Regulatory Focus™ > News Articles > FDA Re-Issues Final Guidance on Open Public Hearings, Following Unusual Process

FDA Re-Issues Final Guidance on Open Public Hearings, Following Unusual Process

Posted 04 June 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new final guidance document regarding open public hearing sessions at the agency's advisory committee meetings, but the process by which it was published is highly unusual under the agency's good guidance practice standards.

Background

The final guidance, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings, was first issued as a draft guidance in 2005, and was seemingly finalized in December 2010.

At the time of its 2010 finalization, FDA indicated that the guidance would better inform the public on how to request speaking time at the advisory committee meetings, and provide further guidance to FDA staff on how to accommodate and respond to those requests. Advisory committee meetings are non-binding meetings, usually of subject matter experts, who identify potential issues in either a product submission or a general regulatory problem and make a non-binding recommendation to FDA.

FDA's 2010 guidance included six main points, along with a laundry list of others:

  • The public may request, either orally or in writing, to speak at a meeting. FDA said it is in the practice of allotting 5-10 minutes per person.
  • FDA may decline the request if it is "unrelated to the committee's work."
  • If given time to speak, a person should identify themselves and make all presentation materials available to the committee members. Those materials will be made a part of the public record.
  • Members of the advisory committee are encouraged to ask questions of the speakers but advised to treat them with respect.
  • Public speakers should divulge potential financial conflicts of interest.
  • FDA will provide designated seating for public speakers.

FDA added that the guidance was to be effective as of March 2011.

Unusual Process

It is perhaps curious then that the agency has updated the guidance document once again, releasing another edition of the "final guidance" on 3 June 2013. Unlike its predecessor, the document, dated 15 May 2013, was not made available in the Federal Register. 

Under FDA's Good Guidance Policies, "minor changes in interpretation or policy" in a guidance would permit its re-release as a Level 2 guidance document, but the agency is supposed to invite comment on the guidance. FDA is most generally in the practice of doing so through the Federal Register or the Federal Docket, FDA's docket for the old announcement, FDA-2005-D-0072, does not contain any mention of the new final guidance. A search through the rest of FDA's federal docket did not find any mention of the new guidance either.

In a call to FDA's Michael Ortwerth, a supervisor within the Office of Special Medical Programs (OSMP), Ortwerth explained to Regulatory Focus that the agency had only made several minor changes to the guidance, those being reference-based changes regarding the FDA Amendments Act (FDAAA) and a brief discussion about the time allotted to each speaker.

FDA's legal staff determined that the changes did not require the guidance to be re-published in the Federal Register or Federal Docket, he added.

The updated final guidance may be found here.


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