Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997
Author
Brown, Nathan A.
Metadata
Show full item recordCitation
Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization and Accountability Act of 1997 (1998 Third Year Paper)Abstract
Part I of this paper reviews the perceived need for greater pediatric drug information and previous attempts at improving pediatric pharmaceutical treatment. Part II summarizes SOSA itself in relation to current patent and exclusivity provisions. Part III examines 505A in light of the current regulatory system and financial incentives, arguing that greater FDA discretion in implementing the provision and/or greater reliance on market forces would make SOSA more effective. Finally, Part IV argues that SOSA should be expanded beyond pediatric studies, to provide incentive for further drug studies for adult indications as well.Terms of Use
This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAACitable link to this page
http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852147
Collections
- HLS Student Papers [498]
Contact administrator regarding this item (to report mistakes or request changes)