COVID-19 Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-update-patient-access-certain-rems-drugs-during-covid-19?utm_campaign=SBIA%3A%20COVID-19%20Update%3A%20FDA%20provides%20update%20on%20patient%20access%20to%20certain%20REMS&utm_medium=email&utm_source=Eloqua

COVID-19 Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time. For drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during this public health emergency (PHE) and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.  They should also communicate with their patients regarding these judgments including their benefits and risks. The FDA does not intend to take action against sponsors and others for the duration of the public health emergency for failing to adhere to REMS requirements for certain laboratory testing or imaging studies. The FDA may require REMS for certain drugs if the agency determines that it is necessary to ensure that the benefits of the drug outweigh its risks.

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