Browsing by Subject "Legislation, Drug"

Now showing 1 - 4 of 4

Open Access
Developing drugs for developing countries.
(Health Aff (Millwood), 2006-03) Ridley, David; Moe, Jeffrey
Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a "priority review voucher." The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer.
Open Access
Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
(Health Aff (Millwood), 2011-11) Grabowski, Henry G; Kyle, Margaret; Mortimer, Richard; Long, Genia; Kirson, Noam
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.
Open Access
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11) DiMasi, JA; Grabowski, HG
Open Access
Yopo, ethnicity and social change: a comparative analysis of Piaroa and Cuiva yopo uset.
(Journal of psychoactive drugs, 2011-01) Rodd, Robin; Sumabila, Arelis
Most Orinocoan ethnic groups, including the Cuiva and the Piaroa, use yopo, a hallucinogenic snuff derived from the seeds of the Anadenanthera peregrina tree. This study contrasts Piaroa and Cuiva attitudes toward and uses of yopo in light of ongoing processes of social change. We do not believe that these sociocultural forces will lead to a phasing out of yopo in Piaroa and Cuiva life. However, we demonstrate how, in nearby communities, a combination of historical and ethical contingencies lead to very different patterns and understanding of drug use. Yopo is strongly associated with the performance of narratives central to each ethnic group's cosmology and identity. Cuiva yopo consumption is also a means of resisting persecution and asserting the right to a just reality. Piaroa attitudes towards yopo are affected by the interplay of shamanic ethical principles and missionary activity, and are sometimes paradoxical: yopo is the reason for harm and the means of salvation; required by shamans to create the future and yet regarded by many laypeople as a relic of the past. We identify persecution, local responses to missionary activity, and shamanic ethics as key factors affecting the evolution of hallucinogen use by Amazonian ethnic groups.