FDA Issues Guidance on REMS Requirements During Public Health Emergency

March 23, 2020

The FDA announced that it will take no action against any party for failure to adhere to REMS during the the SARS-CoV-2 public health emergency.

The US Food and Drug Administration (FDA) on Sunday, March 22, 2020, announced that it will not take action against sponsors and other parties for failing to adhere to risk evaluation and mitigation strategies (REMS) for certain laboratory testing or imaging studies and that suspension of any punitive action will remain in effect for the duration of the SARS-CoV-2 public health emergency.

The Guidance for Industry and Health Care Professionals, which FDA states is being implemented without prior public comment, was drafted in response to queries to the Agency about REMS that require laboratory monitoring and how patient access to affected medications would be impacted if patients are unable to leave their homes to pursue such testing.

“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 and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in an Agency 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."

Related: FDA Takes 2 Significant Actions in Aggressive Fight Against COVID-19

REMS for a limited number of drugs include elements to assure safe use, or ETASU, eg, monthly laboratory testing for liver enzyme levels, imaging such as MRI studies or other interventions clinicians must execute before they prescribe or dispense the drug. Some actions may be required as a condition of continuation of treatment.

As listed in the FDA guidance, ETASU may require any one or a combination of the following:

  • Health care providers who prescribe the drug have particular training or experience, or are specially certified;

  • Pharmacies, practitioners, or health care settings that dispense the drug are specially certified;

  • The drug be dispensed to patients only in certain health care settings, such as hospitals;

  • The drug be dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results;

  • Each patient using the drug be subject to monitoring; or

  • Each patient using the drug be enrolled in a registry

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FDA guidance to clinicians

For drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during this 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. They should also communicate with their patients regarding these judgments including their benefits and risks.

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The FDA states in the guidance document that this type of communication from the Agency does "not establish legally enforceable responsibilities." Rather, guidance shares current FDA thinking on the topic at hand and should be viewed as a recommendation only "unless specific regulatory or statutory requirements are cited." Thus, the word "should" in FDA guidance should be understood as something suggested or recommended, and not required.

The FDA, according to Dr Abernathy's statement in the press release "... will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.” 

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