FDA Proposes Changes to Expanded Access Procedure


Changes address concerns that the process to access investigational drugs was too difficult.

Changes address concerns that the process to access investigational drugs was too difficult.

The US Food and Drug Administration (FDA) has issued a draft guidance on the Expanded Access Applications for patients wanting to use medications that have not been approved (yet). In a FDA blog, Peter Lurie MD, MPH, associate FDA commissioner for public health strategy and analysis wrote that the FDA has “heard concerns from patients and physicians that the process for gaining access to investigational drugs was too difficult.” As a result, they have created a draft guidance that they hope will make the process simpler.

The new draft document, “Individual Patient Expanded Access Applications: Form FDA 3926,” proposes that a simplified application form be used for requesting the investigational medications — even during an emergency.

Current Application —

26 types of information and 7 attachments

Dr. Lurie noted that under the current system, expanded access requires 26 separate types of information and 7 attachments. Part of the complexity is likely due to the that fact that the expanded access program was originally designed for manufacturers seeking to begin human testing and not for physicians seeking use by single patients.

Proposed Application —

8 types of information and 1 attachment

The new proposal will hopefully make the ability for physicians to give their patients an investigational drug much easier. Dr. Lurie pointed out however, that the expanded access program still has the same rigorous requirements to obtain the medications but that the process will be easier.

Click here to read the full article on Rare Disease Report

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