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# FDA Should Up Transparency to Gain Public Trust: Column
- URL: https://www.fdaweb.com/fda-should-up-transparency-to-gain-public-trust-column/
- Published: 2020-09-29T12:00:00.000Z
- Updated: 2026-09-14T16:30:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147763

Former FDA principal deputy commissioner **Joshua Sharfstein** and two other researchers say “FDA should look to increase transparency and maximize public trust in its integrity.” Writing in a *Stat* online opinion [column](https://www.statnews.com/2020/09/29/increase-transparency-at-the-fda-we-need-sunlight-to-fight-the-pandemic/?ref=fdaweb.com), the three offer four ways in which the agency could increase transparency.

They start their column by discussing the agency’s hydroxychloroquine and remdesivir emergency use authorization decisions and the lack of evidence supporting those decisions released to the public.

“Public confidence in FDA during the Covid-19 pandemic would be improved with greater transparency of the data and the reasoning on which it bases these and other complicated decisions,” Sharfstein and the others write. “The timely release of this information would promote trust in the agency throughout the process of clinical trials, review, and authorization and approval for Covid-19 therapies.”

They describe efforts made during Sharfstein’s tenure to improve transparency and additional recommendations from the Institute of Medicines. “Yet there has been little movement on these transparency initiatives,” they say.

The article points out that in 2018 former commissioner **Scott Gottlieb** started a pilot program to partner with manufacturers that volunteered to publish key clinical information contained in the clinical study reports of newly-approved drugs. The pilot ended 3/2020 after only one product sponsor volunteered to participate. “The agency simultaneously announced it had identified another way to disclose key information contained in clinical study reports,” the three say, “though this approach has yet to be implemented.”

Their recommendations for FDA to recommit to transparency, promote accountability, and safeguard public trust in the agency and its Covid-19 actions are: 

- release a public explanation within 10 days of FDA issuing or lifting clinical holds related to the safety or effectiveness of Covid-19 therapies in clinical trials;
- release information about Covid-19 products that do not merit authorization or approval;
- amend the guidance informing FDA’s power to issue emergency use authorizations during public health emergencies to include disclosure of the scientific basis of an authorization when it is issued; and
- make available pooled datasets on the development of Covid-19 therapies in masked and de-identified formats to qualified researchers through existing organizations involved in clinical data sharing.

The column says that one potential objection to the four proposals could be that they may involve disclosing what FDA has long considered to be confidential commercial information, and increased disclosures could be characterized as undermining a firm’s competitive advantages. The authors say that FDA can address manufacturers’ concerns by redacting details of memos relating to manufacturing practices or other business decisions, while still increasing disclosure of scientific insights that will advance researchers’ understanding of Covid-19.