Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended the provision substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 180-day exclusivity was to provide an incentive for generic drug applicants to challenge inn...

Choice blindness is the experimental finding that people may miss changes to the outcome of their actions. This effect has been demonstrated in decision tasks concerning attractiveness of faces, as well as smell and taste of different consumer products. But so far, choice blindness experiments have only been done in the “physical” world, using real objects like photographs. Here we extend this ...

In these studies, we examined how a default assumption about word meaning, the mutual exclusivity assumption and an intentional cue, gaze direction, interacted to guide 24-month-olds' object-word mappings. In Expt 1, when the experimenter's gaze was consistent with the mutual exclusivity assumption, novel word mappings were facilitated. When the experimenter's eye-gaze was in conflict with the ...

BACKGROUND The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. METHODS Pr...

The article examines incentives for exclusive distribution of premium television programming. Static analysis shows that a vertically integrated operator with premium programming always supplies this content to the rival distributor, using per-subscriber fees to soften competition. In a dynamic setting with switching costs exclusivity confers a market share advantage, benefiting the operator in...

CONTEXT In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has...