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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 …
Medicaid And The Unconstitutional Dimensions Of Prior Authorization, Jagan Nicholas Ranjan
Medicaid And The Unconstitutional Dimensions Of Prior Authorization, Jagan Nicholas Ranjan
Michigan Law Review
The political outcry over prescription drug costs has been one of the most vociferous in recent memory. From tales depicting renegade seniors sneaking cheap prescriptions of Vioxx out of Tijuana across the border, to the promises of reduced prices made by front-runners during the 2000 Presidential election, the calls for lower drug prices have been forceful and demanding. This war for lower-priced pharmaceuticals fought by consumers, interest groups and politicians against the pharmaceutical industry itself has recently developed yet another front. The latest battle is over Medicaid. The new victims are the poor. Presently, federal statutory provisions in the Medicaid …