APhA coronavirus watch: FDA issues new guidance on patient access to REMS drugs

On March 22, FDA issued new guidance on required testing for the Risk Evaluation and Mitigation Strategy (REMS) program. Although all REMS requirements remain in effect, the agency said it will not take enforcement action against health care providers or sponsors for failing to adhere to REMS requirements for certain laboratory testing or imaging studies 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 and/or subject to quarantine,” stated FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a press release.

“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. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.”

Providers who prescribe or dispense drugs that are subject to REMS with laboratory testing or imaging requirements should consider whether there are compelling reasons not to complete these tests or studies, FDA said. They should use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of testing or studies and communicate with their patients about these judgments. 

The guidance, available at www.fda.gov/media/136317/download, will be in effect for the duration of the COVID-19 public health emergency.