The Food and Drug Administration (FDA) has issued new Expanded Access guidance to help physicians understand and use the Expanded Access process to treat patients with investigational drugs and biologics during the COVID-19 public health emergency.
The new guidance allows physicians applying for single-patient expanded access to request a waiver of the FDA requirement for full institutional review board (IRB) review. If the waiver is granted, the review can be conducted by the IRB chair or a designated IRB member.
In addition, the guidance states that any review of the Expanded Access request—by the full IRB or a designated member—should only consider the risks and benefits to the patient involved.
FDA issued the guidance in response to a “substantial increase” in Expanded Access requests during the COVID-19 pandemic. Although the guidance is only in effect for the duration of the public health emergency, FDA notes that the recommendations could serve as the basis for efforts to continue to facilitate Expanded Access beyond the pandemic.