FDA Eases Restrictions on Use of Drugs Requiring REMS Testing

As the race to find effective treatments for novel coronavirus continues, drug regulators are making it easier for clinicians to use all of the medications in their arsenal. Find out how the FDA is loosening restrictions on drugs requiring Risk Evaluation and Mitigation Strategy for the duration of the public health emergency.

WASHINGTON, DC – In response to the coronavirus pandemic, the U.S. Food and Drug Administration’s the agency issued a new guidance to sponsors and healthcare providers loosening restrictions on drugs requiring Risk Evaluation and Mitigation Strategy (REMS) 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,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in an announcement. “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.”

The agency explains that, for drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers prescribing and/or dispensing the drugs should consider “whether there are compelling reasons not to complete these tests or studies during this public health emergency (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.”

The FDA also instructs clinicians to communicate with their patients regarding their judgments, including their benefits and risks.

Federal drug regulators say they do not plan to take action against sponsors and others for the duration of the public health emergency for failing to adhere to REMS requirements for certain laboratory testing or imaging studies.

REMS are required for certain drugs if the FDA determines that it is necessary to ensure that the benefits of the drug outweigh its risks. In most cases, REMS include a medication guide, a patient package insert, a communication plan, and certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose.

In addition, the FDA also sometimes requires certain elements to assure safe use (ETASU) as part of REMS for a drug. ETASU are medical interventions or other actions healthcare professionals are required to take prior to prescribing or dispensing the drug to the patient, such as a requirement to undergo monthly laboratory testing. Patients might not be able to continue on the treatment if those hurdles aren’t met.

The FDA writes that the policy outlined in the guidance will be in effect for the duration of the public health emergency.

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