Journal articles on the topic 'Brand-name pharmaceutical companies'
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1
Silber, Seth, and Kara Kuritz. "Product Switching in the Pharmaceutical Industry: Ripe for Antitrust Scrutiny?" Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 7, no. 2 (April 2010): 119–30. http://dx.doi.org/10.1057/jgm.2010.1.
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Since the Hatch-Waxman Act was enacted in 1984, generic drug companies have benefited from its provisions to facilitate approval of generic alternatives to brand-name pharmaceuticals. Upon generic entry, consumers of prescription drugs benefit from large discounts as brand manufacturers lose significant market share to these lower-priced alternatives. Over time, brand-name drug manufacturers have undertaken strategies, such as ‘product switching’ or ‘product hopping’, that may delay or prevent generic entry and protect their market share. Generic drug manufacturers, drug purchasers and antitrust authorities have begun looking to the antitrust laws to address these strategies and their impact on generic entry. This article discusses the regulatory framework under which pharmaceutical companies introduce new drugs, two prominent cases in which courts have wrestled with whether product switching violates the antitrust laws, factors that might support an antitrust claim for product switching, and the FTC's interest in challenging product switching.
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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.
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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.
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Xie, Jin. "Horizontal Shareholdings and Paragraph IV Generic Entry in the U.S. Pharmaceutical Industry." Antitrust Bulletin 66, no. 1 (January 11, 2021): 100–112. http://dx.doi.org/10.1177/0003603x20985797.
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The Federal Trade Commission frequently files complaints against “pay-for-delay” settlements between brand-name pharmaceutical companies and generic-drug manufacturers, the latter of which challenge the monopoly status of patent-protected drugs. I document than when the top 20 generic shareholders have more substantial financial interests in the brand, then the likelihood that the brand enters into a settlement agreement with the first generic to challenge the brand goes up. The result of such a settlement is a payment from brand to generic, in exchange for the generic’s delayed entry. Only after the first generic’s entry, a 180-day period of marketing exclusivity for that particular generic starts. Other generics can only market their drugs after that period expires. As such, the settlement between brand and the first generic extends the brand’s monopoly position. I conclude that horizontal shareholdings facilitate coordination between brand-name patent holders and generic challengers in response to the threat of entry.
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Fullerton, Thomas M., and Steven L. Fullerton. "Aggregate Online Brand Name Pharmacy Price Dynamics for the United States and Mexico." Economies 10, no. 5 (May 12, 2022): 112. http://dx.doi.org/10.3390/economies10050112.
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Virtual cross-border medical tourism allows many residents in the United States to purchase brand name medicines from companies in Mexico without travelling there. Monthly economic reports indicate that the online brand name pharmaceutical product prices in Mexico are noticeably lower than the corresponding internet prices in the United States. There have been very few econometric studies on how these prices are linked and the dynamic nature of those relationships. Results in this study indicate that online medicine prices in Mexico respond very rapidly to online prices changes in the high-price market.
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Moken, Merri C. "Fake Pharmaceuticals: How They and Relevant Legislation or Lack Thereof Contribute to Consistently High and Increasing Drug Prices." American Journal of Law & Medicine 29, no. 4 (2003): 525–42. http://dx.doi.org/10.1017/s0098858800002598.
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The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).
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Boumil, Marcia M., Emily S. Cutrell, Kathleen E. Lowney, and Harris A. Berman. "Pharmaceutical Speakers' Bureaus, Academic Freedom, and the Management of Promotional Speaking at Academic Medical Centers." Journal of Law, Medicine & Ethics 40, no. 2 (2012): 311–25. http://dx.doi.org/10.1111/j.1748-720x.2012.00666.x.
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Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges (AAMC), the American Board of Internal Medicine (ABIM) and the Institute on Medicine as a Profession (IMAP), and government bodies such as the Institute of Medicine (IOM) have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products.
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Ratheesh, R., Bindu Mohandas, and Bhaskaran K. "Evaluation of drug promotional brochures in a tertiary teaching hospital of Kannur, India." International Journal of Basic & Clinical Pharmacology 7, no. 6 (May 22, 2018): 1089. http://dx.doi.org/10.18203/2319-2003.ijbcp20182051.
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Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. WHO has framed guidelines for ethical drug promotion in 1988. The transparency of pharmaceutical advertisements is important because decision of the physician is likely to be influenced by the claims made by the pharmaceutical companies in the promotional drug brochures and pharmaceutical industries treat their marketing material as “educational material” for doctors. Authors did this study to analyze the information given on drug promotional brochures by the drug companies using ethical criteria of drug promotion by WHO 1988 and to verify the authenticity of the claims given by the pharmaceutical companies in drug promotional brochures.Methods: Cross sectional study extending from 1/8/2012 to 31/7/2013. 612 drug promotional brochures satisfied our inclusion criteria. Drug brochures were analyzed with WHO ethical criteria 1988 and further categorizing the data into type of claims, number and source of references. Validity of journal articles were checked by using a validity measure developed by Cardarelli.Results: Total 612 brochures satisfied inclusion criteria. INN was mentioned in 93.8% of collected brochures. Brand name was mentioned in 100% brochures. Content of active ingredients was mentioned in 92% of brochures. Name of the other ingredients known to cause problem 28.4% of brochures. Dosage form or regimen was mentioned in 23.2% of brochures. Approved therapeutic use mentioned in 65.7% brochures. Side effects and major adverse drug reactions were mentioned in 31.4% brochures. Precautions and contraindications and warnings were mentioned in 30.4% drug promotional brochures. Drug interactions were mentioned in 26.5% brochures. Name and address was mentioned by 69.1% brochures. There were 1144 claims and 739 references. Efficacy claims were 84.88% of the total claims. Main source of reference was from journal articles (74.1%) and among them 49.65% were randomized control trials. Only 47.94 % of the journal references were valid.Conclusions: Brochures were lacking in vital information which included contraindication, warning, precaution, name of the other ingredients known to cause problem hence companies were found violating WHO ethical criteria. Claims were not well supported with references. Less than half of the given journal references were only valid. This study highlights the need of healthcare professionals to remain cautious about promotional material presented by pharmaceutical representatives.
