Transparency brings trust: Fda announces disclosure of review information used to support emergency use authorizations

The U.S. FDA issued a circular on November 17 promising to publicly disclose scientific data and other review information used to authorize, revise, or revoke the Authorization for Emergency Use of Drugs (EUA).
FDA Director Stephen Hahn said in a statement, "We recognize that the disclosure of information in the scientific review documents supporting the release, revision, or revocation of the EUA for pharmaceuticals and biological products, including vaccines, will help increase public confidence in the FDA's rigorous review of scientific data and the rational use of licensed products."
" Specifically, when CDER or CBER-regulated products are authorized for emergency use, or when a published EUA is revised or revoked, the FDA intends to disclose CDER and CBER's review of the scientific data and information supporting the decision to the extent appropriate and as permitted by law.
the FDA says the goal is to disclose the information in the EUA review documents where feasible, consistent with the FDA's long-standing practice of publishing scientific reviews after new drugs and biologics are approved.
added that certain information that is exempt from disclosure may be removed under the U.S. Freedom of Information Act (FOIA).
hahn said in a statement that each EUA is "data- and science-based" and that in emergency situations these ESAs are "unique and important public health tools."
" he also tried to explain more clearly the FDA's thinking about each EUA decision, and then described other measures aimed at increasing transparency, such as plans to convene an advisory committee meeting to review the COVID-19 vaccine candidate.
On the same day that the FDA announced this commitment, the U.S. Government Accountability Office (GAO) released a report that stated that the FDA had failed to "uniformly disclose scientific reviews of safety and effectiveness data for emergency use authorizations, as is the case with drugs subject to normal review procedures."
", the FDA has been widely criticized for its decision to treat the NEW Crown (COVID-19) treatment, the EUA, leading to an unprecedented lack of public confidence in the FDA.
The controversial EUA decision also raised more concerns about political pressure on the FDA, which was withdrawn three months later in March after U.S. President Donald Trump touted the use of chloroquine and hydroxychloroquine to treat the EUA for COVID-19 diseases.
COVID-19 Therapeutic Products Emergency Use Authorization Schedule (as of November 9, 2020) Herschel Nachlis, faculty of government studies drug regulation policy at Dartmouth College, USA, has previously written about the importance of FDA transparency in EUA decision-making for scientific decision-making, independence, and strictness in a competitive political environment.
Joshua Sharfstein, a professor in the Department of Health Policy and Management at Johns Hopkins University School of Public Health and a former deputy director of the FDA, welcomed the FDA's move, criticizing the agency for failing to advance its transparency program more comprehensively and for failing to explain decisions to approve or not approve a product more quickly and thoroughly.
"This is an important step toward transparency for the FDA," he said.
the public and the clinical community should understand not only the FDA's decisions, but also the reasons for them.
this challenging time, FDA transparency is critical to its own credibility and public trust.
the FDA's commitment today is a step in that direction, more important than anything else.
we have to look at how it's going, but I do think that's the right principle.
" borrows a phrase from Scott Gottlieb, former FDA director, "You earn public confidence in small drops and you lose it in buckets."
to win public trust by bit by bit, but when you lose it can be a bucket."
THE FDA's measures today are only the first step , and to restore damaged public trust , we need to be on the ground in the future to be independent , open and impartial in every matter of the day .