Journal articles on the topic 'Brand-name pharmaceutical company'
To see the other types of publications on this topic, follow the link: Brand-name pharmaceutical company.
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 19 journal articles for your research on the topic 'Brand-name pharmaceutical company.'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
1
Xie, Jin, and Joseph Gerakos. "The Anticompetitive Effects of Common Ownership: The Case of Paragraph IV Generic Entry." AEA Papers and Proceedings 110 (May 1, 2020): 569–72. http://dx.doi.org/10.1257/pandp.20201029.
Full textAbstract:
Brand-name pharmaceutical companies often file lawsuits against generic drug manufacturers that challenge the monopoly status of patent-protected drugs. Institutional horizontal shareholdings, measured by the generic shareholders' ownership in the brand-name company relative to their ownership in the generic manufacturer, are significantly positively associated with the likelihood that the two parties enter into a settlement agreement in which the brand pays the generic manufacturer to stay out of the market.
2
Lexchin, Joel, Sharon Batt, Devorah Goldberg, and Adrienne Shnier. "National patient groups in Canada and their disclosure of relationships with pharmaceutical companies: a cross-sectional study." BMJ Open 12, no. 3 (March 2022): e055287. http://dx.doi.org/10.1136/bmjopen-2021-055287.
Full textAbstract:
ObjectivesThis study investigates the information and policies that Canadian patient groups post on their publicly available websites about their relationships with pharmaceutical companies.DesignCross-sectional study.SettingCanadian national patient groups.ParticipantsNinety-seven patient groups with publicly available websites.InterventionsEach patient group was contacted by email. Information from patient groups’ websites was collected about: total annual revenue for the latest fiscal year, year revenue was reported, revenue from pharmaceutical company donors, purpose of the donation, presence of donors’ logos on the website and hyperlinks to donors’ websites, previous and current employment information about board members and staff, external audits about the group’s finances and whether the group endorses products made by donors. Analysis of publicly available policies looking at: board and/or advisory board, acceptance of donations and revenue generation, independence of decision-making, endorsements, assistance to and/or interactions between patient members from a donor or another company/person acting on behalf of a donor and audits/monitoring/compliance.Primary and secondary outcome measuresNumber of patient groups posting information on their websites about their relationships with pharmaceutical companies; the presence and contents of patient group policies covering different topics about relationships with pharmaceutical companies.ResultsFifty-three (54.6%) of 97 groups reported donations from pharmaceutical companies. Forty-one (42.3%) groups showed the logos of pharmaceutical companies on their websites and 22 (53.7%) had hyperlinks to pharmaceutical company websites. Twenty-five (25.8%) of these groups endorsed pharmaceutical products produced by brand-name companies that had donated to the groups. Twenty-six (26.8%) groups had policies that dealt with relationships with pharmaceutical companies.ConclusionsPharmaceutical industry funding of the included patient groups was common. Despite this, relatively little information was provided on patient group websites about their relationships with pharmaceutical companies. Only 26 out of 97 groups had publicly available policies that directly dealt with their relationships with pharmaceutical companies.
3
Liang, Zhiwen. "Regulatory exclusivity protection for undisclosed test data in China: an innovative approach to implementing the TRIPS Agreement." Queen Mary Journal of Intellectual Property 10, no. 1 (February 19, 2020): 115–27. http://dx.doi.org/10.4337/qmjip.2020.01.05.
Full textAbstract:
Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.
4
Rosina, Mônica Steffen Guise, and Lea Shaver. "Why are Generic Drugs Being Held up in Transit? Intellectual Property Rights, International Trade, and the Right to Health in Brazil and beyond." Journal of Law, Medicine & Ethics 40, no. 2 (2012): 197–205. http://dx.doi.org/10.1111/j.1748-720x.2012.00658.x.
Full textAbstract:
Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have witnessed more than 100-fold price reduction for antiretroviral (ARV) drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world.
