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Full-Text Articles in Law
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
Faculty Publications
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …
The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain
The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain
Business and Economics Faculty Publications
As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …