Emergency Use Authorization

Emergency Use Authorization
Name	Emergency Use Authorization
Country	United States
Administering agency	Food and Drug Administration
Established	2004 (via the Project BioShield Act)
Related legislation	Public Health Service Act, Federal Food, Drug, and Cosmetic Act

Emergency Use Authorization. It is a mechanism by which the Food and Drug Administration can facilitate the availability of medical countermeasures during declared public health emergencies. This legal tool allows for the temporary use of unapproved medical products or the unapproved use of approved products when certain criteria are met. The authority is a critical component of the United States Department of Health and Human Services preparedness and response framework.

Definition and legal basis

The legal foundation was established under Section 564 of the Federal Food, Drug, and Cosmetic Act, as amended by the Project BioShield Act of 2004. This statute grants the Secretary of Health and Human Services the power to declare that circumstances justify emergency authorization. Such a declaration is made in consultation with the Assistant Secretary for Preparedness and Response and other federal entities like the Centers for Disease Control and Prevention. The authority was further clarified and expanded by the Pandemic and All-Hazards Preparedness Reauthorization Act. The provision operates alongside other emergency powers like those in the Public Readiness and Emergency Preparedness Act.

Criteria and process

For issuance, the Commissioner of Food and Drugs must determine several statutory criteria are satisfied. These include that the agent specified in the declaration can cause a serious or life-threatening disease or condition. It must also be shown that the product may be effective and that its known and potential benefits outweigh its known and potential risks. Furthermore, there must be no adequate, approved, and available alternative to the product. The review process involves rigorous evaluation of data by teams within the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. Sponsors typically submit a request that includes manufacturing information and available clinical trial data.

Historical examples

Notable historical instances include authorizations during the 2009 H1N1 influenza pandemic for antiviral medications and diagnostic tests. During the 2014-2016 Western African Ebola virus epidemic, several investigational therapeutics and vaccines received this status. The most extensive use occurred during the COVID-19 pandemic, with authorizations for mRNA vaccines from Pfizer and Moderna, the viral vector vaccine from Johnson & Johnson, and numerous diagnostic tests like those from Abbott Laboratories and Roche. Monoclonal antibody treatments such as bamlanivimab and oral antivirals like Paxlovid were also made available through this pathway.

Comparison to full approval

The key distinction from full approval, granted via a Biologics License Application or New Drug Application, is the lower evidence threshold and temporary nature. Full approval requires submission of substantial evidence of effectiveness from adequate and well-controlled studies, typically including completion of Phase III trials. In contrast, authorization can be based on the totality of scientific evidence available, which may include preliminary clinical data. Products under this mechanism also carry different labeling requirements, including fact sheets for providers and patients. Post-authorization monitoring and requirements for sponsors to pursue full approval are standard conditions.

Controversies and criticisms

The process has faced scrutiny regarding the potential for political pressure, as suggested during the COVID-19 pandemic with discussions around hydroxychloroquine and convalescent plasma. Some experts from institutions like the Johns Hopkins Bloomberg School of Public Health have raised concerns about eroding public trust if perceived standards are compromised. The communication of benefits and risks, especially for novel platforms like mRNA vaccines, has been a significant challenge. Debates have also occurred over the appropriate timing for issuing authorizations for vaccines for younger pediatric populations.

Impact on public health

The mechanism has had a profound impact by dramatically accelerating access to critical countermeasures during crises. During the COVID-19 pandemic, it enabled the rapid deployment of vaccines, which were credited with preventing millions of hospitalizations and deaths according to models from the Commonwealth Fund. It has streamlined the rollout of diagnostics, aiding surveillance efforts by the World Health Organization. The framework has served as a model for other regulatory agencies, including the European Medicines Agency and Health Canada. The experience has informed ongoing discussions about global regulatory harmonization through forums like the International Coalition of Medicines Regulatory Authorities.

Category:Food and Drug Administration Category:United States public health legislation Category:Medical law