5
Mistry, Vimesh R., Neeta J. Kanani, and Kuntal S. Thacker. "A critical evaluation of promotional drug literatures available with prescribers at a tertiary care teaching hospital in Gujarat, India." International Journal of Basic & Clinical Pharmacology 11, no. 2 (February 23, 2022): 167. http://dx.doi.org/10.18203/2319-2003.ijbcp20220417.
Full textAbstract:
Background: Promotional literature provided by the pharmaceutical companies is one of the important marketing strategies to prescribe. Many of these literatures do not follow ethical guidelines and contain biased and irrelevant information that may cause irrational prescribing. So we did this study with an aim to check the credibility, reliability and authenticity of the PDLs available with prescribers.Methods: Promotional drug literatures were analyzed based on various parameters and guidelines provided by world health organization. Statistical analysis was done using Microsoft Excel.Results: A total 395 promotional drug literatures were analyzed and very few of them fulfilled the ethical criteria for drug promotion. Most of them focused on providing information about generic name, brand name manufacture company name and claims about efficacy. Few of them focused on safety of drugs as less information provided about adverse reaction, precaution and drug-drug interaction. Many of them contain space occupying unnecessary pictures.Conclusions: It can be concluded that the majority of the promotional advertisements that were given to the prescribers do not follow ethical guidelines and were not able to improve rational prescribing but only have commercial benefits.
6
Harrop, Chris, John Read, Jim Geekie, and Julia Renton. "An Independent Audit of Pharma Influence in Public Mental Health Trusts in England." Ethical Human Psychology and Psychiatry 20, no. 3 (December 1, 2018): 156–68. http://dx.doi.org/10.1891/1559-4343.20.3.156.
Full textAbstract:
Without data, many people may think pharmaceutical companies' influence over mental health services is negligible. We audited the marketing activities of, and payments to, drug companies in relation to public mental health services in England. Forty-three of 53 Trusts responded to Freedom-of-Information-Act requests. Trusts' policies varied in covering seven activities: from 86% (gifts) to 37% (leaflets). In practice, industry-sponsored training events (51%) and direct talks (40%) were common (averaging 36 events or talks per Trust annually). Only 22% of Trusts produced legally required Conflicts-of-Interests registers; and 14% had none. All 22 Trusts that reported which company received the largest share of their drug expenditure named the same company. On average, Trusts spent 44% of their drugs budget on long-acting injectable antipsychotics (13% to 77%) and 32% on brand name drugs (5%–74%). Five Trusts ban the Pharma marketing activities investigated. Independent post-qualification medical education, and marketing-bans, are needed to avoid over-medicalized practice.
7
Karas, Laura. "Privacy as the Price of Drug Access." Science and Technology Law Review 23, no. 1 (March 7, 2022): 50–141. http://dx.doi.org/10.52214/stlr.v23i1.9390.
Full textAbstract:
In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.
8
Dass, Ervilla. "An observational study of various drug promotional advertising brochures: with an emphasis on World Health Organization ethical criteria for medicinal drug promotion." International Journal of Basic & Clinical Pharmacology 7, no. 7 (June 22, 2018): 1280. http://dx.doi.org/10.18203/2319-2003.ijbcp20182425.
Full textAbstract:
Background: Drug promotional literature (DPLs) is an integral approach of pharmaceutical marketing strategy, which can almost influence a physician to prescribe definite variety of medicine from a particular company. The objective was to evaluate the accuracy, consistency, and validity of the information in accordance with the World Health Organization (WHO) ethical criteria for medicinal drug promotion.Methods: This was an observational study, in which total 100 DPLs were sorted out to evaluate whether the information is consistent/relevant with that presented by the criteria laid down by the WHO guidelines; such as nature of claims, pictorial content presented, cited references, the indication and significance of various data such as figure, graphs, table and clinical data.Results: From all the 100 promotional literatures sorted out, all showed the INN name and brand name, amount of active ingredient, dosage form and name and address of manufacturers/distributers was shown in all; adjuvants known to cause problem were not shown. Moreover, approved therapeutic uses were clearly mentioned in 35, 48 were having pictures presented, scientific graphs and clinical data were shown in 19.Conclusions: The results reveal that, majority of DPLs satisfied only half of the WHO criteria for rational drug promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated information in DPLs may mislead and result in irrational prescription. Therefore, physicians should critically evaluate DPLs regarding updated scientific evidence required for quality patient care.
