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1117 EUA transparency
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Regulation

FDA to post data on COVID-19 therapeutic, vaccine EUAs

Nov 17, 2020 | 10:19 PM GMT

Responding to public criticism of some of its COVID-19 emergency use authorization decisions, as well as a recommendation from a government watchdog agency, FDA announced Tuesday that it will publicly post reviews of the scientific data and information supporting regulatory decisions about EUAs of COVID-19 therapeutics and biologics, including vaccines.

The decision is consistent with a recommendation the Government Accountability Office (GAO) made in a report released Tuesday.

GAO stated that while FDA has released authorization letters and some other data on EUAs, “the evidence to support FDA’s authorization decisions has not always been transparent. This is because FDA has not uniformly disclosed to the public information from its scientific review of each therapeutic’s safety and effectiveness data, at the time of its authorization.”

FDA has issued EUAs for four COVID-19 therapies: chloroquine and hydroxychloroquine; Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD); COVID-19 convalescent plasma; and bamlanivimab from Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc. FDA subsequently revoked the chloroquine and hydroxychloroquine EUA.

Data released about the COVID-19 therapeutic EUAs has been inconsistent, GAO noted. For example, while the agency released a clinical decision memo detailing preclinical and clinical data along with the EUA for convalescent plasma, it “did not release decision memos with the chloroquine and hydroxychloroquine, remdesivir, or bamlanivimab authorization letters.”

GAO also observed that “there has been considerable variation in the type and amount of data and information FDA cited in its authorization letters and available supporting documentation, compounding the lack of transparency surrounding the evidence supporting FDA’s EUA decisions.”

GAO recommended that the HHS secretary “direct the FDA Commissioner to identify ways to uniformly disclose to the public the information from FDA’s scientific review of safety and effectiveness data — similar to the public disclosure of the summary safety and effectiveness data supporting the approval of new drugs and biologics — when issuing EUAs for therapeutics and vaccines, and, if necessary, seek the authority to publicly disclose such information.”

In its formal response to GAO’s report, HHS acknowledged the importance of transparency but did not commit to take any specific action.

The announcement Tuesday, however, hews closely to the GAO recommendation.

In a statement, FDA Commissioner Stephen Hahn wrote 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.”

Former FDA officials told BioCentury the transparency measures will help enhance confidence in its decisions. “It’s great to see FDA moving in the direction of more transparency,” Joshua Sharfstein, vice dean for public health at the Johns Hopkins Bloomberg School of Public Health and former FDA principal deputy commissioner, told BioCentury. “Explaining the basis of the agency’s decisions will help build credibility and trust.”

Jesse Goodman, former director of FDA’s Center for Biologics Research and Evaluation and former FDA chief scientist, told BioCentury that “for coronavirus EUAs, sharing the underlying data as well as FDA’s reviews and rationale in its decision-making would be a positive step in enhancing transparency and confidence.” Goodman is a Georgetown University professor and director of the university’s Center on Medical Product Access, Safety and Stewardship (COMPASS).

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