The Food and Drug Administration currently does not monitor drug prices. As FDA leaders note, the agency's responsibility is for drug safety and efficacy, and besides they do not want to become embroiled in drug pricing controversies. However, monitoring drug pricing can be useful beyond any...

The Prescription Drug User Fee Act (PDUFA) created rewards for the Food and Drug Administration (FDA) if it can meet goals related to the duration of the 'formal review stage' of the drug development process. Later, the Medical Device User Fee and Modernization Act (MDUFMA) set up a similar...

Policy reforms in the Food and Drug Administration (FDA) have led to substantial increases in the speed of new-drug review. While data show that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety...

In this paper, we ask whether courts should continue to rule settlements in the context of pharmaceutical claims per se legal, when these settlements comprise payments from originator to generic companies, potentially delaying generic entry compared to the underlying litigation. Within a...

Using individual level-data, the paper uncovers patient and drug characteristics that determine the probability of using the original patented products despite the presence of generic substitutes in the Czech Republic in the period 2009-2013. Our results reveal different behavioral patterns for...

This paper examines competition between generic and brand-name drugs in the regulated Spanish pharmaceutical market. A nested logit demand model is specified for the three most consumed therapeutic subgroups in Spain: statins (anticholesterol), selective serotonin reuptake inhibitors...

I evaluate how the probability of substitution of a prescribed drug in a pharmacy depends on the pharmacists' profits and patients' out of pocket costs. I use Finnish population-wide data covering all prescriptions of three popular antidepressants. I find that one euro increase in the total...

Markets require informed participants to function efficiently. This paper examines the impact of providing targeted information directly to patients on their purchasing-decisions regarding pharmaceutical drugs. We analyze the effect of informational letters sent by a Swiss health insurer to...

I examine physician agency in healthcare services in the context of the choice between brand-name and generic pharmaceuticals. I examine micro-panel data from Japan, where physicians can legally make profits by prescribing and dispensing drugs. The results indicate that physicians often fail to...

On innovation grounds, pharmaceutical patents are unnecessary in low income populations, since such markets cannot do much to support global pharmaceutical profits. The public health needs of low income populations require patented drugs to be manufactured at the marginal cost of production,...