9
Chadha, Alka. "Daiichi Sankyo's generic (mis) adventure: the Ranbaxy takeover." Emerald Emerging Markets Case Studies 2, no. 8 (October 17, 2012): 1–10. http://dx.doi.org/10.1108/20450621211308122.
Full textAbstract:
Subject area The case offers a study of change management in the pharmaceutical industry in India. Study level/applicability The case is designed for undergraduate and postgraduate students to examine strategic decisionmaking in the context of mergers and acquisitions (M&As), firm capabilities and management practices. In particular, it has important pedagogical lessons for businesses eager to start operations in emerging countries. Students learn to recognize the unique nature of the pharmaceutical market and the factors affecting the demand and supply of drugs, including the economics of generics. The case can be discussed in one class session of approximately one-and-a-half to two hours duration. Case overview In 2012, the pharmaceutical industry in India was undergoing dynamic changes. There was keen interest among MNC pharmaceutical giants to buy up Indian generic manufacturing companies since their revenues were drying up with the impending patent expirations of many blockbuster brand name drugs. Japan's Daiichi Sankyo's had taken over the largest Indian pharmaceutical company, Ranbaxy Laboratories, known for its heritage of process innovations and market leadership. However, after the acquisition, Ranbaxy slipped to third position in the domestic market and was facing multiple problems including net losses and falling share prices, cultural differences in management practices, recall of drugs from foreign markets and a US FDA ban on its manufacturing plants. Further, Ranbaxy had always been viewed as a national champion and a customer-friendly company but drug prices had increased after the merger causing problems of affordability. The new CEO of Ranbaxy was facing a dilemma: how to regain the company's position as the market leader. Students are asked to advise the CEO of Ranbaxy how to tackle the challenges arising from the integration of an Indian company with a Japanese company. More specifically, the case focuses on M&A as a strategy for growth and also touches on issues related to competition, regulation, innovation and corporate governance. Expected learning outcomes The case discusses the different motives behind the deal for Daiichi Sankyo and Ranbaxy and why it was a strategic move by both the alliance partners. The case also raises issues of corporate governance for the management of Ranbaxy and the need for a proactive corporate social responsibility (CSR) strategy. The case provides students with the opportunity to develop their analytical skills in a real-life setting and apply theoretical concepts to the consideration of the various issues raised by the acquisition deal. Supplementary materials Teaching notes are available; please consult your librarian for access.
10
Li, Xing, and Minyue Jin. "Technology transfer in prescription drug market." Journal of Modelling in Management 13, no. 2 (May 14, 2018): 495–518. http://dx.doi.org/10.1108/jm2-03-2017-0029.