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Scheffer, Mario Cesar. "Interaction between pharmaceutical companies and physicians who prescribe antiretroviral drugs for treating AIDS." Sao Paulo Medical Journal 132, no. 1 (2014): 55–60. http://dx.doi.org/10.1590/1516-3180.2014.1321609.
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CONTEXT AND OBJECTIVE: Given that Brazil has a universal public policy for supplying medications to treat HIV and AIDS, the aim here was to describe the forms of relationship between physicians and the pharmaceutical companies that produce antiretrovirals (ARVs). DESIGN AND SETTING: Cross-sectional epidemiological study conducted in the state of São Paulo. METHODS : Secondary database linkage was used, with structured interviews conducted by telephone among a sample group of 300 physicians representing 2,361 professionals who care for patients with HIV and AIDS. RESULTS : Around two thirds (64%) of the physicians prescribing ARVs for HIV and AIDS treatment in the state of São Paulo who were interviewed declared that they had some form of relationship with pharmaceutical companies, of which the most frequent were receipt of publications (54%), visits by sales promoters (51%) and receipt of small-value objects (47%). CONCLUSIONS: Two forms of relationship between the pharmaceutical industry and physicians who deal with HIV and AIDS can be highlighted: facilitation of professionals' access to continuing education; and antiretroviral drug brand name promotion.
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Malik, Salma, Tejus Anantharamu, M. Fadil Salmani, Sapna Pradhan, and A. G. Mathur. "An analysis of adherence to the World Health Organisation guidelines pertaining to drug promotional literature by pharmaceutical firms." International Journal of Basic & Clinical Pharmacology 7, no. 12 (November 24, 2018): 2429. http://dx.doi.org/10.18203/2319-2003.ijbcp20184860.
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Background: Pharmaceutical companies used Drug Promotion Literatures (DPLs) as a major tool to advertise their new products. World Health Organization (WHO) has set some guidelines for promotion of drug literature. Thus, this study aimed to evaluate various DPLs for their accuracy and credibility as per WHO ethical criteria.Methods: This was an observational and cross-sectional study. Total 100 drugs advertisements published in various medical journals were collected from the library of the college. Advertisements were selected based on inclusion and exclusion criteria. The selected advertisements were evaluated based on the WHO ethical criteria for drug promotion.Results: From 100 advertisements, 73 were single drug whereas 27 were fixed drug combinations. Antimicrobials (16%) were the most promoted advertisements. Only 28% of the advertisements carried references to support their claim. Out of which majority (91.78%) were from journal articles. The generic name, brand name, names of active ingredients, manufacturer, distributor and dosage regimen were mentioned in majority of advertisements. Drug interactions (12%), contraindications (22%), precautions (24%) and side effects (22%) were least mentioned in the advertisements.Conclusions: It was observed that none of the advertisement followed all the guidelines laid down by WHO. Pharmaceutical companies should follow ethical regulatory measures to promote their product in various journals. The regulatory authority must ensure the pharmaceutical companies to follow ethical guidelines for publishing various drug promotional literatures.
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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.
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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.
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Ponomarova, Olena. "Some aspects of means of individualization on the market of medical and pharmaceutical services." Theory and Practice of Intellectual Property, no. 5 (June 11, 2021): 121–26. http://dx.doi.org/10.33731/52020.233749.
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Ponomarova O. Some aspects of means of individualization on the market of medical and pharmaceutical services. The article deals with some aspects of means of individualization in the market of medical and pharmaceutical services. Of particular importance is the identification of goods or services in the field of health care, in conditions of high competition in the pharmaceutical and medical markets, is for patients who consume (use) the product or service of this manufacturer, because brand awareness will not allow the patient to confuse one drug with another. Confusion in the names of medicines is quite common, but such confusion can lead to the appointment, purchase and use of a medicine with a similar name, which can have threatening consequences for human life and health.In the market of medical and pharmaceutical services, in most cases, we trace such means of individualization of participants in economic activities as trade names and trademarks (signs for goods and services). Individualization tools on the one hand individualize the entrepreneur (manufacturer) from a number of other participants in the market of medical and pharmaceutical services, and on the other - are a link between the manufacturer of the drug and the patient or between the doctor (health care facility / clinic) and the patient. A trade name is a designation under which an entity may act in a business relationship. Trademarks intended to identify and individualize the goods (services) of the manufacturer (provider) are usually associated with the name of the doctor who provides medical services or with the name of the medicinal product under which the medicinal product enters into commercial circulation and is sold on market of medical and pharmaceutical goods.There are many lawsuits regarding the similarity of the trade name of a medicinal product to another. In Ukraine, the owner of a trademark for a medicinal product may apply for protection of his rights against unfair competition to the Antimonopoly Committee of Ukraine and to the court for protection of infringed intellectual property rights to the mark.Companies that manufacture medicines in the process of creating a new drug name must remember that the main function of the brand name of the drug is to protect patients from misleading them, as well as to prevent medical errors due to the similarity of drug names, which can lead to to risks to life and health of patients. At the same time, the correctly and successfully chosen trade name of the drug plays an important commercial and legal role in the implementation of pharmaceutical companies in the market of medicines.Key words: means of individualization, trademark, medicine, pharmacy, intellectualproperty
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Latif, Ahmed, Muhammad Siddique Ansari, Muhammad Ibrahim Ansari, Rabia Malik, Abdul Ahad Sohoo, Firdous Sohoo, and Umaira Zaib. "Influences of Pharmaceutical Industry on Prescription Practices in Public and Private Hospitals of Islamabad- Pakistan." Pakistan Journal of Public Health 11, no. 1 (May 31, 2021): 24–29. http://dx.doi.org/10.32413/pjph.v11i1.284.
