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Michigan Law Review

Administrative Law

Food and Drug Administration

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Full-Text Articles in Law

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams Jan 2018

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …


Regulating Black-Box Medicine, W. Nicholson Price Ii Dec 2017

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …


Regulating By Repute, David Zaring Apr 2012

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 Feb 2012

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 …