FDA issues reports on best practices for communication, guidance development

The US Food and Drug Administration (FDA) has issued two reports detailing its actions and plans for best practices for communication with interested parties and for issuing guidance documents. The agency’s thinking in both areas was influenced by its actions during the COVID-19 pandemic, and both reports were mandated by Congress in the Consolidated Appropriations Act of 2023.

Communication best practices

In its report on communications best practices, FDA details how it has traditionally interacted with stakeholders, such as through its website at FDA.gov, meetings, webinars, guidance, and more. The COVID-19 pandemic prompted the agency to look to more rapid, innovative communications methods as part of its public health emergency (PHE) response.

“The COVID-19 PHE touched nearly all industries regulated by FDA, and it necessitated nearly around-the-clock communications as FDA sought to address the breadth of pandemic-related impacts,” said FDA. “FDA communications addressed such disparate topics as, for instance, how FDA was working to mitigate supply chain disruptions (such as for personal protective equipment, other medical devices, pharmaceuticals, food and other commodities); information for medical product sponsors seeking to develop and distribute medical countermeasures; procedures for sponsors and others seeking to engage with FDA regulators through entirely remote interactions; and much more.”

“To handle the scope and volume of communications needs, FDA established new tools and increased use of existing methods to reach industry audiences through multiple channels,” the agency added.

FDA has proposed five action items to improve its communications using those tools and methods developed during the pandemic, including incorporating recommendations from an October 2023 Reagan-Udall Foundation report, Strategies for Improving Public Understanding of FDA Regulated Products. The agency said it is reviewing the document before it adopts the recommendations.

FDA said it is also exploring ways to enhance its website to further help with regulatory submissions.

“For instance, FDA is considering ways to improve the utility of information related to guidance documents, technical specification documents, fact sheets, Q&A documents, and webinars,” said the agency. “FDA also plans to explore mechanisms to increase accessibility and diversity in its communications to facilitate broader engagement by interested or affected parties, including regulated industry.”

FDA also plans to explore new partnerships with intra-agency and external stakeholders to promote its webinars on guidances and other topics further and reach a wider audience. The agency also said that as part of its Information Technology Strategy for FY 2024 – FY 2027, it is creating a “Shared OneFDA Ecosystem,” which is intended to promote a culture of sharing information with external stakeholders where appropriate.

Finally, FDA is proposing to increase its language communications services to reach a broader audience.

"FDA’s multilingual communications services help the Agency better serve diverse communities within the United States, including people with limited English proficiency; connect with entities outside of the United States; and meet language access requirements, such as requirements under Executive Order 13166: Improving Access to Services for Persons with Limited English Proficiency," said the agency.

Stakeholders can comment on the proposed communication best practices report on www.regulations.gov under docket no. FDA-2024-N-4821 until 1 February.

Final report on guidance best practices

In its final report on guidance best practices, FDA explains how it plans to improve the development and communication of new guidances. The agency published a draft version of the report in December 2023 and opened a 60-day comment period to get stakeholder feedback.

In 2011, FDA published a report on good guidance practices that included recommendations to streamline guidance development, reduce the time it takes to publish a final guidance from its draft version, and improve access to guidances on its website.

FDA said several stakeholders asked the agency to standardize its guidance templates further across centers and offices to ensure consistency. However, the agency argues that its centers and offices address a broad range of topics for a wide audience, making it inappropriate to use a single template.

“However, FDA agrees that having more consistency in the format of our guidance documents is a best practice for drafting guidance documents,” said the agency. “FDA intends to review the templates currently used to determine whether and how existing templates might be revised to provide some additional consistency in the visual format of our guidance documents across FDA Centers and Offices.”

Some commenters also asked FDA to expand the use of guidances such as those in Q&A or bulleted format, arguing they are easier for the lay public to understand and easier to revise. The agency also got feedback to use more visual elements such as flowcharts, real-life examples, and hypothetical scenarios in their guidances to clarify concepts, roles and responsibilities, and also use references to applicable laws and other documents.

“FDA agrees that use of such features in appropriate circumstances is a best practice to improve the readability and utility of guidance documents; FDA currently uses many of these suggested tools and intends to continue to seek opportunities for their use, as appropriate for the intended audience and subject matter of the guidance,” said FDA in response. “FDA intends to also continue to provide citations to relevant statutes, regulations, and related guidance in its guidance documents.”

“With regard to providing references with links to applicable laws and other relevant guidance documents, FDA notes many of our Centers and Offices already provide these resources on their web pages,” the agency added. “As FDA undertakes a review of its guidance templates and internal procedures, FDA intends to incorporate these suggestions to encourage use by each Center or Office if appropriate to the particular guidance being developed.”

FDA delved into other important areas in the report, such as how to improve guidance communication. The agency said it would continue to evaluate whether to hold town hall meetings and webinars to discuss especially complex guidance issues depending on the availability of its resources.

FDA said it also plans to create an updated FDA Guidance web page to house general background information about its guidances, include links to other guidance-related web pages, and clearly indicate how to get notified of newly issued guidance documents.

Draft communications best practices report

Final guidance development best practices report

FDA issues reports on best practices for communication, guidance development

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