Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the crisis.
Suppose you are a patient taking a drug product under a REMs program that has certain elements to ensure safe use (ETASU), which require certain laboratory or radiologic tests be performed prior to continuing the product. What does the patient do if the patient is in self isolation or quarantine at the time of needing a refill of the drug during the COVID19 PHE?
This document acknowledges that such instances may occur and places the onus on the treating physician or appropriate healthcare provider to make a medical determination that the patient should forgo the particular ETASU and continue receiving the drug. Clearly, the Agency has gotten out in front of this issue and provided some insulation to the healthcare provider and access for patient so that treatment can continue without the threat of adverse action by the Agency. Remember that both regular REMS and REMs that have an ETASU remain in effect during the national health emergency, but some regulatory flexibility relying on the healthcare provider’s medical judgement is permitted in limited circumstances as outlined in the guidance document.
