Pharmaceutical antitrust law is hard. When drug companies delay generic entry, is that beneficial “life-cycle management”? Or is it unjustified anti-competitive behavior? The question arises in multiple settings, including patent settlements by which brand firms pay generics to delay...

Prescription drugs are much in the news these days. There are two topics which appear very often; first, the very high prices of new drugs, particularly the “specialty” drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for...

This paper explores Japan’s role in reshaping the global pharmaceutical intellectual property regime by examining its position on the expansion of intellectual property rights (IPR) in negotiations for two regional trade agreements: the Trans Pacific Partnership Agreement (TPP) and the...

External reference pricing (ERP), the practice of benchmarking domestic drug prices to foreign prices, generates an incentive for firms to withhold products from low-income countries. Using a novel moment inequality approach, we estimate a structural model to measure the extent to which ERP...

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that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety...

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...

This study investigates how enhanced regulation can promote innovation, focusing on the impacts of a significant regulatory reform in China's pharmaceutical sector implemented in 2015. Inspired by regulatory practices in the U.S., the reform aimed to address application backlogs and reduce...