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Background: To explore the influences of pharmaceutical companies on prescription practices and to find out types of incentives of pharmaceutical companies on medical doctors in private and public hospitals in Islamabad, the capital city of Pakistan Methods: A qualitative exploratory study was conducted in 06 months May-Oct: 2017 in Islamabad (Capital City of Pakistan). Data were collected from doctors and pharmaceuticals representatives through snowballing sampling techniques through open ended questionnaire in which In-depth interviews were taken. In depth interviews were recorded, transcribed and coded. Qualitative sub-component was included to triangulate the data, sub themes and themes were generated. Results: Respondent’s prescription is a basically document in which we suggest minimum effective medication therapy to the patient, that is also cost effective and give maximum treatment to the patient. Few of the respondents are also agreeing on the point that most of the times patient itself influences to prescribe the particular product. Patient itself influences to prescribe the particular product that is redundant in its treatment regimen. Other respondents stated that prescription is varying from patient to patient and our priority is to give the medicine to the patient which shows good efficacy. Conclusion: Most doctors were maintaining protocol of prescription and using brand name of medicine. Pharmacists were visiting them on regular basis conditionally.
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Gautam, Sandhya Rani, Preeta Kaur Chugh, Ravinder Kr Sah, and C. D. Tripathi. "Critical appraisal of drug promotional literature using World Health Organisation guidelines." International Journal of Basic & Clinical Pharmacology 6, no. 8 (July 22, 2017): 2014. http://dx.doi.org/10.18203/2319-2003.ijbcp20173289.
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Background: Pharmaceutical marketing using drug promotional literatures is an important strategy adopted by the companies to promote their drugs. The primary objective of the present study is to compare the drug promotional literature of different pharmaceutical companies on the basis of World Health Organization (WHO) guidelines on ethical drug promotion.Methods: This observational, cross sectional study was conducted at a tertiary care hospital, Delhi. The promotional literature was evaluated in accordance with WHO guidelines, nature of claims, pictorial content presented in it and for the cited references.Results: A total of 208 promotional brochures were analysed. Only few (5.8%) of the promotional literature fulfilled all the criteria as mentioned by the guidelines. Nutritional supplements (27.9%) were the most promoted group of drugs. Pharmaceutical companies were most reluctant to provide information regarding contraindications (9.6%), adjuvants (11.5), side effects (10.6%) and drug interactions (9.6%). Generic name, brand name, dosage form, therapeutic indications were outlined in most of the brochures. Exaggerated emotional claims were made in 47.1% brochures, followed by that of efficacy in 39.4% and safety in 25% of brochures. Pictures of medicinal products outnumbered others with 39.9% followed by pictures of women, children and doctors with 20.7%, 17.3% and 13.5% respectively.Conclusions: Majority of the drug promotional literature did not comply with the ethical guidelines and was inadequate in terms of their adequacy, quality and reliability. Hence, it can be concluded that the majority of the promotional advertisements that are given to the prescribers are not able to spread awareness towards rational prescribing.
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Vyas, Pratit P., and Amol L. Bhave. "Critical appraisal of Drug Promotional Literatures (DPLs) as per World Health Organization (WHO) guidelines." International Journal of Basic & Clinical Pharmacology 7, no. 2 (January 23, 2018): 238. http://dx.doi.org/10.18203/2319-2003.ijbcp20180092.
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Background: The study was aimed to critically analyse Drug Promotional Literatures (DPLs) using WHO guidelines. This would help to create awareness about DPLs amongst healthcare providers thus encouraging the improvement of healthcare system.Methods: This cross sectional observational study was carried out at Department of Pharmacology, Medical College Baroda. DPLs were collected & critically analysed for consistency, accuracy, validity of the provided information as per WHO guidelines.Results: Out of total 616 DPLs collected, 371 satisfied the inclusion criteria. None of the DPL was fulfilling all criteria according to WHO guidelines. Most of DPLs were having information regarding; generic name / INN (98.39%), brand name (100%), amount of active ingredient per dosage (94.07%), approved therapeutic uses (84.91%), dosage form (91.37%) and name & address of manufacturers (91.91%). Of all the DPLs, information provided for safety parameters like; name of active ingredient known to cause problem (11.59%), dosage regimen (32.88%), side effects & drug reaction (14.56%), major drug interactions (14.02%) and precautions, contraindications and warning (14.29%) seemed to be grossly neglected. Total of 431 claims were evaluated, of which the most common type of claim was efficacy (55.45%). Relevant references to claims were present in (48.74%) DPLs. Total 203 references were evaluated from 371 DPLs, of which maximum reference were from journal article (74.38%).Conclusions: From this study, it was concluded that pharmaceutical companies didn’t follow the WHO guidelines for ethical drug promotion, thus failing to fulfil the rational promotion of drugs. Given the present findings physicians should be cautious about drawing conclusions regarding medicine based on DPLs provided by pharmaceutical companies.
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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.
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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.
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Iacocca, Kathleen, James Sawhill, and Yao Zhao. "Why brand drugs priced higher than generic equivalents." International Journal of Pharmaceutical and Healthcare Marketing 9, no. 1 (April 7, 2015): 3–19. http://dx.doi.org/10.1108/ijphm-01-2014-0005.