Full textAbstract:
Purpose Many people in developing countries are suffering from serious diseases, such as HIV and tuberculosis. On the other hand, drug patents impact the availability of the drug for patients. Pharmaceutical technology transfer is widely used by domestic and foreign pharmaceutical enterprises because it promotes the availability of the drug for patients. The purpose of this paper, which is on drug technology transfer, is mainly to discuss how to solve the conflict between drug patent protection and public health from the perspective of the law, but not from the perspective of economics. To fill this gap, the authors introduce a model in the prescription drug market and analyze how a foreign manufacturer that produces brand name drugs authorizes a domestic enterprise that produces common drugs. Design/methodology/approach In this paper, the authors consider a situation that if the patent holders are provided a certain amount of compensation, then whether compulsory licensing would be an effective tool to promote competition and improve the availability of drugs. Furthermore, they also consider three different cooperation mechanisms, namely, fixed-fee contract, royalty contract and two-part tariff contract, under the case of technology transfer and give the condition of which contract would be better under different scenarios. Findings It is found that the product differentiation and the agent behavior of doctor in the domestic market have a deep impact on the foreign enterprise’s decision on technology transfer. If both fixed-fee contract and royalty contract are permitted, foreign enterprise will choose different transfer contracts under different conditions. Under two-part tariff contract, it is equivalent to a fixed-fee or royalty contract under certain conditions. Furthermore, all contracts can improve patients’ benefits, while the royalty contract and the two-part tariff contract would reduce importer’s social welfare under certain conditions. Originality/value Prescription drugs can treat many acute diseases and improve people’s quality of life. On the other hand, it requires investment in pharmaceutical research and development and is hard to afford the drug for the people living in poverty. This paper tries to solve the problem by introducing three cooperation contracts. The authors consider an innovative drug company and a regular drug company. The regular drug company can improve the quality of its drug by signing a technology transfer agreement with the innovative company. Three contracts are discussed in this paper; they are fixed-fee contract, royalty contract and two-part tariff contract. The authors examine the impact of different contracts on the companies’ profit, patients’ benefit and social welfare. It is found that quality differentiation of drugs and doctor behaviors can have large impacts on the company’s decision about technology adoption as well as contract choice strategies. In all of the three contracts, patients’ benefit improves, while the profit of the two companies and social welfare can increase or decrease under different contracts.
11
Attri, Rekha. "Anju Pharmaceuticals: riding the herbal wave." Emerald Emerging Markets Case Studies 7, no. 3 (July 24, 2017): 1–26. http://dx.doi.org/10.1108/eemcs-01-2017-0008.
Full textAbstract:
Subject area Marketing management, consumer behaviour, digital marketing. Study level/applicability This case can be used for students studying marketing management courses and also for elective courses on consumer behaviour, digital marketing and strategic management in an MBA programme. Case overview This case is about Anju Pharmaceuticals which dealt in the manufacture and sale of ayurvedic/herbal products such as Panchsudha, Zalim Lotion, Ruz, Vama, Mekado etc. in Madhya Pradesh, India. Started in the year 1983, the company had still not been able to make a mark in the market. For quite some time now Mitesh, the third-generation proprietor of the company, was continuously reading articles which discussed how there has been a positive shift in the consumer preferences for products having herbal ingredients. Indian fast-moving consumer goods (FMCG) companies such as Patanjali, Dabur, Marico were banking on herbal components in their various key products such as toothpaste, shampoo and hair oil to expand their market share and some of these Indian companies seemed to be growing faster than bigger multinationals including Hindustan Unilever and Procter & Gamble. With the changes in consumer perception towards herbal products, Mitesh was hopeful that if he could gear up his distribution it would result in improving the bottom-line of the company. He had also started receiving queries from interested clients for third-party manufacturing and packaging of the ayurvedic products under the desired brand name. Mitesh was very much aware that to improve his bottom-line, just relying on efficient distribution would not suffice and he would need to come up with strategic alliances and newer ways of doing the business rather than just following what had been the norm for the last few years. The idea of becoming a third-party manufacturer somehow did not excite Mitesh because he felt that by going in for third-party manufacturing he would never be able to establish the brand identity of Anju Pharmaceuticals. He wanted his company to ride the FMCG herbal wave but how and at what cost were the big questions facing him. Expected learning outcomes After the successful completion of this case, the readers would be able to accomplish the following: gain insights into the problems faced by small businesses when they want to scale up their business. Get insights into the challenges/difficulties of adopting e-commerce by a small organization. Be aware of the changing consumer preferences for herbal and ayurvedic products and how companies are gearing up to cash on to the changing market opportunities. Comprehend the problem situation. Suggest ways of taking advantage of the current scenario to expand and grow the business. Supplementary materials Teaching notes are available for educators only. Please contact your library to gain login details or email support@emeraldinsight.com to request teaching notes. Subject code CSS 8: Marketing.
