Emergency Use Authorization (EUA) Product vs FDA-Approved Product

The COVID-19 pandemic prompted the rapid development of diagnostic testing products to identify patients with the virus and vaccines to protect patients from contracting the virus.  This rapid development created broad awareness of the FDA’s Emergency Use Authorization (EUA) authority to help protect the public in health emergencies.  The number of products that received EUA in 2020 appears to exceed the number of EUAs seen for Anthrax, Ebola, Zika, or other health crises prior to this pandemic. EUAs are needed because the typical approval process takes too much precious time, prolonging a public health emergency.  Looking forward to when these products receive FDA approval for non-emergency use, there are industry considerations to facilitate a smooth transition from utilizing EUA products to using FDA-approved products.

Currently, EUA tests and vaccines are provided free of charge.  However, it is likely that once the same product receives FDA approval for commercial use, pharmaceutical manufacturers will charge for these products.  Therefore, for the purposes of inventory tracking, patient profile management, and claims submission, it is important that EUA product does not become confused with the FDA-approved commercial product.

To accomplish that, manufacturers should obtain an NDC for the commercially approved product that is different than the NDC given to the EUA product.  The product code of the NDC (middle segment) and/or the package size identifier of the NDC (last segment) should change in a way that clearly distinguishes between the EUA and approved product.  National Council for Prescription Drug Programs (NCPDP) encourages manufacturers to obtain new NDCs in this situation.

Since the NDCs for EUA products are listed by the drug compendia with no associated cost, the new NDC can be listed with the cost determined by the manufacturer, without affecting the EUA NDC. Different NDCs will provide the means for proper claims submission, indicating the product that was utilized, and allows the healthcare provider to log the appropriate product on the patient’s profile.  This will also help to track and separate inventory of unapproved EUA products in the channel before and after FDA approval of the commercial product.

Lastly, and most important, obtaining a new NDC for approved commercial products will help ensure there is no delay or denial for vaccine administration because of confusion stemming from EUA and FDA-approved product represented by the same NDC.

 

Posted: December 2020

2 responses to “Emergency Use Authorization (EUA) Product vs FDA-Approved Product”

  1. Robert C. Shepherd says:

    this is an interesting article. do you have anything more on this subject. is this dual ndc a requirement or mandate of the EUA?….would like to discuss more if possible. thanks rob s.

    • Alan Sekula says:

      Rob,

      Thanks for reading our blog and providing your comment! There is no current mandate that we are aware of for the use of a new NDC for an product that only changes from an EUA to FDA-Approved without any other change (name, size, etc.). NCPDP is also an advocate of the use of a new NDC in this scenario. Keeping the same NDC poses a risk of possible confusion and ensuing issues or problems with inventory tracking, patient management and records, and payable claims in the market. We’ll follow up with you to discuss further.

      We encourage you to keep reading our posts and please don’t hesitate to send further questions or comments.

      Thanks again,
      The PHSL Team

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