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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 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 …

Regulating Carcinogens In Food: A Legislator's Guide To The Food Safety Provisions Of The Federal Food, Drug, And Cosmetic Act, Richard A. Merrill

Michigan Law Review

On March 9, 1977, the Food and Drug Administration (FDA) announced that a study in laboratory rats conducted by the Canadian government confirmed that saccharin is an animal carcinogen. For this reason, the agency stated, the sweetener must be banned from human food.

The studies which Congress mandated, to be accompanied by the recommendations of the Secretary of HEW, are likely to generate a fundamental reexamination of the nation's current food safety policies. This Article attempts to aid this inquiry by explaining the requirements of the present law. The Article describes the several statutory provisions that govern the regulation of …