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This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

This chapter analyzes the tourism industry from national and regional perspectives, in order to understand the past and current trends in Costa Rica’s positioning and branding attributes and strategies for tourism development. The intent here is not to provide an exhaustive comprehensive literature review of academic research on country branding; and so it is by all means a case study as it describes the evolution of the tourism industry in Costa Rica – including the transformative stages the country went through since the 1980s – as planned tourism national management programs evolved toward reaching the target of creating a nature-based tourism brand. The medical industry and then medical tourism industries are analyzed in a global basis and the US market is examined in detail because of its potential to develop a new complementary niche for Costa Rica’s tourism industry. The chapter intends to asses Costa Rica’s potential to become a country brand in medical tourism, leveraged on its natural tourism destination branding status quo.

Customers today expect businesses to cater to their individual needs by tailoring the products they purchase to their own preferences. The term “Industry 5.0” refers to a new wave of manufacturing that aims to meet each customer's unique demands. Even while Industry 4.0 allowed for mass customization, that wasn't good enough before, customers today demand individualized products at scale, and Industry 5.0 is driving the transition from mass customization to mass personalization to meet these demands. It caters to the individual needs of each consumer by meeting their demands. More specialized components for use in medicine are made possible by the widespread customization made possible by Industry 5.0. These individualized parts are included into the medical care of the patient to meet their specific needs and preferences. In the current medical revolution, an enabling technology of Industry 5.0 can produce medical implants, artificial organs, bodily fluids, and transplants with pinpoint accuracy. With the advent of AI-enabled sensors, we now live in a world where data can be swiftly analyzed. Machines may be programmed to make complex choices on the fly. In the medical field, these innovations allow for exact measurement and monitoring of human body variables according to the individual's needs. They aid in monitoring the body's response to training for peak performance. It allows for the digital dissemination of accurate healthcare data networks. In order to collect and exchange relevant patient data, every equipment is online.

Using the pharmaceutical sector as a microcosm of the health sector, we highlight the most prevalent structural and policy issues that make this sector susceptible to corruption and ways in which these vulnerabilities can be addressed. We conducted a literature review of publications from 2004 to 2015 that included books, peer-reviewed literature, as well as gray literature such as working papers, reports published by international organizations and donor agencies, and newspaper articles discussing this topic. We found that vulnerabilities to corruption in the pharmaceutical sector occur due to a lack of good governance, accountability, transparency, and proper oversight in each of the decision points of the pharmaceutical supply chain. What works best to limit corruption is context specific and linked to the complexity of the sector. At a global level, tackling corruption involves hard and soft international laws and the creation of international standards and guidelines for national governments and the pharmaceutical industry. At a national level, including civil society in decision-making and monitoring is also often cited as a positive mechanism against corruption. Anticorruption measures tend to be specific to the particular “site” of the pharmaceutical system and include improving institutional checks and balances like stronger and better implemented regulations and better oversight and protection for “whistle blowers,” financial incentives to refrain from engaging in corrupt behavior, and increasing the use of technology in processes to minimize human discretion. This chapter was adapted from a discussion piece published by Transparency International UK entitled Corruption in the Pharmaceutical Sector: Diagnosing the Challenges.

To present the view that harm arising from aggressive marketing and sales of health-related products and services (including dangerous and defective ones) in order to maximize profits should be a cause of concern for public health academics and practitioners.

The discussion is conducted using biomedical ethics principles and supported using various real-world examples.

Harm arising from aggressive marketing and sales of health-related products and services (including dangerous and defective ones) in order to maximize profits should be a cause of concern for public health academics and practitioners. In the area of products, the most obvious would be tobacco products. In the case of pharmaceutical drugs, it would include overuse or inappropriate use because of aggressive marketing. It would also include harm caused by the continued promotion and sale of a drug in the face of evidence that it has significant negative side effects. Brody and Light’s “Inverse Benefit Law,” that is, the benefit-to-harm ratio of drugs tends to vary inversely with how aggressively drugs are marketed is discussed. Harm is also evident in health-related services, for example, misuse of ultrasonography for sex-selective abortion. This chapter will discuss how the risk of harm is increased because of questionable marketing strategies used by drug companies.

One limitation is that no attempt to quantify the harm done (e.g., through economic evaluation techniques) is carried out.

This chapter presents the view that much more attention should be paid to this aspect of medicalization as a public health threat.

In Chapter 10 in this volume, Comandé (2009) has proposed that American courts adapt “scheduling” for use by juries in awarding nonpecuniary damages in personal injury and wrongful death cases. Comandé suggests that American courts can develop schedules for awarding damages for nonpecuniary losses on the basis of the severity of the injury and the age of the injured party, based on data on prior awards by particular courts in specific jurisdictions. Comandé's proposal is shaped by the experiences of European jurisdictions that have developed scheduling for awarding nonpecuniary damages.

This chapter argues that neoliberal governmentality in immunization relocates the Turkish state's position regarding vaccine and immunization policies. Neoliberalism is often discussed in the context of privatization, performance, and effectiveness separately. However, more attention should be paid to the set of strategies that are employed in public policy processes to manage populations in terms of immunization, while intertwining power with knowledge. Following Foucault's concept of governmentality and taking it further within the context of biopolitics, this chapter focuses on different knowledge practices regarding vaccine and immunization policies in Turkey. In doing so, this case study applies a post-structural analysis to examine vaccine production, vaccine know-how, and immunization policies inscribed in policy documents as a form of knowledge practice. The analysis sheds light on the reflexive transformation of the concept of biopolitics, which is moving from state-oriented knowledge practices toward a neoliberal governmentality of immunization.

Purpose – The marketing literature does not provide a satisfactory explanation for the role of consumer's attention in the process of how Country-of-Manufacture (COM) information influences consumer product evaluations. The research contributes to an improved understanding of this process by integrating the construct of “attention to Country-of-Manufacture” into the model and examining its relationship with the influence of COM.

Design/methodology/approach – Survey data are collected from American consumers aged 18 years and above. To test the research hypotheses, MANOVA and canonical correlation analysis are performed in analyzing the data.

Findings – COM has more influence on the attentive group (consumers consciously paying attention to the COM information on a product label), on their evaluations of abstract product attributes such as durability and reliability than it does on the inattentive group (consumers not paying conscious attention to such information). In contrast, COM's influences on evaluating concrete product attributes such as style, model, availability, and quality are all significantly related to involvement with COM, but not to attention.

Research limitations/implications – The product assessments sought from respondents are generally on “foreign” products. Future research needs to obtain product-specific evaluations within each product category in testing the model and see how the results may differ or not differ across product categories.

Practical implications – Marketers selling products with high performance in abstract attributes such as durability and reliability should increase consumers’ attention to the COM through effective product labeling.

Originality/value – This research identifies and empirically investigates the difference of COM effects on consumers’ product judgment between consumers who are attentive and the ones who are inattentive to COM information.