Academic literature on the topic 'Brand-name pharmaceutical companies'

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

碩士
國立交通大學
科技法律研究所
102
Pharmaceutical industry is a complex business. While it is without a doubt that researching new drug is a capital-intensive and risky business; however, no all drug makers are engaged in this perilous endeavor. Broadly speaking, generic drug maker is an exception of this trend. By definition, pioneer drug maker, also known as brand name company, are referring to drug maker whose primary mode of business is engaging in researching new drugs; on the other side of the spectrum, is generic drug maker. Generic drug maker are pharmaceutical company that primarily engaged in manufacturing of known drugs whose patent term already expired. From public policy’s perspective, both types of company are useful. Brand name company provides new pharmaceutical innovation and improvement; while generic company facilitates accessibility and provides more economically friendly drug to general public and healthcare provider alike. This conflicting interest will be the main theme throughout this paper and how brand name and generic company use litigation, especially asserting patent right, to further each their own interests i.e. Brand name will want to delay the entrance of generic drug into the market for as long as possible; in contrast, generic drug maker will want to market its drug as soon as possible. This paper will begin by providing an introduction on the history of pharmaceutical industry and its unique characteristics that distinguish this industry from other business. Followed by an introduction on U.S. drug market and some of U.S.’s earlier attempt to control the conflicting interests between brand name and generic drug maker, this paper will start in earnest by providing a critical analysis on Hatch-Waxman Act and patent linkage system that comes with it. The author will comment on some of act’s success and failure and how it opens an era of wild litigation battles between brand name and generic companies. Following Hatch-Waxman Act is another revolutionary piece of legislation known as “Medicare Prescription Drug, Improvement, and Modernization Act” which is American’s attempt to fix problems and abuse created or afforded by Hatch-Waxman Act. As will discuss in detail in this paper, while Medical Moderation Act did successful in eliminating some of the problems that have plagued Hatch-Wax Act for decades, some of its problem remain unresolved and some of act’s half measure inadvertently opens door for more abuses. However, U.S. is certainly not the only country in the world that had become battleground for pharmaceutical companies. This paper will provide a comparison of different regulatory regime implemented by Australia, Canada and Korea to combat these problems. In the latter part of this paper will present some of uniquely Taiwan element that will play a significant role in re-balance the interests. Finally, though Taiwan have yet to fully adopt the American system in controlling drug marketing process, many of the multinational brand name company have already tried their legal tactic used in States in Taiwan’s court. Hopefully, this paper will provide some observation to Taiwan’s court and legislators when or if Taiwan decides to fully implement American system.

This chapter traces the shift in the pharmaceutical markets in Kenya, Tanzania, and Uganda from markets dominated by originator (brand-name) drugs produced by western companies to markets dominated by generic drugs produced in the global South, most prominently, in India. The rise of Indian exports was not simply a consequence of conditions in India, as it is often suggested. In East Africa, it was also a consequence of market liberalization imposed through Structural Adjustment Programs (SAPs) on the three countries in the 1980s and 1990s. Specifically, the removal of foreign exchange restrictions—combined with inadequate regulation of the pharmaceutical market—allowed an unmonitored entry of drugs into the private market. The chapter then describes the ongoing efforts by multinational pharmaceutical companies to slow down that shift—especially by strengthening intellectual property rights. It also examines why reports on the prevalence of Chinese drugs in East Africa are greatly exaggerated.