Recent years have seen the growing popularity of drugs designed to treat attention deficit hyperactivity disorder (ADHD), and the number of patients, scripts, and revenues has been steadily increasing. By the mid-1990s there were already several branded drugs marketed for this disorder, as well...

Drug review speed has increased substantially in the 1990s, largely due to industry-funded user fees. Following several drug withdrawals, however, new questions have emerged about the effects of this change on drug safety. This article examines the impact of review speed and user fees on counts...

This report offers the first comprehensive analysis of FDA approvable actions. During 1998 through 2005, 87 NME drug-product NDAs (NME-NDAs) received at least one approvable action by CDER prior to final approval. The proportion of NME-NDAs receiving at least one approvable action increased from...

The COVID pandemic has underscored that IP can limit the ability to addressing public health crises because IP owners have the legal right to bar others from making needed supplies. However, what is less well understood yet critical to making medical treatments available are IP-related barriers...

This paper analyzes a maximum price system and a reference price system in a vertical differentiation model with a brand-name drug and a generic. In particular, both instruments are compared with respect to their performance in reducing public expenditure, limiting financial exposure of...

This paper evaluates the effect on competition of adopting the FTC's product hopping theory as an antitrust doctrine. The paper criticizes the theory and explains why it would be a mistake to adopt it as a guide to antitrust liability

This paper analyzes a maximum price system and a reference price system in a vertical differentiation model with a brand-name drug and a generic. In particular, both instruments are compared with respect to their performance in reducing public expenditure, limiting financial exposure 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...

The year 2005 marks the end of transition period for many developing countries with competent pharmaceutical sectors that competed in supplying generic versions of patented drugs to LDCs before, thereby inducing price competition and enhancing access to medicines. In a post-2005 scenario, the...

The year 2005 marks the end of transition period for many developing countries with competent pharmaceutical sectors that competed in supplying generic versions of patented drugs to LDCs before, thereby inducing price competition and enhancing access to medicines. In a post-2005 scenario, the...