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Purpose – This paper aims to investigate why brand-name drugs are priced higher than their generic equivalents in the US market. The authors hypothesize that some consumers have a preference for brand names, which outweighs the cost savings realized by switching to generics. Consumers may prefer a brand drug because the brand may have a higher perceived quality due to advertising and other promotional activities. Additionally, individuals are habitual in their consumption of prescription drugs, which leads to continued use of the brand in the face of generic competition. Design/methodology/approach – The authors develop a structural demand model and proceed to estimate it using wholesale price and demand data from the years 2000 through 2004. Findings – The results of our analysis reveal that customers have a strong preference for brand drugs. In addition, consumers exhibit high switching costs for prescription drugs. Originality/value – Considering the price and quantity of prescriptions filled each day, determining why brand drugs do not lower their prices to compete with their generic equivalents is an important question. Unfortunately, the existing literature only acknowledges this counter-intuitive business practice, but does not mathematically explain it. The authors address this knowledge gap in literature and provide important insight for all players in this industry including consumers, pharmaceutical manufacturers and health insurance companies.
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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.
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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.
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Jindal, Meenakshi, Priya Choudhary, and Rajeev K. Sharma. "Analysis of drug promotional literature and its abidance to WHO guidelines." International Journal of Basic & Clinical Pharmacology 8, no. 11 (October 22, 2019): 2502. http://dx.doi.org/10.18203/2319-2003.ijbcp20194792.
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Background: Drug promotional literature (DPL) is used by the pharmaceutical companies for promotion of their drug. It is the commonest source for providing information about the drug to the physician. According to WHO promotional literature should be reliable, truthful, informative, balanced and up to date.Methods: Study was conducted in Department of Pharmacology, Muzaffarnagar Medical College. 200 drug promotional literatures like advertisements published in medical journal, package insert of medicinal products and brochures were collected and analysed according to WHO criteria.Results: Total 200 promotional literatures were analysed. 100 promotional literatures were from the medical journal, 50 were package inserts of medicinal products and 50 were medicinal brochures. On assessing DPL using WHO criteria, all DPL mentioned brand names and dosage form (100%). Most of them published the generic name (98.5%), therapeutic uses (78%), side- effects (75%), dosage regimen (70%), contraindication (62.5%), warnings (55%), drug interaction (54%), precaution (50%), reference to scientific literature (45%), name of manufacture and distributor (99%), address of manufacturer and distributor (50%). Out of 200 DPL only 151 DPL contain references to scientific literature, 88 DPL references were retrievable and 63 were non retrievable.Conclusions: Our study shows although pharmaceutical companies are trying to adhere to the WHO criteria it is not fulfilled. As DPL are an important source of seeking information by the medical practitioner who rely on them to impart treatment to the patient, strict steps to regulate fulfilment of the WHO criteria should be taken by the government and authorities.
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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.
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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.
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Kogan, Lawrence A. "The U.S. Biologics Price Competition and Innovation Act of 2009 Triggers Public Debates, Regulatory/Policy Risks, and International Trade Concerns." Global Trade and Customs Journal 6, Issue 11/12 (November 1, 2011): 513–38. http://dx.doi.org/10.54648/gtcj2011065.
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On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 ('BPCIA') to create an abbreviated approval pathway for generic 'biological products' that are demonstrated to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. The BPCIA is intended to reap cost savings for patients by creating a means for the production, use and sale of follow-on biologic therapeutics in the United States. The BPCIA's intellectual property provisions are modeled in part, after the Drug Price Competition and Patent Term Restoration Act of 1984 (i.e., the 'Hatch-Waxman' Act) pursuant to which generic versions of branded drugs, namely, chemically synthesized small-molecule products, have been approved by permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. Like the Hatch-Waxman Act, the BPCIA provides for the establishment of a form of proprietary rights that are distinct from patent rights, sometimes termed 'data exclusivity' or 'data protection', that consist of a period of time during which the USFDA affords an approved drug protection from competing applications for marketing approval and restricts generic competitors' ability to reference the data generated by the manufacturers of brand-name drugs. Important technical differences, nevertheless, exist between traditional pharmaceuticals and biologic drugs that significantly drive up research and development, regulatory market authorization and product marketing costs. To recoup these greater expenditures, the BPCIA has provided correspondingly longer periods of marketing/data exclusivities to original biologic drugs - generally twelve years instead of five years under Hatch-Waxman - to protect clinical testing data and other proprietary and confidential (trade secret) information generated by an original brand-name drug developer to obtain a biologic license. The BPCIA's longer twelve-year exclusivity period, however, has continued to generate considerable post-enactment debate among healthcare activists, academicians, brand name and generic pharmaceutical manufacturers, and U.S. congressional representatives, which compromises U.S. bilateral and regional trade relations, and potentially impairs the competitiveness of the U.S. biopharmaceutical industry and the economic value of such companies' IP assets. Until recently, public opposition to the BPCIA's twelve-year exclusivity period and patent provisions had frustrated Obama administration efforts to both secure congressional ratification of the previously signed and modified bilateral Korea-U.S. Free Trade Agreement and to successfully advance a favorable U.S. negotiating position that guarantees strong patent and marketing/data exclusivity protections at recent Trans-Pacific Partnership Agreement negotiating sessions.
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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.
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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.
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Vyas, Noopur, and Savita Shahani. "Analysis of drug promotional literatures in a tertiary care hospital: a cross sectional study." International Journal of Basic & Clinical Pharmacology 8, no. 5 (April 23, 2019): 1102. http://dx.doi.org/10.18203/2319-2003.ijbcp20191608.
