Regulatory Focus™ > News Articles > IOM: In Disaster Situation, FDA Will Be Crucial

IOM: In Disaster Situation, FDA Will Be Crucial

Posted 21 March 2012 | By Alexander Gaffney, RAC 

A publication by the US Institute of Medicine (IOM) on the topic of emergency preparedness says the US Food and Drug Administration (FDA) will be crucial to efforts to ensure safe and effective medications make it to consumers during an emergency scenario.

While IOM's report, Crisis Standards of Case: A Systems Framework for Catastrophic Disaster Response, places FDA in a key role for carrying out rapid benefit:risk assessments and mitigating legal liability for manufacturers, IOM thinks there remains work to expand those protections. Currently, legal liability protections under EUA's are only in effect during an emergency, which could leave manufacturers exposed to risk after an emergency is alleviated or averted.

FDA is authorized to issue emergency use authorizations (EUAs) under the Public Readiness and Emergency Preparedness Act (PREP Act), which in turn provides legal liability protection to the manufacturers of products being distributed for that emergency. These products are likely to be unapproved or off-label in certain emergency scenarios, such as a bird flu pandemic.

In order to quality for an EUA under PREP, a company must convince FDA their product will be effective-and on balance beneficial-in diagnosing, treating or preventing a life-threatening or serious disease or condition, and that no other product exists to treat the condition.


Read more:

IOM - IOM Report Provides Framework and Tools to Deliver Health Care Effectively During Catastrophic Disasters


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