1. Pink Sheet

Coronavirus Product Communications Would Get Safe Harbor Under Senate Bill

 
• By Sue Sutter

In what could be the first major use of the Emergency Use Authorization pathway, manufacturers would be able to disseminate information based on ‘competent and reliable scientific evidence’ that is truthful, non-misleading and directed at population-level decision makers. The measure would define the CARSE standard in the FD&C Act for first time, attorneys say.

An empty red emergency box with an in case of emergency breakable glass on the front on an isolated background - 3D render
The use of EUAs for tackling the COVID-19 pandemic are raising novel questions for manufacturers. • Source: Shutterstock

A COVID-19 legislative aid package unveiled by US Senate Republicans on 19 March would protect manufacturer communications about drugs and devices marketed under an Emergency Use Authorization granted by the Food and Drug Administration.

The Coronavirus Aid, Relief and Economic Security (CARES) Act (S

Under the measure, such communications would not be viewed as misbranded or as evidence of intent to promote a new use as long as they are truthful and nonmisleading, based on “competent and reliable

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