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Background: Large numbers of new drugs are introduced into the market every day and pharmaceutical companies are in the business of development and selling of new drug. There are different modes of drug promotion which include visual aids, leave behind leaflets and audio visuals. Drug Promotional Literatures (DPL’s) claim to provide vital and accurate information regarding the drug. To ensure rational use of drugs a set of standards laid by the WHO for ethical drug promotion.Methods: A cross sectional observational study was performed in Department of Pharmacology at a tertiary care teaching hospital of Navi Mumbai. A total of 100 drug promotional literatures were randomly collected from different outpatient departments and were evaluated by using WHO guidelines.Results: None of drug promotional literature fulfilled all WHO criteria. Generic name, Brand name, active ingredients were mentioned in all. The problem causing ingredient was not mentioned in any of the cases. Safety information was not complete, adverse drug reactions were mentioned in only 45% of the cases, contraindications and drug interactions were mentioned in 39% of the cases. Manufacturer details including name and address of manufacturer was mentioned in 67% of the DPL’s. References were mentioned in 80% of the literature out of which 84% were from journal articles.Conclusions: None of the DPL’s satisfied all the WHO criteria. Incomplete information may lead to irrational prescription of drugs. Therefore, more strict regulations need to be implemented and physicians must critically evaluate DPL’s before considering the same for prescribing.
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Masuda, Sachiko. "The trend in patent infringement litigation against generic drugs or biosimilars in Japan." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 15, no. 1 (January 30, 2019): 10–17. http://dx.doi.org/10.1177/1741134319826338.
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The timing of market entry for generic drugs or biosimilars based on patent expiration is not always clear for producers of generic drugs and biosimilars or brand-name drug companies, because of an uncertainty due to patent infringement, the market environment, and legislation. In Japan, the policy of promoting the use of generic drugs began in the early 2000s, and the government’s target for generic drug use rate is 80% by 2020. In addition to this drastic change in the market environment, changes in legislation have complicated the timing of market entry for generic drugs and biosimilars. Although there is a relatively low number of patent infringement lawsuits filed against producers of generic drugs and biosimilars each year, emerging litigation issues are likely influenced by recent changes in the market environment and legislation. This article provides an overview of recent legislative changes, analyzes the trends in patent infringement litigation, and discusses litigation issues related to the stable supply of generic drugs and biosimilars in Japan. In light of the emerging issues in this field, producers of generic drugs and biosimilars will require more diligence to avoid patent infringement, and institutional reforms are suggested to reduce an increase in patent infringement litigation.
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Sultana, Anwara, Chandona Sorcar, and Mallika Karmaker. "Evaluation of Adherence of Drug Promotional Literatures (DPLs) to World Health Organization Guidelines." Faridpur Medical College Journal 9, no. 2 (November 12, 2015): 88–91. http://dx.doi.org/10.3329/fmcj.v9i2.25682.
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There is limited mechanism to monitor the drug promotional campaign by pharmaceutical industries despite the fact that there is enough evidence of irrational pharmacotherapy increasingly encountered even in the developed countries. Unethical pharmaceutical promotional practice is a common cause of irrational pharmacotherapy which is a most common problem worldwide. Main objective of this study was to evaluate the medicinal promotional literatures provided by the pharmaceutical companies for accuracy, consistency and validity of the information presented in it, using World Health Organization (WHO) criteria for ethical medicinal drug promotion. Two hundred & fifty (n=250) literatures were collected randomly from selected doctors chambers in Barisal, Bangladesh. One hundred & thirty (130) of those literatures were excluded for being either duplicates, reminder literatures, promoting medical devices or cosmetics. The remaining (120) literatures were then screened to match their macro-informational contents against same advised in world health organization ethical criteria for medicinal drug promotion. The name of active constituent(s), content of active ingredient(s) per dosage form & brand name, were mentioned in 100% (n = 120) of promotional literatures, whereas dosage form were mentioned in 91.66% (n = 110), therapeutic indications were mentioned in 99.1% (n = 119) of literatures but informations on side effects mentioned in only 55.33% (n = 70), contraindications in 63.33 % (n = 76), precautions in 51.67% (n = 62) & references in 70 % (n = 84) of drug promotional literatures (DPLs). None of them mention anything about adjuvant. None of the promotional literatures fulfilled all the WHO criteria. Screened literatures were found to display poorly reliable and unbalanced medication information. Healthcare providers shall, accordingly, seek independent medicinal information sources, and not solely depend on commercial sources of medicinal information. Official regulators shall strictly define and mandate medication information contents in printed pharmaceutical promotional materials. Healthcare providers should, also, master the skills of appraising such promotional printed materials if rational medication use is to be achieved. Pharmaceutical industries did not follow the WHO guidelines while promoting their products, thus aiming to satisfying their commercial motive rather than fulfilling the educational aspect of promotion.Faridpur Med. Coll. J. 2014;9(2): 88-91
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Alkadhimi, Akram, Omar T. Dawood, and Mohamed A. Hassali. "Dispensing of antibiotics in community pharmacy in Iraq: a qualitative study." Pharmacy Practice 18, no. 4 (December 12, 2020): 2095. http://dx.doi.org/10.18549/pharmpract.2020.4.2095.
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Objective: This study aimed to understand the dispensing practice of antibiotics in community pharmacy in Iraq, in addition to explore the community pharmacists' perception about dispensing antibiotics without prescription.
Methods: A qualitative design was conducted on community pharmacists in Baghdad, Iraq. Pharmacists were selected conveniently from different gender, age group, pharmacy type and years of experience. Face-to-face semi-structure interview was used with all the pharmacists to get in-depth understanding about their dispensing practice of antibiotics without prescription in community pharmacy. The data was coded and classified for thematic analysis.
