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Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Faculty Works
Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …
Federal Courts Not Federal Tribunals, Lumen N. Mulligan
Federal Courts Not Federal Tribunals, Lumen N. Mulligan
Faculty Works
The Court has employed inferred-cause-of-action doctrine to foster the rights of individuals, from injured workers to female college applicants to defrauded investors and targets of racial discrimination. Although the question of whether the federal courts ought to infer causes of action from federal statutes is an old chestnut in the federal-courts field, a new basis for barring such a practice has arisen, requiring fresh attention to the Court's inferred-cause-of-action doctrine. This new position asserts that inferring a cause of action is not merely poor judicial policy but extra-jurisdictional under either 28 U.S.C. - 1331 or Article III. Borrowing a phrase …