FDA Provides Access to Certain REMS Drugs

As part of the U.S. FDA's efforts to address the coronavirus pandemic, 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 lab 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 lab testing and imaging studies.  

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. Generally, REMS may include a medication guide, a patient package insert, a communication plan, and certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose. The FDA also may require certain elements to assure safe use (ETASU) as part of REMS for a drug. ETASU are medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient such as a requirement to undergo monthly laboratory testing.

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