Results: This study found that dispensing of antibiotics without prescription was a common practice in community pharmacy. Pharmacists' perception towards dispensing antibiotics without prescription was associated with the medical condition, safety and efficacy of antibiotics, patients request antibiotics by name, emergency cases, regular customer, promotions from pharmaceutical companies, saving time and cost, brand medications, and poor healthcare services. In addition, there were inadequate knowledge about antibiotic resistance and lack of awareness about antibiotic stewardship leading to inappropriate dispensing practice.
Conclusions: Community pharmacists have poor perception towards dispensing antibiotics without prescription. Educational interventions about antibiotics use focusing on community pharmacists are needed. This will help to optimize the practice of dispensing of antibiotics in the community. In addition, training programs about antibiotic resistance are important to enhance pharmacists' understanding about antibiotic stewardship.
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Feldman, Robin. "The Price Tag of "Pay-for-Delay"." Science and Technology Law Review 23, no. 1 (March 7, 2022): 1–49. http://dx.doi.org/10.52214/stlr.v23i1.9389.
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In a landmark decision nearly a decade ago, the U.S. Supreme Court opened the door for antitrust suits against brand and generic pharmaceutical companies who engage in collusive settlements to delay the time for the generic to come to market. With these “pay-for-delay” agreements, brand-name companies offer prospective generics some form of compensation in exchange for the generic’s promise not to enter the market until an agreed-upon date. Laying the groundwork for the lawsuit that would eventually lead to the Actavis decision, the Federal Trade Commission (“FTC”) published a study estimating that pay-for-delay agreements cost American consumers $3.5 billion annually, a figure that has been cited repeatedly by scholars and policymakers alike.
To understand the state of pay-for-delay agreements, this Article presents an in-depth examination of the burden that pay-for-delay imposes, both on society at large and on individual patients, and explores the modern legal landscape that has emerged since the Supreme Court’s historic pronouncement. Part I describes pay- for-delay agreements, exploring the literature on the potential harm of such agreements among pharmaceutical competitors. Part II presents a new analysis demonstrating that the cost of pay-for-delay to American consumers is far greater than anyone has recognized, and well beyond the $3.5 billion figure cited by the FTC in 2010. We applied six different methodologies to provide as fair and broad a view as possible. The range of methodologies show that at a minimum, the cost of pay-for-delay settlements on the U.S. population between 2006 and 2017 is $6.2 billion per year—almost double that of the FTC’s estimate. The methodology with the largest result suggests that the cost could be as high as $37.1 billion per year— ten times higher. Part III argues that courts are allowing this costly problem to flourish unchecked. This part reviews pay-for-delay decisions since Actavis, arguing that the courts have failed to properly analyze such cases from the perspective of all three notions inherent in the words “pay,” “for,” and “delay.” Finally, Part IV offers a path forward through the doctrinal haze.
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Vojdani, Aristo, Jama Lambert, and Gottfried Kellermann. "The Role of Th17 in Neuroimmune Disorders: A Target for CAM Therapy. Part III." Evidence-Based Complementary and Alternative Medicine 2011 (2011): 1–11. http://dx.doi.org/10.1093/ecam/nep064.
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Abundant research has mapped the inflammatory pathways leading to autoimmunity and neuroinflammatory disorders. The latest T helper to be identified, Th17, through its proinflammatory cytokine IL-17, plays a pathogenic role in many inflammatory conditions. Today, healthcare providers have a wealth of anti-inflammatory agents from which to choose. On one hand, pharmaceutical companies market brand-name drugs direct to the public and physicians. Medical botanical knowledge, on the other hand, has been passed down from generation to generation. The demands for natural healing therapies have brought corresponding clinical and laboratory research studies to elucidate the medicinal properties of alternative practices. With a variety of options, it can be difficult to pinpoint the proper anti-inflammatory agent for each case presented. In this review, the authors highlight a vast array of anti-inflammatory medicaments ranging from drugs to vitamins and from botanicals to innate molecules. This compilation may serve as a guide for complimentary and alternative healthcare providers who need to target neuroinflammation driven by Th17 and its inflammatory cytokine IL-17. By understanding the mechanisms of anti-inflammatory agents, CAM practitioners can tailor therapeutic interventions to fit the needs of the patient, thereby providing faster relief from inflammatory complaints.
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Arora, Malika, Manpreet Kaur, Parveen Bansal, and Manish Arora. "ATC/DDD Directed Classification of Neural Ayurvedic Medicines." Current Traditional Medicine 5, no. 2 (September 23, 2019): 147–58. http://dx.doi.org/10.2174/2215083804666181002093557.
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Introduction: People have been using herbs for health care since Vedic times. Due to resurgence of ayurveda, utilization and consumption of herbal medicines is tremendously increasing leading to a significant percentage of the pharmaceutical market. The huge commercial benefits of herbal products are capturing the interest of pharmaceutical companies worldwide. Hence the safety and quality of medicinal plant materials and finished herbal medicinal products have become a major concern for health authorities, pharmaceutical industries as well as to the public. Presently, plenty of clinical trials are being conducted on herbal medicines; however, absence of harmonized classification has led to various confusions. The most important concern is the disputed identity of ayurvedic formulations sold under different brand names in different regions of the country and world. Recently, allopathic medicines have been classified by WHO on the basis of ATC/DDD (Anatomical- Therapeutic-Chemical/Daily Defined Dose) pattern of classification. The absence of such type of classification for ayurvedic products creates a situation of non recognition of these products in the international market. Hence there is a need to develop a classification system that is on the lines of ATC/DDD so that particular herb may qualify a product to be recognised under one name all over the world. Materials and Methods: Keeping in view the above scenario, a classification system is being proposed for ayurvedic products. The ayurvedic formulations and their site of action have been searched from various Ayurvedic texts. Internet sources such as Pubmed, Google Scholar, JSTOR etc. Results: The major reason for adopting similar classification for herbal medicines is that ayurvedic texts given by various scholars are published in Sanskrit or in the local/regional languages which make it difficult for the researchers to access, understand and interpret the knowledge shared. Conclusion: It is utmost important to generate such classification for herbal medicines as it will generate a classification data which can further be exploited for safety, efficacy as well as quality control purposes. Moreover, innovative classification will be helpful to provide standardized as well as a uniform way to classify the various herbal drugs and to generate new avenues for further ayurvedic research with more degree of precision. The classification will enable a product to be known under one banner/name at international level. Since the market is flooded with formulations related with neural disorders, hence herbal products used in neural disorders have been taken in the first phase.
