Before it can sell a prescription drug lawfully in interstate commerce, a manufacturer must prove to the satisfaction of the Food and Drug Administration that the drug is both safe and effective. Congress approved this requirement in 1962 unanimously. Four decades of changes in the drug market...

Governments worldwide are increasingly concerned about the booming CBD (cannabidiol) products. However, little is known about the impact of their liberalization. We study a unique case of unintended liberalization of a CBD-based product (light cannabis) that occurred in Italy in 2017. Using...

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...

Governments and firms often use committees of experts to help them make complexdecisions, but conflicts of interest could bias experts' recommendations. We focus on whetherfinancial ties to drug companies bias FDA drug advisory committee (AC) members' voting ondrug approval recommendations. We...

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...

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food...

This paper examines the optimal content regulation of DTCA by comparing two forms of DTCA-product-specific and category-specific-and identifies a key tradeoff which underlies this policy debate. Our analysis suggests that the optimal form of DTCA depends crucially on the cost effectiveness of...

The debate on whether COVID-19 vaccine patents are slowing down the pace of vaccination and the recovery from the crisis has brought the optimal design of pharmaceutical patent policy to the fore. In this paper we evaluate patent policy in the US pharmaceutical industry. We estimate the effect...