FDA Issues COVID-19 Drug Safety Guidance

FDA updates risk evaluation strategy to address COVID-19 health emergency

(RxWiki News) The US Food and Drug Administration (FDA) is relaxing certain risk evaluation requirements in an effort to help address the COVID-19 pandemic.

More specifically, the FDA sent new guidance to health care providers about Risk Evaluation and Mitigation Strategy (REMS)-required testing. This move is meant to allow health care providers to more quickly prescribe drugs to treat people who are thought to have COVID-19, the agency said.

A REMS is a program of drug safety and testing requirements that the FDA places on certain medications that can pose serious health and safety concerns. While these measures are meant to protect patient health, they can sometimes slow down prescribing of medications that are subject to them. A REMS might include specified packaging, a communication plan and a patient package insert with the medication in question.

“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 Dr. Amy Abernethy in a 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."

Calling the COVID-19 pandemic a public health emergency, the FDA noted that health care professionals should consider whether there are "compelling reasons" not to complete certain tests or studies related to coronavirus testing while the crisis continues.

They should also explain to their patients all possible risks, as well as the potential benefits, of skipping certain REMS requirements.

Typically, the FDA will take action against health care providers who do not follow REMS requirements. In light of this public health emergency, however, the agency said it will not take any such action as long as the problem continues.

If you have any questions, speak with your health care provider.

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Review Date: 
April 27, 2020