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The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: Proceedings of a Workshopin Brief
Pages 1-13

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From page 1...
... threats includ ing infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies."a • European Medicines Agency (EMA) : "Conditional Marketing Authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need." It "guarantees that the medicine meets rigorous EU standards for safety, efficacy and quality and that comprehensive data is still gener ated post-approval."b 1 21 USC Section 360bbb-3.
From page 2...
... However, she noted, "it raises fundamental issues about how to balance risks and benefits, urgency and scientific rigor, and how to navigate complex questions about the intersection of scientific expertise, value judgments, individual autonomy versus collective goods, political pressures, public accountability, and societal needs." As FDA Commissioner, Hamburg was involved with EUAs related to efforts to combat H1N1, Ebola, and Zika, but, she said, "none of those circumstances compare with COVID-19 in terms of the size, scope, urgency, or devastating impact, nor in all the other complexities swirling around."2 The EUA process began in the early 2000s in recognition of new "Our nation's experience with threats that had few FDA-approved medical countermeasures,3 Hamburg COVID-19 has highlighted the explained. The Project Bioshield Act of 2004 (PL 108-276)
From page 3...
... That based upon the totality of science evidence available, including available data from adequate and well-controlled clinical trials, it is reasonable to believe that the medical product "may be effective" to prevent, diagnose, or treat life-threatening diseases or conditions that can be caused by the agent; 3. The known and potential benefits of the product outweigh the known and potential risks of the product; and 4.
From page 4...
... Despite a surge of clinical trials globally, she noted few produced sufficient, actionable data and collective resources were not used efficiently for regulatory decisions. She observed, however, that master protocols have proven valuable in advancing pandemic responses.15 Cavazzoni noted that transparency is critical for instilling public confidence.
From page 5...
... Center for Devices and Radiological Health (CDRH) This is the seventh emergency in which EUAs were used for medical devices, said Shuren, but COVID-19 required a different playbook for a multitude of products including personal protective equipment (PPE)
From page 6...
... Noting the array of available devices and uses, Sharfstein asked whether other agencies might have helped guide FDA by defining use cases. Shuren agreed and replied that a national testing strategy could have determined which tests were needed, controlled distribution and supply of tests and testing supplies, and established mechanisms for reporting results.
From page 7...
... "The more we can anticipate and share, the better." Workshop planning committee chair Schultz asked about possible testingrelated changes. Becker called for a systems approach to bring stakeholders together.
From page 8...
... The reviews identified as challenges different guidelines among organizations, lack of preparedness, lack of transparency regarding the scientific basis for recommendations, and responses that exacerbated inequalities. Global health regulatory strengths include the health workforce, experience-based national responses, and vaccine development.
From page 9...
... ) explained that PAHO works with Latin American and Caribbean health regulatory authorities and procures medical products for those countries.
From page 10...
... Transparency could be Panelist Peter Lurie (Center for Science in the Public Interest) suggest- an important tool to reduce the ed that EUA criteria be revisited and clearer guidelines developed to strengthen uncertainty created by that flexFDA's evidence standard.
From page 11...
... He commented, "We need to think about adapting regulatory mechanisms to interdigitate with work happening in R&D to prepare for potential unknown future pathogens." "We should stop seeing our- Panelist Helen Rees (South African Health Products Regulatory Au selves as ring-fenced national thority) noted that COVID-19 called attention to the importance of regulatory entities and start seeing authorities, which are insufficiently supported in many countries.
From page 12...
... emphasized the need to make the emergency use authorization process work globally and to minimize discontinuity across regulatory environments. She cited FDA guidelines on vaccine approval as an example of clear communications that expedited industry's ability to participate in EUA while reducing uncertainty.
From page 13...
... The statements made are those of the individual workshop participants and do not necessarily represent the views of all participants, the planning committee, the Committee on Science, Technology, and Law, or the National Academies. REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop -- in Brief was reviewed by MARK MCCLELLAN, Duke University; ANALIA PORRÁS, Pan American Health Organization; and JOSHUA SHARFSTEIN, Johns Hopkins Bloomberg School of Public Health. MARILYN BAKER, National Academies of Sciences, Engineering, and Medicine, served as the review coordinator.


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