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This investigation set out to uncover whether CSR appeals – socially and/or environmentally oriented efforts promoted as part of a corporation’s advertising campaign – present a fruitful strategy for pharmaceutical manufacturers. This study investigates whether consumers in the two countries are similar with regards to (1) attitudes toward CSR engagement (2) perception of the social engagement of a company (3) perceived product/cause fit and (4) evaluation of CSR versus non-CSR appeals in OTC pharma ads. A field study was conducted (483 subjects; non-student sample) to explore how a standardized promotional message with or without a CSR appeal is perceived in a cross-cultural setting. Results indicate that consumers’ response (with regard to attitudes toward CSR, perceived social engagement by a company, perceived product-cause fit, as well as ad evaluation) all varied by country. Consumer responses were only tested with regard to a fictitious product as well as for one product category. Overall results suggest that CSR messages resonated more with some consumers than with others and, thus, may need to be tailored by market. Apart from a very small number of investigations, neither consumer evaluations of over-the-counter (OTC) drug ads in general, nor responses to CSR ad appeals in particular, have been explored. Thus, this investigation’s primary goal is to explore responses toward CSR messages in non-prescription drug ads in the United States and Brazil.

The purpose of this investigation is to add to the body of knowledge regarding consumer skepticism toward advertising in general, and toward pharmaceutical advertising in particular. The study was conducted in the U.S. and in Germany. Skepticism toward advertising for both prescription and non-prescription pharmaceuticals was analyzed. Additional variables explored include: health consciousness, product involvement with pharmaceuticals, satisfaction with information in pharmaceutical advertising, and the importance of pharmaceutical advertising as a source of information. Furthermore, differences in the cultural value of uncertainty avoidance between U.S. and German consumers were examined and related to skepticism toward pharmaceutical advertising. Three hundred and forty-one Americans and 447 Germans were surveyed. A significant finding of this research revealed that skepticism toward pharmaceutical advertising is lower than skepticism toward advertising in general. Results also indicated that consumers showed no difference in their level of skepticism toward advertising for prescription versus non-prescription drugs. This is a particularly relevant finding as it relates directly to the ongoing discussion in Europe regarding whether or not to lift the ban on advertising for prescription drugs. Skepticism toward pharmaceutical advertising was found to be significantly negatively related to involvement with pharmaceuticals, to satisfaction with the informational content of the advertisements, to satisfaction with the comprehensibility of the advertisements, and to the importance placed on advertising as a source of health information. Regarding cultural differences, U.S. consumers appear to be less skeptical toward advertising in general, and toward advertising for prescription and non-prescription drugs in particular, than German consumers. This may be due to the lower degree of uncertainty avoidance in the U.S. Differences between the two countries related to the additional variables examined in the study are addressed as well. Implications for consumer protection policies are discussed, and recommendations for advertisers of pharmaceutical products are provided. The authors provide a cultural explanation for differences in the degree of skepticism between U.S. and German audiences.

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.

Several high-profile prescription drugs have been withdrawn from the U.S. market in the last decade, yet there is no direct evidence of how a prescription drug withdrawal affects consumers’ use of remaining drugs within the same therapeutic class. In theory, remaining drugs in the therapeutic class could enjoy competitive benefits or suffer negative spillovers from the withdrawal of a competing drug. Using the Medical Expenditure Panel Survey, we test for spillovers following prescription drug withdrawals in six therapeutic classes between 1997 and 2001. Results vary, but we find stronger evidence of negative spillovers than competitive benefits. We conclude with a discussion of the characteristics of drugs and classes that may influence how remaining drugs are affected by a withdrawal in the class.

Since 1973, the pharmacy operations division of the Kaiser Permanente Medical Care Program (KPMCP) has used long-term action research programs as the principal method for orchestrating change. This chapter covers the evolution of action research theory within large, complex organizations, with particular attention to health care organizations. Four case examples from KPMCP are discussed in depth and mapped to the recently advanced Roth model of insider action research. This model considers external and internal business context, the perceived need to create new organizational capabilities, as well as insider action research theory and learning mechanisms used in change programs. Issues posed by the Roth model are explored, and new theory is advanced regarding the need for a long-term perspective, the advantages and difficulties posed when managers act as insider action researchers, and the quality of data gathering that takes place during insider action research change programs.

The Supreme Court’s decision in Federal Trade Commission v. Actavis, Inc. is a challenge to conventional antitrust analysis. Conventional civil antitrust cases are decided by a preponderance of the evidence. This means that conduct challenged under the rule of reason is only condemned if the conduct resulted in more competitive harm in the actual world than a world without the alleged violation. Under conventional analysis, the intent of the parties also plays only a supporting role in determining whether the conduct was anticompetitive. A holder of a valid patent has a right to exclude others practicing the patented technology. And, the patent holder is not assumed to have market power because it expended resources in maintaining exclusionary rights. Actavis creates doubts about these propositions in circumstances beyond the “reverse” payment settlement of a patent suit that may have delayed an alleged infringer market entry. This chapter explores whether applying Actavis logic to antitrust litigation can result in condemnation of practices where there is little chance of an anticompetitive effect, where the patent holder likely has a valid and infringed patent, where there is little reason to believe that the patent holder has market power, and where only one party, or no parties, to an agreement have an anticompetitive intent. This chapter also investigates whether Actavis creates new problems with standing analysis, damages calculations, and the balancing of efficiencies against anticompetitive effects. Nevertheless, the lower courts have begun to extend the logic of Actavis. This is apparent in the condemnation of no-Authorized-generic settlements.