Abstract

BackgroundThe Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.MethodsUsing HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in three time increments, < 1–20, 21–60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated.ResultsBetween 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs).ConclusionsFOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies’ FOIA programs might be made more efficient through greater proactive record disclosure.

Highlights

  • The Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research

  • At the Department of Health and Human Services (HHS), which has many constituent agencies, such as the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC), records subject to FOIA that might be helpful for advancing public health include aggregated billing records, medical product safety and efficacy data, abandoned New Drug Applications, and information related to research integrity [2,3,4]

  • FOIA request outcomes Between 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by CMS, 18.9% by FDA, and 11.6% by other HHS agencies (Table 1)

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Summary

Introduction

The Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. In the wake of the Times article, the NIH launched an internal review that found that interactions between NIAAA officials and alcohol industry biased the design of the study to demonstrate a beneficial health effect of moderate alcohol consumption, leading the NIH to terminate the study and to undertake a wider audit of industry influence on its research activities [5] In another example, a review of emails obtained under FOIA revealed that the Coca-Cola Company gained access to and influence with employees at the CDC and advanced corporate objectives, such as by downplaying the association between sugar-sweetened beverages and obesity [6]. In these and other examples, information accessed under FOIA has helped uncover undue influence on clinical research as well as on public health practitioners

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