November 17, 2020
By Stephen M. Hahn MD
Commissioner of Food and Drugs, Food and Drug Administration
Emergency use authorizations, or EUAs, are an important tool in our country’s fight against covid-19 and other public health emergencies. While EUAs have received increased attention during the covid-19 public health emergency, EUAs are not a new tool to the FDA. I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Earlier this year, we launched the Covid-19 Pandemic Recovery and Preparedness Plan (PREPP) to help apply best practices and lessons learned from the emergency response to date. Our goal is to optimize the ongoing covid-19 response, while also strengthening our resilience and improving our capacity to respond to future public health emergencies. As part of our overall preparedness and response work, including PREPP, we have focused on opportunities for further transparency. In particular, we recognize that disclosing information from the scientific review documents supporting the issuance, revision or revocation of EUAs for drugs and biological products, including vaccines, will contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.
As such, I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our covid-19 response. We have already posted some scientific review documents, for instance for an EUA revocation as well as an EUA authorization, and we are committing to continuing to post these documents moving forward.
Consistent with FDA’s longstanding practice of posting the relevant scientific reviews after new drug and biological product approvals, we will disclose information from EUA review documents as appropriate after our disclosure review and process is complete. As a part of this process, the FDA may redact certain information that is protected from disclosure under the law. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to the release of information that is protected from disclosure under the law.
We know that EUAs can be crucial to facilitate frontline health care providers’ access to potentially life-saving products for their patients, if those providers determine the EUA products are appropriate for their patients to use. To help health care providers understand the benefits, risks and proper use of FDA-authorized products, we have already been posting helpful information such as the letter of authorization to the requestor (which spells out the conditions under which use of the product is authorized), fact sheets for patients, fact sheets for health care providers and instructions for use. When appropriate, we have translated these materials into other languages to ensure the information is more broadly accessible. Altogether, these documents provide helpful information and transparency to the public. The additional transparency that we are announcing today, in addition to information we already provide, will help inform providers.
Let me also take a step back to explain why EUAs are such a unique and important public health tool during an emergency. The EUA process, which comes from authority that Congress gave the FDA after the attacks of September 11, 2001, can be applied to a variety of emergency situations, including pandemics like covid-19. The EUA process allows the Secretary of Health and Human Services, in appropriate circumstances, to declare that EUAs are justified for products to respond to certain types of threats. When such a declaration is made, the FDA may issue an “authorization,” which is different from our approval process for drugs and biologics, including vaccines. Under the EUA process, in emergency situations when there are no adequate, approved and available alternatives, the FDA has the authority to authorize medical products for use under specified conditions before all the evidence that would be needed for full FDA approval is available. In considering EUA requests, the agency promptly and carefully evaluates the totality of the scientific evidence that is available on the product’s safety and effectiveness to determine whether the medical product may be effective for its proposed authorized uses. As part of its overall EUA evaluation, the FDA must also determine that the product’s known and potential benefits outweigh its known and potential risks.
Let me be clear on a crucial point – the issuance of an EUA is based on data and science. For an EUA to be authorized, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product. We work with sponsors so that additional data about the product’s safety and effectiveness continue to be collected and reviewed. If the available scientific evidence changes or if new information becomes available, we can pivot and potentially adapt the EUA, including revising the authorized use or revoking the EUA. These are both steps that we have taken during the covid-19 pandemic.
Today’s transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential covid-19 vaccines. For example, as part of our commitment to covid-19 vaccine transparency, we convened FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) for an open committee meeting to discuss generally the development, licensure and authorization of COVID-19 vaccines. While no specific application was discussed at this meeting, we have stated publicly that we will promptly schedule additional meetings of the VRBPAC upon submission of an EUA request for a covid-19 vaccine to discuss whether the available safety and effectiveness data support issuance of an EUA. We’re also creating educational materials to help the public understand the different regulatory and scientific steps around vaccine or drug development, including explaining the investigational new drug processExternal Link Disclaimer, the role of data safety monitoring boardsExternal Link Disclaimer, and more.
We will continue to help expedite the development of vaccines and therapeutics for COVID-19, providing rapid feedback and technical advice to sponsors and researchers, without sacrificing our standards for quality, safety and effectiveness that all can rely on. We will also continue to follow the science and ensure that science remains the driver of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.