FDA Issues Updated Draft Guidance for Emergency Use Authorizations: Emphasis on IVDs and Government Agencies

April 12, 2016

By Allyson B. Mullen

On April 1, FDA issued an updated draft guidance regarding the policies and procedures for Emergency Use Authorizations (EUAs). The EUA procedures cover all types of medical products including drugs and biologics (e.g., vaccines and therapeutics) and devices (e.g., personal protective equipment and in vitro diagnostic tests).  The updated draft guidance is intended to replace the 2007 and 2009 draft guidances on this same topic.  The substance of the updated guidance is relatively unchanged from the 2007 draft, with the exception of a few key points, discussed below.

IVDs.  The updated draft guidance provides more specific guidance with regard to IVDs.  For example, the update guidance now gives examples of both effectiveness and safety data that should be included in an IVD EUA application.  This information is particularly useful for IVD manufacturers given the need for adequate tests to diagnose disease that present emergencies, such as Zika and Ebola.  In fact, the majority of current EUAs relate to diagnostic products (see a list of currently in effect EUAs here).

In addition, the updated guidance provides information regarding categorization of diagnostic tests (i.e., point-of-care versus laboratory use). An authorized diagnostic test will be deemed waived if FDA determines that “the categorization would be beneficial to protecting the public health; and the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.”  This categorization is independent of the CLIA categorization for an approved or cleared test and will last as long as the EUA is authorized. 

Government Entities.  The 2007 draft guidance indicated that applications for EUAs could come from both government and private entities.  The updated guidance, however, suggests that government entities rather than private entities are likely to be sponsors of EUAs.  The updated guidance indicates it is FDA’s experience that government entities submit the most requests for EUAs.  We found this addition curious because according to FDA’s website the currently authorized EUAs are split pretty evenly between government and private entities.

The updated guidance also indicates that private entities seeking EUAs should “first seek support from relevant governmental stakeholders that may be engaged in official response efforts (e.g., HHS ASPR, CDC, DoD, or state/local public health authorities) to ensure that the use encompassed by the request is appropriately coordinated and will not interfere with official response plans.” While this addition to the guidance appears logical, adding a step of contacting a government agency, will likely slow down and may even deter private entities attempting to have its product authorized under an EUA.  It is unclear if FDA would refuse an EUA if a private applicant does not (or is unable to) obtain input from the relevant governmental authorities.

Fact Sheets. Although the updated guidance continues to provide helpful instruction regarding the type of information required in an EUA application, it omits the Appendices from the 2007 draft guidance, templates for the EUA Fact Sheets.  Fact Sheets are documents provided to the healthcare professionals and recipients of the unapproved product describing, among other things, the product and its emergency use.  It is unclear from the draft guidance whether FDA intentionally omitted these appendices because it no longer thinks the forms are applicable.  Absent clear indication from FDA that these forms should no longer be used, entities planning to submit an EUA should be aware of these older templates.  Copies of the templates can be found in the original draft guidance, here.