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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.
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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.
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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.
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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.
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Marcoux, Andrew W. "Information that Brand-Name Companies do not Tell us." Drug Intelligence & Clinical Pharmacy 21, no. 3 (March 1987): 296–97. http://dx.doi.org/10.1177/106002808702100319.
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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.
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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.
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Bakker, Andrea. "Is Brand Name Best? Brand name versus generic pharmaceuticals in clinical practice." University of Ottawa Journal of Medicine 7, no. 1 (June 8, 2017). http://dx.doi.org/10.18192/uojm.v7i1.1438.
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In the last few years some of the biggest ‘blockbuster drugs’, that is the drugs that make pharmaceutical companies billions of dollars, have lost their patents. This means that generic manufacturers are able to produce these medications at a fraction of the cost. But what really differentiates generics from brand name medications? This commentary will explore how differences in licensing affect drug efficacy and how the pharmaceutical landscape in Canada affects patient care. RÉSUMÉ Au cours des dernières années, les brevets de certains des plus grands « médicaments vedettes», c’est-à-dire des médicaments qui rapportent des milliards de dollars aux compagnies pharmaceutiques, sont arrivés à échéance. Cela signifie que les fabricants de médicaments génériques peuvent désormais produire ceux-ci à moindre coût. Mais qu’est-ce qui différencie véritablement les mé- dicaments génériques de ceux d’origine? Ce commentaire examinera comment les différences en ce qui a trait aux licences affectent l’efficacité des médicaments, et comment le panorama pharmaceutique au Canada affecte les soins de santé.
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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.
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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.
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Latwal, Bharti, and Amrish Chandra. "Authorized generics vs. branded generics: A perspective." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, August 3, 2020, 174113432094777. http://dx.doi.org/10.1177/1741134320947773.
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Nowadays, there are many generic medications available in the market. Their sale is increasing day by day due to their lower cost and affordability by most of the customers. Generic medications are pharmaceuticals that are therapeutically equivalent to an original off patent drug. Both authorized generics and branded generics are the versions of generic medications. They offer lucrative business and increase competition for ordinary generics. They supply medications having quality of branded drugs at lower prices and this establishes their recognition among the masses who earlier has limited options to buy only brand-name drugs. They are cheaper than brand name drugs but costlier than ordinary generics. Authorized generics are sold only by Innovator Companies but the branded generics can be sold by both innovator companies and generic companies. They both are different from one another and have their own impact on the brand drug companies, generic companies and consumers.
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Byng, Danalyn. "Trade Agreements and Pharmaceutical Patent Protection: Implications for the Governance over Pharmaceutical Products in Canada." Healthy Dialogue 1, no. 1 (September 4, 2012). http://dx.doi.org/10.25071/1929-8404.34702.
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This paper was prepared for a course on Canadian health policy. Its purpose is to expose the harmful ramifications of international trade agreements on the pharmaceutical market in Canada and the governance surrounding this market. This paper will explore the various implications that trade agreements have on the affordability of drugs, the strength of intellectual property protection, and the transfer of authority and influence from government to “Big Pharma.” This paper will unravel the reality that trade agreements are not beneficial to the Canadian people looking to access an affordable pharmaceutical market, but rather, act quite contrary to this. Facts will show that trade agreements work to put money into the pockets of large brand-name pharmaceutical companies in the forms of billions of dollars of revenue and profit. This paper will encourage readers to question the feasibility of extending patent legislation for brand-name pharmaceutical products, the increasing role of trade agreements and the pharmaceutical industry in Canada, and the substitutability of brand-name drugs over cheaper generic alternatives.
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Bindusha, H. C. "Intellectual Property Rights Issues in Indian Pharmaceutical Industry." Journal of Pharmaceutical Research International, July 28, 2021, 281–86. http://dx.doi.org/10.9734/jpri/2021/v33i38b32124.
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Historically, India has neglected, and even made a farce of, pharmaceutical patents. In fact, it was not until 2005 that India offered patent protections for pharmaceutical companies at all. This has led to abuses of the compulsory licensing agreement with the World Trade Organisation, and has led to major criticisms of other global pharmaceutical companies like Pfizer, Roche, and Bayer. According to these companies, India’s generic drug manufacturing industry is destroying R&D funding and future innovation. This is because the companies which invented the brand name drugs are not receiving royalties; and therefore, losing out on profit, a lot of which would have been put back into R&D. While the World Trade Organisation under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement (Doha Declaration) has provided for the use of compulsory licenses (temporary patent rights for life-saving pharmaceuticals), recently India has been more lenient in its use of this stipulation. In fact, the first use was in 2012 for Nexavar. Since then India has used the compulsory licensing provision at least five times. The total numbers of Indian Pharmaceutical Companies those who are having Research and Development facilities and also having Intellectual Property Rights for the past five years consecutively are take for this study.
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Nardi, Elene Paltrinieri, and Marcos Bosi Ferraz. "Perception of the value of generic drugs in São Paulo, Brazil." Cadernos de Saúde Pública 32, no. 2 (2016). http://dx.doi.org/10.1590/0102-311x00038715.
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Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.
