaceutical Industry

2020 ◽  
pp. 755
Author(s):  
Fran Quigley
Keyword(s):  
Pharmaceutical Industry ◽  
Private Property ◽  
The United States ◽  
Executive Branch ◽  
Essential Medicines ◽  
The Public ◽  
Statutory Authority ◽  
Life Saving ◽  
History Of ◽  
The U.S

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history. It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry. U.S. statutory law already provides broad powers for the executive branch to immediately order the substantial manufacturing and distribution of patent-free medicines. That statutory authority should be immediately implemented and further expanded. In addition, U.S. constitutional law justifies a full seizure of all industry assets. Given the pharmaceutical industry’s substantial reliance on government funding and licensing, along with the industry’s widespread malfeasance that harms the public welfare, the amount of compensation for this seizure will be limited. That seizure and compensation will finally conclude the tragic era of medicines profiteering and launch a new system that restores life-saving medications to their rightful role as affordable, accessible public goods.

Ethical Issues in Newborn Screening

2016 ◽  
Author(s):  
Jeffrey R. Botkin
Keyword(s):  
Newborn Screening ◽  
Ethical Issues ◽  
New Technology ◽  
The United States ◽  
Legal Issues ◽  
Screening Tests ◽  
History Of ◽  
Ethical And Legal Issues ◽  
The 1960S ◽  
Developed World

Many new parents have little awareness of the battery of screening tests that are routinely conducted on newborns in the United States and the developed world. Newborn screening, one of the most significant achievements in public health over the past 50 years, invites ongoing debate over a number of ethical and legal issues that have been part of the newborn screening landscape since the inception of the programs in the 1960s. This chapter reviews the history of newborn screening, outlines some of the key ethical and legal issues raised by these programs, and offers a prediction about how new technology may change these systems over the next few decades.

scholarly journals Sejarah Perbandingan Sistem Pendaftaran Paten Di Amerika Serikat Dengan Di Indonesia

2021 ◽  
Vol 2 (1) ◽  
pp. 16
Author(s):  
Elisa Sugito ◽  
Erwin Syahruddin
Keyword(s):  
United States ◽  
Legal History ◽  
Patent Protection ◽  
The United States ◽  
Industrial Applications ◽  
European Countries ◽  
Registration System ◽  
Patent Rights ◽  
History Of ◽  
History Approach

Patent protection in a country cannot be separated from the registration system adopted in that country. In the United States the patent registration system is based on the first-to-invent principle. Even though the United States uses the first-to-invent principle, the United States also regulates protection requirements as European countries, Japan and Indonesia are in the form of new discoveries, containing inventive steps, and can be applied in industry. Meanwhile in Indonesia, the patent protection system used is the first to file system, which is a system that grants patent rights to those who first register a new invention in accordance with the requirements. The purpose of this research is to study and analyze the comparative history of the patent registration system in the United States with the patent registration system in Indonesia. The type of research method used is normative legal research with a comparative law approach and a legal history approach. The results of the study found that patent protection in European countries, the United States, Japan and Indonesia has similarities in protection requirements that regulate novelty, inventive steps, and industrial applications.

Special Considerations for Evaluation and Treatment of Spanish-Speaking Patients with Cleft Palate

2016 ◽  
Vol 1 (5) ◽  
pp. 41-49
Author(s):  
Ellen Moore
Keyword(s):  
Cleft Palate ◽  
The United States ◽  
Culturally Competent ◽  
Speech Language Pathology ◽  
Spanish Speaking ◽  
Appropriate Treatment ◽  
Oral Pressure ◽  
Language Pathology ◽  
History Of ◽  
Spanish Speaking Population

As the Spanish-speaking population in the United States continues to grow, there is increasing need for culturally competent and linguistically appropriate treatment across the field of speech-language pathology. This paper reviews information relevant to the evaluation and treatment of Spanish-speaking and Spanish-English bilingual children with a history of cleft palate. The phonetics and phonology of Spanish are reviewed and contrasted with English, with a focus on oral pressure consonants. Cultural factors and bilingualism are discussed briefly. Finally, practical strategies for evaluation and treatment are presented. Information is presented for monolingual and bilingual speech-language pathologists, both in the community and on cleft palate teams.

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