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Regulatory Focus™ > News Articles > 2020 > 3 > FDA Eases Some REMS Requirements Amid COVID-19

FDA Eases Some REMS Requirements Amid COVID-19

Posted 23 March 2020 | By Michael Mezher 

FDA Eases Some REMS Requirements Amid COVID-19

In an effort to ensure patient access to certain drugs during the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Sunday moved to ease laboratory testing and imaging requirements for drugs with risk evaluation and mitigation strategies (REMS) that require such measures.
 
FDA says that a limited number of drugs subject to REMS include elements to ensure safe use (ETASU) that require laboratory testing or imaging studies, such as liver enzyme testing or magnetic resonance imaging,  which may be difficult to conduct during the COVID-19.
 
“Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus,” said FDA Principal Deputy Commissioner Amy Abernethy.
 
In a new guidance that takes effect immediately, FDA explains that it does not intend to take enforcement action against sponsors and other entities who do not complete those tests based on their best medical judgement while a public health emergency (PHE) is in effect.
 
Health care providers are instructed to communicate with their patients regarding any changes to testing as a result and explain any risks patients might face by not undergoing the tests.
 
The guidance also explains that drugmakers should “document and summarize” any steps taken to ensure patient access in their next REMS Assessment Report.
 
FDA, Statement

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