Renovations needed: The FGA’s floor/ceiling framework, preemption, and the opioid epidemic

Abstract

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 pre-market 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 argues that the FDA’s administrative design mis-allocates the costs of the Opioid Epidemic and fails to adequately compensate those injured by it. Part I summarizes the FDA’s regulatory framework with respect to opioid medications. Part II explains how that framework creates a compensatory problem that prevents the internalization of negative external-ities by pharmaceutical manufacturers. Part III proposes a victims’ compensation fund as the best substitute for the functions long performed by state tort liability.