Assessment of Public Opinion on Transparency at the US Food and Drug Administration

Historically, the US Food and Drug Administration (FDA) has considered much of the oversight of clinical trials, interactions with companies, and review processes to be confidential.¹ In recent years, however, the agency has faced calls for greater transparency, including in its COVID-19 pandemic response² and use of expedited review pathways.³ To our knowledge, the views of the US public on transparency at the FDA have not been previously reported.

We conducted a nationally representative, cross-sectional survey of US adults from June 14 to July 2, 2021, in English and Spanish. The survey was based on a general population sample from the AmeriSpeak Panel of NORC (formerly known as the National Opinion Research Center) at the University of Chicago, which covers more than 97% of the US population.⁶ Participants provided informed consent to participate in the AmeriSpeaks panel, and the study was approved by the institutional review board of the Johns Hopkins Bloomberg School of Public Health. The study followed the American Association for Public Opinion Research (AAPOR) reporting guideline on the conduct of survey studies (eFigure 1 in the Supplement).

The survey assessed public opinion about 10 potential transparency measures and was developed to be generally understandable using a 2017 report⁴ and other recommendations⁵ as the foundation (Table 1). Using a 5-point Likert scale, survey participants could express their level of support (with 1 for strongly agree or 2 for somewhat agree) or opposition (with 5 as strongly disagree or 4 as somewhat disagree) (eFigure 2 in the Supplement).

We conducted subgroup analyses by sex, geographic region, race and ethnicity (which were self-reported in these categories: Asian or Pacific Islander [non-Hispanic], Black [non-Hispanic], Hispanic, White [non-Hispanic], and more than 2 [non-Hispanic] or other race and ethnicity), educational status, political ideology, and voting in the 2020 presidential election. After reviewing the data to identify a threshold for outliers, we identified subgroups whose views of FDA transparency differed from those of the rest of the US population by more than 15% in at least one-half of the measures. Statistical calculations were performed in R, version 3.6.0 (R Foundation for Statistical Computing).

A total of 4002 US adults were invited to participate, of whom 1035 (25.9%) completed the survey either online (n = 962) or by telephone (n = 73). The unweighted survey population had a mean (SD) age of 51.0 (17.1) years; included 476 men (46.0%) and 559 women (54.0%); and identified under Asian or Pacific Islander (19 [1.8%]), Black (94 [9.1%]), Hispanic (143 [13.8%]), White (730 [70.5%]), more than 2 (35 [3.4%]), or other (14 [1.4%]) race and ethnicity categories. The margin of error was ±4.28%. Study participants closely matched the demographic characteristics of US adults by age, race and ethnicity, sex, and educational status. The sample, compared with the general population, included a smaller proportion of people with higher household income (≥$125 000); 12.2% vs 27.1%) and with children (16.5% vs 32.5%).

Support for all transparency measures was high. Specifically, 86.2% of participants supported the disclosure of the reasons medications are not approved, 66.7% supported the release of basic information about medications in development, 77.6% supported the disclosure of the reasons clinical studies are placed on hold, and 77.2% supported the disclosure of the reasons studies are permitted to resume. There was strong support for the FDA disclosing basic information on pending applications for generic drugs (71.6%), explaining the reasons medications receive expedited review (80.5%), and sharing whether safety programs are working (83.2%). When asked whether the FDA should list medications that drug manufacturers have stopped developing, 67.6% of participants said yes, with 65.9% supporting the release of relevant FDA analyses. In addition, 90.7% of participants supported the FDA correcting the misleading information spread by drug manufacturers.

Support for FDA transparency exceeded opposition among participants from different sexes, races and ethnicities, geographic regions, and political ideologies (Table 2). Participants in 3 demographic groups expressed at least 15% less support for transparency than the rest of the population for at least half of the measures: those with less than a high school education (8 measures), those who did not vote in the 2020 election (7 measures), and those whose political party identification was “don’t lean, independent, or none” (5 measures). Less support was associated with increases in the neither-agree-nor-disagree response rather than opposition.

Amid the COVID-19 pandemic, which has been characterized by rancorous political division, there is broad support in the US population for greater transparency at the FDA. This support may reflect the interest of the public in understanding the drug development process and has implications for the ongoing pandemic response and beyond.

A limitation of this study is that, because the survey did not inquire about other possible transparency measures, there may be more or less public support for other ideas. Another limitation is that the survey did not seek to educate by providing arguments for or against transparency. The data reflect the initial reactions of the US public, which might change with additional information.

Accepted for Publication: December 29, 2021.

Published: February 18, 2022. doi:10.1001/jamanetworkopen.2022.0026

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2022 Azad TD et al. JAMA Network Open.

Corresponding Author: Joshua M. Sharfstein, MD, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, W1033F, Baltimore, MD 21205 (joshua.sharfstein@jhu.edu).

Author Contributions: Drs Azad and Sharfstein had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Azad, Sharfstein.

Drafting of the manuscript: Azad, Sharfstein.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Azad.

Obtained funding: Sharfstein.

Supervision: Gielen.

Conflict of Interest Disclosures: Dr Azad reported serving as a paid consultant for Acumen LLC outside the submitted work. Dr Sharfstein reported serving as Principal Deputy Commissioner for the US Food and Drug Administration from March 2009 to January 2011. No other disclosures were reported.

Funding/Support: This research was supported by Arnold Ventures.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.