In a draft report and plan for guidance documents released by FDA earlier this year, the agency indicated that it intends to issue guidance documents without a public notice and comment period. The draft report is in response to a 2023 federal spending law that requires FDA to identify best practices for prioritization, development, issuance, and use of guidance documents.

“This is one of the more worrisome proposals we’ve seen from FDA,” said APC’s Tenille Davis. “The FDA staff is not all-knowing, and short of a national emergency, FDA needs to hear from stakeholders. That input can only serve to improve FDA guidance documents.”

According to FDA’s draft plan, the agency is considering issuing more Level 1 guidance documents for immediate implementation and categorizing more guidance documents as Level 2 — meaning more guidance documents would be implemented without a prior public comment period. 

The draft report received significant industry pushback, however — with some commenters indicating that this would open FDA up to legal challenges for failing to follow guidance regulation — so we’ll see if the agency moves forward with their plan. 

APC plans to raise the issue in its next listening session with the agency, set for May.