MONDAY, MARCH 23, 2020

FDA ISSUES GUIDANCE CONCERNING REMS REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY.  The Food and Drug Administration (FDA) has issued guidance to health care professionals concerning REMS adherence during the COVID-19 public health emergency.  That guidance is found here In its most pertinent part, that guidance states:

For a limited number of drugs that are subject to a REMS with ETASU, the REMS requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging) under sections 505-1(f)(3)(d) or (e) of the FD&C Act (21 U.S.C. 355-1 (f)(3)(d) or (e)).

FDA recognizes that during the COVID-19 PHE, completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus.

For drugs subject to these REMS with laboratory testing or imaging requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during the PHE, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.  Health care providers should also communicate with their patients regarding these judgments, including the risks associated with it.

Although all REMS requirements remain in effect, FDA does not intend to take enforcement action against sponsors or others for accommodations made regarding laboratory testing or imaging study requirements imposed under sections 505-1(f)(3)(d) or (e) of the FD&C Act (21 U.S.C. 355-1 (f)(3)(d) or (e)) during the PHE declared by the Secretary of HHS on January 31, 2020, provided that such accommodations were made based on the judgment of a health care professional.  Manufacturers should document and summarize in their next REMS Assessment Report steps that were taken to accommodate patient access to these REMS drugs during this COVID-19 PHE.  

*UPDATE*  The Journal of Psychiatry & Neuroscience has published guidance on the use of clozapine during the COVID-19 pandemic, which is described as "not intended as a definitive treatment strategy but as a suggested approach for clinicians treating patients with similar histories."   The guidance is found here.