12
Daabes, Ajayeb S. Abu, Mohammed Ananzeh, and Faris El-Dahiyat. "Proposing a pharmaceutical brand naming framework based on techniques extracted from decoding current drug names." International journal of health sciences, June 21, 2022. http://dx.doi.org/10.53730/ijhs.v6ns5.9341.
Full textAbstract:
This study endeavors to make a valuable contribution to the brand naming theory especially in the pharmaceutical field. It sheds light on several techniques used by companies to name their drugs as per the regulations and trends in the market. The objective of this study is to build an applicable brand naming framework after exploring techniques that are used to generate and invent pharmaceutical brand names. An exploratory qualitative study is conducted using official public data from the Jordan National Drug Formulary (JNDF) in Jordan. A simple four-step process is outlined to decode the drugs’ brand naming techniques: (1) Select, (2) Analyze, (3) Extract, and (4) Suggest. A deep componential analysis of 57 drug brand names has been carried out for each component of the drug name by finding linkages between the syllables and relevant parts in the generic name, chemical name, company name, and/or otherwise. The researchers then extracted number of techniques that are used by pharmaceutical companies. These techniques were translated into an adaptive framework which proposes different variables under which drug brand names can be classified.
13
Alssageer, Mustafa Ali. "ANALYSIS OF INFORMATIVE AND PERSUASIVE CONTENT IN PHARMACEUTICAL COMPANY BROCHURES IN LIBYA." Libyan Journal of Pharmacy and Clinical Pharmacology 2 (December 5, 2013). http://dx.doi.org/10.5542/ljpcp.v3i0.9511882.
Full textAbstract:
Objective: To examine the patterns of promoted drugs, the quality of information provided, the references cited, and the persuasive techniques used in pharmaceutical brochures in Libya.Method: Cross-sectional analysis of pharmaceutical brochures collected between August and November 2010 from doctors’ offices in three cities: Tripoli, Benghazi and Sebha.Result: From 300 collected brochures, we took190 promotional materials for 132 promoted products. Antibiotics (n=52; 27%) made up the largest proportion. Cardiovascular products (n=39; 20.5%) came next, with antihypertensive agents (n=23) approximately six-tenths (58.9%) and statins (n=9) nearly a quarter (23%) of that class. Twenty seven products (14.2%) were gastrointestinal tract agents (GITs) and 10 of the GITs were proton pump inhibiters (PPIs). Over 90% of brochures provided the generic name, indications, dosage regimen and brief pharmacological effects of the drugs they advertised. However, information on contraindications, precautions, pregnancy and lactation, and adverse effects appeared in only 70.5% of advertisements. Drug Overdose information appeared in only 33% of brochures, and out of the 134 (70%) of brochures that cited references, only 28 (20.8%) of these brochures cited their references appropriately. Only four of the advertisements displayed the generic name as prominently as the brand name and most (n=136; 71.5%) used only the trade name in the prescribing information section. Graphical presentations, emotional texts and pictorial content appeared in 60%, 88.9%, and 96.3%of brochures respectively.Conclusion: Almost all brochures did not adhere to WHO ethical criteria for drug promotion and mostly relied on persuasive techniques .
14
Nandy, Mithun, and Dr Brajaballav Pal. "Pharmaceutical Marketing & Product Promotion: A Paradigm Shift in Indian Pharmaceutical Industry (IPI)." Adhyayan: A Journal of Management Sciences 5, no. 2 (February 16, 2016). http://dx.doi.org/10.21567/adhyayan.v5i2.8817.
