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Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
Robin C Feldman
The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …
Federalism, First Amendment & Patents: The Fraud Fallacy, Robin C. Feldman
Federalism, First Amendment & Patents: The Fraud Fallacy, Robin C. Feldman
Robin C Feldman
Few arguments echo as strongly throughout United States constitutional history as those related to the role of the states in the federal union. Shifting across time, the role of the states in general has moved from a model of dualism — characterized by a strict separation of federal and state dominion — to a model of overlapping and concurrent powers. In the modern context of overlapping powers, the preemption doctrine manages the intricate areas of overlap, with topics ranging from antitrust to immigration.
Yet the concept of federalism, as applied by the circuit courts in relation to patents, has traveled …