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Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
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 …
Refunding Overcharges Under The Emergency Petroleum Allocation Act: The Evolution Of A Compensatory Obligation, Michigan Law Review
Refunding Overcharges Under The Emergency Petroleum Allocation Act: The Evolution Of A Compensatory Obligation, Michigan Law Review
Michigan Law Review
The DOE's authority to order noncompensatory remedies has been seriously questioned. This Note will evaluate the propriety of such remedies in light of the history of petroleum price control enforcement. Although the DOE's enabling legislation does not explicitly impose a compensatory obligation, the Note finds that Congress anticipated that remedies would compensate, to the extent feasible, those persons actually overcharged. Part I traces the development of a compensatory obligation through the various stages of price regulation. Part II criticizes the DOE for abnegating that obligation. The Note concludes that the Department's recent consent orders violate both its own rules and …