Full textAbstract:
The Indian pharmaceuticals' market is third largest in terms of volume and thirteen largest in terms of value, as per a pharmaceuticals sector analysis report by equity master. The market is dominated majorly by branded generics which constitute nearly 70 to 80 per cent of the market. Considered to be a highly fragmented industry, consolidation has increasingly become an important feature of the Indian pharmaceutical market. India has achieved an eminent global position in pharma sector. Country also has a huge pool of scientists and engineers who have the potential to take the industry to a very high level. Indian pharmaceutical industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years, as per India Ratings, a Fitch Group company. Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country outside the US. In Indian Pharmaceutical Industry detailing has always been an integral part of doctors' communication for over the last three to four decades. All the Health Care Providers (HCPs) are struggling to manage their time schedule, the print communication gets poor attention with hardly 5-10% of the total message delivered at time. Many a times, the doctor says that he has seen the medical representative over and over again and asks the sales representative to just name the brand and/or leave samples and move on. All the cumulative hard work of the brand manager, marketing manager and the sales representative goes for a toss when the doctor does that. A major complaint of the field people, including managers, is that they cannot talk beyond the brand name and one or two points; just because they had a bad experience with the doctor not being receptive or not allowing them to speak more and the same has become a common phenomenon. With the advent of technology, video content, graphics, motion and interactivity, and newer digital tools are challenging this visual aid and redefining communication. This version of detailing adds an ‘e’ of electronic to it, making it completely different from the current mode of communication, where the electronic detailing aid is used by the medical representatives in person-to-person call. In this paper the researcher has given his endeavour to identify the key factors influencing adoption of e-detailing as a Pharmaceutical Marketing Communication by incorporating the views of Health Care Providers (HCPs) of India.
15
Bruner, Robert F. "Glaxo Italia, S.p.A.: The Zinnat Marketing Decision." Darden Business Publishing Cases, January 20, 2017, 1–21. http://dx.doi.org/10.1108/case.darden.2016.000135.
Full textAbstract:
In September 1990, the financial controller of this Italian subsidiary of a large pharmaceutical company must analyze the implications of two different strategies for introducing a new product into the Italian market: co-marketing distribution, in which Glaxo would permit another company to market the same product but under a different brand name; and direct sales, under which Glaxo's own sales force would be the sole channel of distribution. The tasks for the student are to scrutinize and correct financial forecasts contained in the case and then value the alternative cash flow streams. The purpose of the case is to exercise students' forecasting and valuation skills and to illustrate the application of discounted cash flow analysis to the choice of marketing policies.
16
Carrier, Michael. "Product Hopping." Journal of Commercial Biotechnology 23, no. 2 (August 30, 2017). http://dx.doi.org/10.5912/jcb795.
Full textAbstract:
One of the most pressing issues in antitrust law involves “product hopping.” A brand-name pharmaceutical company switches from one version of a drug (say, capsule) to another (say, tablet). The concern with this conduct is that some of these switches offer only a trivial medical benefit but significantly impair generic competition.The antitrust analysis of product hopping is nuanced. In the U.S., it implicates the intersection of antitrust law, patent law, the Hatch-Waxman Act, and state drug product selection laws. In fact, the behavior is even more complex because it involves uniquely complicated markets characterized by buyers (insurance companies, patients) who are different from the decision-makers (physicians).This article introduces the relevant U.S. laws and regulatory frameworks before exploring the five litigated cases.
17
Williams, Elana. "Tribal Sovereign Immunity as a Defense in Overcoming IPR Challenges of Brand Name Pharmaceutical Patent Validity at PTAB – Effects on the Industry." Pittsburgh Journal of Technology Law and Policy 18, no. 1 (March 28, 2018). http://dx.doi.org/10.5195/tlp.2018.216.
Full textAbstract:
Tribal sovereignty has been recognized by the American government since the establishment of the United States and tribal sovereign immunity has been a part of American jurisprudence for over a century. Tribal sovereign immunity continues to play an important role in modern times, especially in the last few years with the rise of inter partes review (IPR) proceedings stemming from the America Invents Act of 2011. IPR proceedings are filed with the United States Patent and Trademark Office (USPTO) and heard by the Patent Trial and Appeal Board (PTAB) as an alternative to or in conjunction with traditional patent litigation in the U.S. Court of Appeals for the Federal Circuit. Therefore, patent owners may have to defend their patents both at PTAB and in federal court.PTAB has recently granted its first motion to consider the issue of tribal sovereign immunity as it relates to patents covering the branded drug Restasis®. This case involves two giants of the pharmaceutical industry: Allergan PLC (Allergan), a brand name drug manufacturer who holds the Restasis® patents, and Mylan N.V. (Mylan), a generic pharmaceutical company.
