On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory testing (e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging) required by risk evaluation and mitigation strategies (REMS) may be difficult as patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Accordingly, the guidance says that during the novel coronavirus pandemic, under certain conditions, FDA does not intend to take action against drug sponsors for failing to adhere to REMS requirements for laboratory testing or imaging studies.
REMS obligations are imposed on the sponsor of the drug product, but often must be carried out by the healthcare provider. For certain drugs subject to a REMS with elements to assure safe use (ETASU), the REMS requires laboratory testing or imaging studies. The guidance urges health care providers prescribing and/or dispensing those drugs to consider whether there are “compelling reasons” to not complete those tests or studies during the coronavirus pandemic. FDA says those prescribers and dispensers must use their “best medical judgment” in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.
The guidance provides that if sponsors fail to adhere to REMS requirements for laboratory testing or imaging studies during the pandemic, they must “document and summarize in their next REMS Assessment Report steps that were taken to accommodate patient access to these REMS drugs.” In addition, any such accommodations must be made “based on the judgment of a health care professional.”
While the guidance only applies to required laboratory testing and imaging studies, in announcing the guidance, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. emphasized that the agency would “continue to work with sponsors to ensure that patients have appropriate access to the medications they need.” This policy will remain in effect for the duration of the public health emergency.
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