FDA Issues New Guidance for Certain REMS Drugs During COVID-19

To address the COVID-19 coronavirus pandemic, on March 22, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

“The FDA recognizes that during the COVID-19 public health emergency, 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 or subject to quarantine,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said. “Under these circumstances, undergoing testing or imaging studies to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.”

Healthcare providers prescribing or dispensing drugs subject to REMS with laboratory testing or imaging requirements should consider whether there are compelling reasons not to complete these tests or studies during COVID-19 social distancing 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 those judgments, including their benefits and risks.

FDA does not intend to take action against sponsors and others for the duration of the COVID-19 public health emergency for failing to adhere to REMS requirements for certain laboratory testing or imaging studies.

The agency may require REMS for certain drugs if 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, such as a requirement to undergo monthly laboratory testing. Some actions may also be required for patients to continue on treatment.

The policy outlined in the guidance is effective for the duration of the COVID-19 public health emergency.