Renovations Needed: the FDA's Floor/Ceiling Framework, Preemption, and the Opioid Epidemic

Area of Science:

• Pharmaceutical regulation
• Public health policy
• Legal studies

Background:

• The U.S. Food and Drug Administration (FDA) employs a regulatory framework for pharmaceuticals characterized by a "floor/ceiling" model.
• Administrative rules establish a minimum safety "floor," while state tort liability provides a "ceiling" for maximum protection.
• This system prioritizes pre-market review but relies heavily on post-market state common law to regulate pharmaceutical products.

Purpose of the Study:

• To analyze the imbalance in the FDA's regulatory framework, particularly concerning the opioid crisis.
• To examine how the preemption of state tort law by federal standards exacerbates this imbalance.
• To argue that the current FDA framework misallocates the costs of the opioid epidemic and inadequately compensates injured parties.

Main Methods:

• Review of the FDA's regulatory framework for opioid medications.
• Analysis of the compensatory problem arising from the framework, focusing on the internalization of negative externalities by pharmaceutical manufacturers.
• Proposal of a victims' compensation fund as an alternative to state tort liability.

Main Results:

• The increasing preemption of state tort law by federal administrative standards has created an imbalance in the FDA's regulatory framework.
• This imbalance allows the pharmaceutical industry to avoid bearing the public health costs associated with their opioid products.
• The existing framework fails to adequately compensate individuals harmed by prescription opioid medications.

Conclusions:

• The FDA's current administrative design inadequately addresses the financial and public health consequences of the opioid epidemic.
• Pharmaceutical manufacturers are not fully internalizing the societal costs of their opioid products due to regulatory loopholes.
• A dedicated victims' compensation fund is proposed as a viable mechanism to replace the protective functions of state tort liability and ensure victim compensation.