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Hadipour Dehshal, Mahmoud. "Safety and efficacy of drugs: What do I need to know?" Thalassemia Reports 8, no. 1 (April 19, 2018). http://dx.doi.org/10.4081/thal.2018.7494.
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Access to the essential medicines is an important challenge in the developing countries. To have access to the quality and affordable medicines, the pharmaceutical decision makers try different strategies. The production of generic and copy medicines is one of the strategies that if adopted based on the recognized standards and norms can be effective in raising the health status in the developing countries. According to US Food and drug Administration, “a generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version”. To make it more understandable, you can define a generic medicine as an equal substitute for its brand-name if it has been produced based on standard norms. However, shakable regulation impairs the quality of generic and copy medicines and harms the health of consumers. NGOs including advocacy groups and scientific groups play effective and undeniable role to ensure quality of the health services which patients receive. Therefore, building a network between activists and scientists is the first step towards better quality. Since we are living in a global market and pharmaceutical active ingredients of pharmaceutical finished products can be found in different regions in the market, the second step of the battle against substandard is to make an international network between advocacy groups. The international network assists to prevent menaces of substandard medicines faster and with reliance on a scientific approach. Furthermore, in the lecture, we aim to reflect over the role of different beneficiaries including international organizations, governments, and pharmaceutical companies in ensuring the feasible and sustainable access of citizens to the essential medicines.
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Prakash, Gnana. "Perception of rural and urban population on generic and branded drugs." Future Journal of Pharmaceuticals and Health Sciences 1, no. 4 (October 9, 2021). http://dx.doi.org/10.26452/fjphs.v1i4.175.
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Generic medicines are identical/ clone to an innovator or product brand name. After expiration of patent terms of the innovator product, other pharmaceutical companies usually apply to the drug regulatory bodies for approval to market the generic versions of the innovator's drugs. Generic drugs in the market were sold under the non-proprietary name or brand name. Drugs and medicines form a significant portion of out of pocket (OOP) expenses in Indian households. In order to resolve this issue, Government of India launched Jan Aushadhi Scheme (JAS) to provide inexpensive generic drugs to the patients. A separate interview was conducted for the illiterate people and Google forms were forwarded through whatsapp for literates, both contain the same questions to exclude the bias. The collected data was analysed and converted to graphs/ pie charts and the collected data was documented. Our study concludes that by using the questionnaire, the total patients (n= 500) were interviewed, different ages of people were included(15 to above 50).15-30 age group 29.2%, 31-49 age group 39.8%, above 50 age group 31% were involved. Male 60.4%, Female 39.4%, literate 47.4%, illiterate 52.6%, rural 49%, urban 51% were involved. A standard survey form/data collection sheet for both rural and urban population was used. Both literates and illiterates in rural and urban population almost 49% preferred branded drugs due to brand trust, quality, efficacy, and nearly 38% purchase medications based on the availability and remaining 13% preferred generic due to various reasons like cost effectiveness, same as branded quality and effectiveness.
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Carrier, Michael. "Product Hopping." Journal of Commercial Biotechnology 23, no. 2 (August 30, 2017). http://dx.doi.org/10.5912/jcb795.
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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.
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Bhakta, Heran C., Jessica M. Lin, and William H. Grover. "Measuring dissolution profiles of single controlled-release drug pellets." Scientific Reports 10, no. 1 (November 12, 2020). http://dx.doi.org/10.1038/s41598-020-76089-z.
Full textAbstract:
AbstractMany solid-dose oral drug products are engineered to release their active ingredients into the body at a certain rate. Techniques for measuring the dissolution or degradation of a drug product in vitro play a crucial role in predicting how a drug product will perform in vivo. However, existing techniques are often labor-intensive, time-consuming, irreproducible, require specialized analytical equipment, and provide only “snapshots” of drug dissolution every few minutes. These limitations make it difficult for pharmaceutical companies to obtain full dissolution profiles for drug products in a variety of different conditions, as recommended by the US Food and Drug Administration. Additionally, for drug dosage forms containing multiple controlled-release pellets, particles, beads, granules, etc. in a single capsule or tablet, measurements of the dissolution of the entire multi-particle capsule or tablet are incapable of detecting pellet-to-pellet variations in controlled release behavior. In this work, we demonstrate a simple and fully-automated technique for obtaining dissolution profiles from single controlled-release pellets. We accomplished this by inverting the drug dissolution problem: instead of measuring the increase in the concentration of drug compounds in the solution during dissolution (as is commonly done), we monitor the decrease in the buoyant mass of the solid controlled-release pellet as it dissolves. We weigh single controlled-release pellets in fluid using a vibrating tube sensor, a piece of glass tubing bent into a tuning-fork shape and filled with any desired fluid. An electronic circuit keeps the glass tube vibrating at its resonance frequency, which is inversely proportional to the mass of the tube and its contents. When a pellet flows through the tube, the resonance frequency briefly changes by an amount that is inversely proportional to the buoyant mass of the pellet. By passing the pellet back-and-forth through the vibrating tube sensor, we can monitor its mass as it degrades or dissolves, with high temporal resolution (measurements every few seconds) and mass resolution (700 nanogram resolution). As a proof-of-concept, we used this technique to measure the single-pellet dissolution profiles of several commercial controlled-release proton pump inhibitors in simulated stomach and intestinal contents, as well as comparing name-brand and generic formulations of the same drug. In each case, vibrating tube sensor data revealed significantly different dissolution profiles for the different drugs, and in some cases our method also revealed differences between different pellets from the same drug product. By measuring any controlled-release pellets, particles, beads, or granules in any physiologically-relevant environment in a fully-automated fashion, this method can augment and potentially replace current dissolution tests and support product development and quality assurance in the pharmaceutical industry.