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A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Regulating By Repute, David Zaring
Regulating By Repute, David Zaring
Michigan Law Review
Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …
Inside Agency Preemption, Catherine M. Sharkey
Inside Agency Preemption, Catherine M. Sharkey
Michigan Law Review
A subtle shift has taken place in the mechanics of preemption, the doctrine that determines when federal law displaces state law. In the past, Congress was the leading actor, and courts and commentators focused almost exclusively on the precise wording of its statutory directives as a clue to its intent to displace state law. Federal agencies were, if not ignored, certainly no more than supporting players. But the twenty-first century has witnessed a role reversal. Federal agencies now play the dominant role in statutory interpretation. The U.S. Supreme Court has recognized the ascendancy of federal agencies in preemption disputes-an ascendancy …