The Food and Drug Administration (FDA) announced policy changes related to required testing for certain medications that are prescribed under a Risk Evaluation and Mitigation Strategy (REMS) program. These changes will be in effect for the duration of the coronavirus disease 2019 (COVID-19) public health emergency.
Under the temporary policy, clinicians who prescribe or dispense medications that include certain laboratory testing or imaging requirements under a REMS program are being asked to consider “whether there are compelling reasons not to complete these tests or studies during the [public health emergency], and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.”
“The completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “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.”
In a press statement, the agency noted that while it would not take action against those who fail to adhere to certain lab and imaging requirements during the public health emergency, the REMS requirements will still remain in effect. In addition, for some drugs, laboratory testing or other actions may be essential to ensure safe use prior to prescribing or dispensing.
For more information visit fda.gov.