USA – When a REMS is Necessary: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2016 detailing the factors that the agency uses to determine whether a risk evaluation and mitigation strategy (REMS) is necessary for a drug.

As defined by the guidance, a REMS is a required risk management plan that can include one or more elements to ensure that the benefits of a drug outweigh its risks. Such elements can include a medication guide, a package insert or a communication plan

And though the use of a REMS is decided on a case-by-case basis, the 10-page guidance explains how the Food and Drug Administration Amendments Act (FDAAA) requires FDA to consider the following six factors in deciding whether to require a REMS:

  • “The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug;
  • The expected benefit of the drug with respect to the disease or condition;
  • The seriousness of the disease or condition that is to be treated with the drug;
  • Whether the drug is a new molecular entity;
  • The expected or actual duration of treatment with the drug; and
  • The estimated size of the population likely to use the drug.”…