During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies. Providers should communicate their medical judgments and the risks to their patients, and manufacturers should document and summarize steps taken to accommodate patient access to such drugs in their next REMS assessment report to FDA.

Through its guidance document for industry and healthcare providers (HCPs), Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, the US Food and Drug Administration (FDA) is offering enforcement discretion for certain laboratory testing and imaging study requirements that are in force for a subset of drugs and biologics that are subject to Risk Evaluation and Mitigation Strategies (REMS). For these products, FDA previously determined that laboratory testing and/or imaging studies were necessary to ensure safe use.

However, FDA recognizes that it may be difficult for patients to obtain laboratory tests (e.g., liver enzyme testing or platelet count) and imaging studies (e.g., magnetic resonance imaging) during the current public health emergency (PHE), due to avoidance of public places, self-isolation/quarantine, or sheltering in place. Accordingly, to avoid putting patients and others at risk, FDA is temporarily lifting the testing/imaging prerequisite so that patients will not be barred from obtaining their medicines.

Rather, HCPs prescribing or dispensing REMS drugs are advised to do the following:

• “[C]onsider whether there are compelling reasons not to complete” the tests or studies.
• Use “their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.”
• Discuss these medical judgments with patients, including the risks of forgoing the tests or studies.

FDA also stated that it temporarily does not intend to take enforcement action against drug and biologic application sponsors or others that monitor, evaluate or keep records on these REMS requirements, if they provide accommodations with respect to laboratory testing or imaging studies.

Sponsors of REMS drugs should ensure that

• accommodations are solely based upon an HCP’s professional medical judgment;
• records related to any laboratory test/imaging accommodations are maintained;
• accommodations are documented and summarized in the next REMS Assessment Report to FDA; and
• they continue to comply with and document other REMS requirements because, notably, this guidance only relates to laboratory testing and imaging studies. It does not relate to other REMS requirements, such as requirements related to in-person product administration.

Coronavirus COVID-19 Task Force

For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold.