The United States has recently — and belatedly — come to recognize opioid addiction as a public health crisis. What has gone mostly unrecognized is the degree to which this crisis is intertwined with U.S. intellectual property law and related elements of U.S. innovation policy. Innovation...

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature 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...

COVID-19 has led to large numbers of deaths, harms, and financial costs. Without an effective vaccine, those will continue. The pressure to find a vaccine is high; and that pressure creates a risk that the safeguards in place to assure that vaccines are safe and effective will be ignored. The...

This chapter provides a broader view of the development of international laws impacting the protection of drugs from the lens of patents as either a privilege or a right. In particular, this chapter demonstrates how domestic and international laws and policies impacting access to medicine is a...

We show how characterizing optimal patent policy for the pharmaceutical industry only requires information about generic producers' responses to changes in the effective duration and scope of new drug patents. To estimate these responses, we use data on Paragraph IV patent challenges, and two...

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...

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...

Coronavirus Disease 2019 (COVID-19) vaccinations play a main role in the immunization campaign of nations but countries, after a certain share of people vaccinated have to cope with vaccine hesitancy and resistance in population. The goal of this study here is the detection of the max share 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...