Policies that Bind? The Use of Guidance Documents by Federal Agencies

Each year, agencies issue thousands of pages of regulations through the notice and comment process. Given the extensive involvement of the federal government, the health and human services field is particularly affected by this kind of policymaking. Over the past decade, this process has drawn significant scholarly attention. However, policy creation via its close cousin—the agency guidance document development process—is largely unexplored within the fields of public administration and policy. Yet, over time, the utilization and importance of agency guidance has grown enormously. Indeed, in some areas, such as food and drug regulation, agency guidances are now the policy tool of choice for government regulators. This article provides an overview of agency guidance and its important role in the policymaking process. Additionally, it details an October 2019 U.S. presidential executive order on the subject, while also contextualizing the existing literature. The article then reviews select survey results drawn from a study of 41 U.S. Food and Drug Administration (FDA) regulations—20 of which were promulgated using the notice and comment process and 21 via the guidance process—to further illustrate the topic. The results imply a clear need for additional quantitative scholarship to better understand the political and policy underpinnings attached to regulating via agency guidance documents, particularly as they related to health and human services.