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Full-Text Articles in Law
Hatch-Waxman’S Renegades, John R. Thomas
Hatch-Waxman’S Renegades, John R. Thomas
Georgetown Law Faculty Publications and Other Works
No intellectual property rights impact society more forcefully than patents on pharmaceuticals. But as a practical matter, only a handful of jurists resolve disputes involving them. Two neighboring federal districts, Delaware and New Jersey, adjudicate the vast majority of patent contests between brand-name drug companies and generic manufacturers. And in contrast to Eastern Texas, which has been persistently derided as a renegade jurisdiction, the authority of the mid-Atlantic courts has seldom been questioned. The complex workings of the Hatch-Waxman Act, the compromise legislation that governs pharmaceutical patent litigation, go a long way to explaining such distinct shareholder reactions to highly …
Why Care About Mass Incarceration?, James Forman Jr.
Why Care About Mass Incarceration?, James Forman Jr.
Georgetown Law Faculty Publications and Other Works
The United States incarcerates more of its citizens than any other nation in the world. Paul Butler’s Let’s Get Free: A Hip-Hip Theory of Justice makes an important contribution to the debate about the crime policies that have produced this result. Butler began his career as a federal prosecutor who believed that the best way to serve Washington, D.C’s low-income African-American community was to punish its law-breakers. His experiences—including being prosecuted for a crime himself—eventually led him to conclude that America incarcerates far too many nonviolent offenders, especially drug offenders. Let’s Get Free offers a set of reforms for reducing …
Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard
Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard
Georgetown Law Faculty Publications and Other Works
This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …