Drug Brand Switching: A Regulatory Perspective

The replacement of expensive medications marketed by companies that bore the cost of development and testing, by low-cost "generics" once patent protection ends, is a common step in the life cycle of most drugs. Although generics are required to meet strict bioequivalence standards, the introduction of first-time and subsequent generics may lead to unease and increased reports of adverse effects or therapeutic failure. An established causal relationship between these effects and the switch from innovator to generic products can be challenging to assess. With the ongoing debate, this paper primarily explores how the regulatory framework governing generic drug approval may have contributed to this medical conundrum. In addition, we also offer a perspective on the potential role of pharmacogenetics within this setting.