In August of 1997, the Food and Drug Administration (FDA) set new less restrictive guidelines for direct-to-consumer (DTC) advertisements by pharmaceutical companies. I examine the common stock price reaction of pharmaceutical companies following the announcement of new FDA guidelines on...

Today, the global pharmaceutical product value chain is becoming increasingly complex and this has led to the emergence of 'multiple quality standards' for medicines. But this non-uniformity in the quality of medicine is also contingent upon both the regulatory milieu in the country of...

Die Bundesregierung und die Europäische Kommission mussten in den letzten Wochen viel Kritik bezüglich ihrer Impfstoffbeschaffungsstrategie zur Eindämmung der Corona-Pandemie einstecken. Vor dem Hintergrund zu schleppend erscheinender Impfstofflieferungen und der zunehmenden Gefahr durch die...

This chapter describes the market for pharmaceuticals, which exceeded $500 million in sales in 2010. The industry is also characterized by extensive regulation of almost every activity, from product development through manufacturing and marketing, which we summarize. We next describe the...

This paper studies oligopolistic competition in off-patent pharmaceutical markets using a vertical product differentiation model. This model can explain the observation that countries with stronger regulations have smaller generic market shares. It can also explain the differences in observed...

This paper analyzes a maximum price system and a reference price system in a vertical differentiation model with a brand-name drug and a generic. In particular, both instruments are compared with respect to their performance in reducing public expenditure, limiting financial exposure of...

This paper analyzes a maximum price system and a reference price system in a vertical differentiation model with a brand-name drug and a generic. In particular, both instruments are compared with respect to their performance in reducing public expenditure, limiting financial exposure of...

This article examines the implications of U.S. federal and international regulatory mandates in the construction and circulation of racial categories in biomedical research and drug development. It will focus on the interface between two regulatory mandates in particular: the International...

In this paper we highlight the benefits of increased competition through reform of rules and regulations that may hinder competition and innovation. The paper discusses details from several papers that shed light on the nature of rules and regulations in various markets such as innovation,...

This paper analyzes the relationship between postmarketing promotional activity and reporting of adverse drug reactions (ADRs) by modeling the interaction between a regulator (the FDA) and a pharmaceutical firm. Promotion-driven market expansions enhance profitability yet may involve the risk of...