18
"Generic Prescribing, Generic Substitution, and Therapeutic Substitution." Pediatrics 79, no. 5 (May 1, 1987): 835. http://dx.doi.org/10.1542/peds.79.5.835.
Full textAbstract:
Pressures generated by a constellation of professional consumer, legislative, and health care provider vider groups in this era of increasing health care costs have led to enactment of generic substitution laws in 50 states. The general acceptance of this concept, despite conflicting evidence that it has reduced the cost of prescription items to the consumer, has led to the concept of therapeutic substitution. Considerable confusion exists among health care professionals regarding the precise meaning of these concepts. Generic prescribing is the prescribing of a drug by a physician using the generic name. This leaves the choice of brand to the dispensing pharmacist. Generic substitution is a pharmacist-initiated act by which a different brand or an unbranded drug product is dispensed instead of a drug brand that was prescribed by the physician. This means substituting the same chemical entity in the same dosage form for one marketed by a different company. Therapeutic substitution is a pharmacist-initiated act by which a pharmaceutical or therapeutic alternate for the physician-prescribed drug is dispensed without consulting the physician. This denotes replacement of the prescribed drug with a chemically different drug within the same therapeutic category, eg, hydrochlorothiazide for furosemide; ranitidine for cimetidine; chloramphenicol for erythromycin. In 1976, the AAP Committee on Drugs published a commentary in Pediatrics (1976;57:275-277) on generic prescribing and concluded that "the lack of data on bioavailability and bioequivalence in children precludes blanket support of generic prescribing for infants and children." The Committee recently reviewed this issue and concluded that the situation has changed little during the past decade.
19
Zarei, Ehsan, Amir Ghaffari, Ali Nikoobar, Shayan Bastami, and Hasan Hamdghaddari. "Interaction between physicians and the pharmaceutical industry: A scoping review for developing a policy brief." Frontiers in Public Health 10 (January 12, 2023). http://dx.doi.org/10.3389/fpubh.2022.1072708.
Full textAbstract:
BackgroundPayments to physicians by the pharmaceutical industry are common, but recent evidence shows that these payments influence physician prescribing behavior in the form of increased prescription of brand-name drugs, expensive and low-cost drugs, increased prescription of payer company drugs, etc. Considering that these payments increase drug costs for patients and health systems, there is a public interest in controlling them. Therefore, this study aimed to identify and propose policy options for managing physician-pharmaceutical industry interactions in the context of Iran's health system.MethodsIn the first phase, a systematic search was conducted to identify relevant policies and interventions in Web of Science, PubMed, and ProQuest databases from 2000 to 2022. Then, the opinions of the research team and an expert group (physicians, health policy and transparency experts, and industry representatives) were used to categorize the interventions and propose policy options along with their advantages, disadvantages, and implementation considerations.ResultsIn the search, 579 articles were retrieved, and 44 articles were found suitable for the final analysis. Twenty-nine interventions and strategies were identified, and based on these; Five policy options were identified: prohibition, restriction, physician self-regulation, voluntary industry disclosure, and mandatory industry disclosure.ConclusionThe proposed policies in our study include advantages, challenges, and implementation considerations based on up-to-date evidence that can help policymakers use them to manage COI in physician-pharmaceutical industry interactions in Iran's health system. A combination of measures seems to help manage COI: firstly, using self-regulating physicians and industry to institutionalize transparency, and in the next step, implementing mandatory industry disclosure policies and establishing restrictions on some financial interactions.