FDA’s commitment to transparency

Transparency in the decisions that the FDA makes in its scientific review of drugs and biologics is an important element of FDA’s mission to protect the public health, particularly as we announce the agency’s decisions on COVID-19 vaccine submissions. As the research and development of vaccines and treatments for COVID-19 continue, I want to reaffirm the commitment of the FDA to transparency. We will publicly share information on FDA’s decisions, especially around Emergency Use Authorizations (EUAs), to promote public confidence in the FDA’s scientific review process and the appropriate use of the authorized products.

EUAs are a critical tool in the FDA’s arsenal to respond to public health emergencies, such as the COVID-19 pandemic. When, based on a determination of an emergency, the secretary of Health and Human Services declares that issuance of EUAs is justified, the FDA may authorize a medical product for emergency use if it is reasonable to believe that the product may be effective based on the totality of scientific evidence available, if there are no adequate, approved, and available alternatives, and if the product’s known and potential benefits outweigh the known and potential risks. The EUA process enables the FDA to move as quickly and safely as possible to support the early availability and development of promising products in emergency situations such as the one we are in, while ensuring they meet FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

These are real-time decisions using rapidly evolving data about a previously unknown, highly contagious virus. A key difference between an EUA and a full approval is the amount of information needed at the time of FDA’s review. EUAs are reviewed earlier in the development process and the complete safety and efficacy information may not yet be known or available at the time of FDA review. FDA’s career scientists continue to carefully consider the benefits and risks of a product throughout the pandemic, which means that EUAs can be revised or even revoked as new data emerges.

We recognize that in the past, the scientific rationale for FDA’s decisions around EUA issuance, revisions, and revocations have not always been consistently disclosed and we have heard a significant amount of feedback on this. To address this, on Nov. 17, 2020, I announced that FDA’s drug and biological product centers intend, to the extent appropriate and permitted by law, to make publicly available their reviews of the scientific data and information regarding EUAs issued, revised, or revoked for drugs and biological products, including vaccines, as part of our ongoing COVID-19 response. The extent of the information posted will depend on applicable laws, including those protecting sponsors’ proprietary information. We have already posted some scientific review documents, and we are committing to continuing to post these documents moving forward.

The EUA process has led to significant milestones in battling this devastating pandemic, including most recently, on Dec. 11, 2020, the FDA’s authorization for emergency use of the Pfizer BioNTech COVID-19 vaccine for individuals 16 years of age and older, the first COVID-19 vaccine authorized in the United States. We have made available to the public the FDA’s evaluation of the available evidence and benefit-risk assessment, as well as fact sheets that provide important information to vaccine providers and vaccine recipients, including dosing instructions and information about the benefits and risks.

Additionally, documents related to FDA advisory committees, such as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings for COVID-19 vaccine candidates, including briefing documents and presentations, are available on FDA’s website for advisory committees, including the Dec. 10, 2020 VRBPAC meeting. In addition, the VRBPAC meetings on COVID-19 vaccines are all openly live-streamed to the public, with recordings and transcripts posted on FDA’s website afterwards. During the Dec. 10, 2020 VRBPAC meeting, more than 230,000 people joined the live-stream over the course of the day and were able to listen, in real-time, to the scientific discussions. Public discussions on the efficacy of the vaccine as well as the side effects seen in clinical trials help the public understand and have confidence in FDA’s science-based review process. FDA held another VRBPAC meeting on Dec. 17, 2020 to discuss the Moderna COVID-19 vaccine EUA submission.

The FDA’s evaluation of its COVID-19 work and response is ongoing. The FDA’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, initiated in April and announced in August, aims to apply best practices and lessons learned going forward, with transparency and strategic communication being key components. PREPP seeks to identify, design and support implementation of select programmatic, process, and organizational innovations that strengthen and accelerate the agency’s impact in COVID-19 response, recovery, and future crisis preparedness. The FDA continues to make real-time decisions using rapidly evolving data around COVID-19. To help address the ongoing public health issues related to the pandemic, the FDA is drawing on its experiences from prior health emergencies, such as Ebola and H1N1 influenza, as well as the successes of programmatic innovations across the agency, including the Oncology Center of Excellence’s Real-Time Oncology Review and Project Orbis pilot programs, to help inform our regulatory decision making as we address ongoing public health needs.

The strength of the FDA lies with its career scientists. Their decisions are driven by scientific evidence, data, and rationales, using objective information submitted for FDA’s review. As we continue our COVID-19 efforts, we will strive for additional clarity and transparency into FDA’s decisions. The robust public discussion of the Pfizer-BioNTech and the Moderna vaccine EUA applications at the recent VRBPAC meetings are a strong example of the agency’s commitment to an open and transparent review process that includes input from independent scientific and public health experts. As the FDA commissioner, I am personally committed to this, and know that the directors of FDA’s medical product centers join me in this commitment.

Hahn is Commissioner of the U.S. Food and Drug Administration.