Expanded Access With COVID Therapeutics Were ‘Worst-Case Scenario’ For Informed Consent
High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
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Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.