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The COVID-19 pandemic has made obscure regulatory procedures big news across the globe. Chief among these is the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority, the expedited pathway through which COVID-19 vaccines were authorized. Not only was the EUA pathway rarely discussed before the COVID-19 pandemic, but it was also rarely used — prior to 2020, only a handful of therapeutics and a single vaccine had received an FDA EUA.

Through the EUA process described in Section 564 of the Federal, Food, Drug and Cosmetic Act, the FDA may grant expedited market access to unapproved products or for unapproved indications of approved products. The agency may do so where evidence suggests that it is “reasonable to believe” that the product “may be effective” in treating the disease or condition identified in an emergency declaration by the Secretary of the Department of Health and Human Services. This EUA process can raise a number of issues related to scientific rigor, public accountability and transparency, and political influence:

  • The streamlined EUA process raises concerns about the potential authorization of an ineffective or unsafe therapeutic given the lowered evidentiary standards for authorization
  • These flexible standards and procedures can lead to authorizations based on limited and nontransparent evidence
  • Political advocacy pressuring the agency to issue an authorization can generate suboptimal policies and negatively affect public tolerance for regulatory errors
  • Poor decision making or the appearance of it can reduce regulatory credibility and decrease public trust in the agency and the products it authorizes

The pandemic has put the FDA in a difficult position, scientifically and politically. For example, as reported in a recent Health Affairs article, had the FDA further delayed a decision on granting an EUA for convalescent plasma, the agency may have drawn additional criticism for making it harder for some patients to access the treatment. On the other hand, granting an EUA relies on less data than many in the scientific community are comfortable with and may handicap scientists’ abilities to do further research on convalescent plasma or other therapeutics. Moreover, by appearing to act in response to political demands, granting an EUA has raised concerns about the Agency’s independence and impartiality.

An improvement that the Agency could make to guard against these concerns would be to increase the clarity and transparency of the EUA process and its evidentiary standards. The FDA’s current guidance on EUAs identifies the types of evidence that might be suitable to make a determination that the product “may be effective” under section 564. It also states that the agency “plans to assess the sufficiency of the effectiveness data and the risk-benefit profile of each candidate product on a case-by-case basis.” The Agency has already shown through its public contemplation of the EUA-plus guidance that it recognizes that different products require different levels of scrutiny.

Current EUAs being withdrawn

As the nation comes to grips with the pandemic and supply chain issues lessen, after December 31, 2021 CDC will withdraw the request to FDA for Emergency Use Authorization of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.

Early in the public health emergency, there was a need to issue EUAs for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators. Today, those conditions no longer exist. Our national supply of NIOSH-approved N95s is becoming more accessible to health care workers every day.

The FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.

Still the pandemic appears to have some way to go and will, in all likelihood, continue to have an impact on FDA decision-making and the evolution of EUAs and their use. To keep abreast of potential issues that could affect your firm, contact the FDA specialists here at MEDIcept.

 

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For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.