Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule
Abstract
Effective treatment approaches in a pandemic, such as coronavirus disease 2019 (COVID-19), hinge on expeditious identification of sound dosing strategies. Informed by experience with the US Food and Drug Administration (FDA) Animal Rule, this commentary illustrates a framework for leveraging and integrating clinical pharmacology information for dose selection to treat novel infections in a public health emergency setting. Fighting a novel pathogen like severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, involves coordinated response planning for efficient and rapid detection, diagnosis, prevention, and treatment.1 An efficient approach to identify treatments for a novel pathogen is to repurpose a drug that has been approved or is under development for other indications. Effective treatment approaches in a pandemic hinge on expeditious identification of sound dosing strategies of drugs and biologics targeting the infecting pathogen. In the early stage of a pandemic outbreak, little is known about the novel pathogen and the disease it causes. In this setting of great uncertainty, leveraging known clinical pharmacology information for dose selection is vital for effective treatment of infection. The dose selection framework outlined in the FDA Animal Rule regulation provides an approach for dose determination in settings of urgent need with limited information. The genesis of the Animal Rule development pathway followed the 2001 anthrax…
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