FDA Guidance Document Development Process 

By Alvin J. Lorman, AAHP Counsel

The Food and Drug Administration (FDA) is seeking public comment on a draft “Report and Plan on Best Practices for Guidance.” Guidance documents, rather than rules, continue to play an ever-more important role in how FDA regulates industry. As such, the guidance document development process has attracted Congressional attention on several occasions. The draft report, mandated by Congress last year, is procedural in nature. It discussed how FDA uses and adopts guidance documents; it does not address any substantive scientific or legal issues. The Federal Register notice announcing the report is available here. The draft report is available here. FDA has requested comments by March 4, 2024. At this point, AAHP does not plan to submit comments.

In the Federal Register, FDA said that it is particularly interested in receiving comments on the following issues:

  1. The draft report summarizes FDA’s current best practices for the initiation, prioritization, development, review, clearance, and issuance of guidance documents that FDA has implemented in response to the 2011 [good guidance] report and other continual improvement efforts not described in the 2011 report. The draft report also proposes additional initiatives that FDA could consider to further improve its processes for the issuance of guidance documents. FDA solicits input on whether there are additional or revised practices, consistent with our statutory and regulatory framework, for the Agency to consider.
  2. Level 1 guidance documents are guidance documents that include initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues. Level 2 guidance documents describe existing practices or minor changes in interpretation or policy. Pursuant to FDA’s statutory and regulatory requirements, while the public may comment on a guidance document at any time, public participation is directly solicited prior to the implementation of Level 1 guidance documents unless we determine that such prior public participation is not feasible or appropriate. Issuing more guidance documents either as Level 1 guidance documents for immediate implementation, as FDA did during the COVID-19 PHE, or as Level 2 guidance documents would allow FDA to allocate its limited resources more efficiently, which would help FDA keep pace with rapid scientific developments and better serve the public health.
    1. In light of the above, we seek input on whether there are any additional circumstances, categories of guidance documents, or topics for guidance for which it may be appropriate and consistent with the FD&C Act and FDA’s GGP regulation for FDA to consider issuance as a Level 1 guidance document for immediate implementation without prior public comment.
    2. We also seek comment on whether there are additional categories or types of guidance documents that FDA should consider issuing as Level 2 guidance documents to streamline the guidance process and allow the Agency to better leverage its resources for the timely development of more guidance documents.
  3. FDA requests comment on any novel guidance document formats that would be of particular utility, such as use of templates to accompany a guidance document, Q&A formats, flowcharts, etc., that are used in FDA guidance documents or that were used in guidance documents issued in response to the COVID-19 PHE.
  4. FDA requests comment on the utility of guidances in streamlining regulatory submissions and whether there are additional categories or types of guidance that would be helpful to streamline processes for regulatory submissions to the Agency.
  5. FDA requests comments on whether the currently available mechanisms for submitting suggested areas for guidance development and proposed guidance documents are useful and sufficient or whether additional mechanisms, for example, a Center-specific or Office-specific mailbox for such suggestions would ease the process for such submissions.
  6. FDA Centers publish guidance agendas on their web pages to give interested parties and the public notice of the areas in which FDA is considering upcoming guidance. We request comment on the utility of these guidance agendas and what, if any, modifications to these agendas would be helpful for the Agency to consider.