Today I heard back from a representative of the FDA about my concern and complaints surrounding the treatment of the public at FDA advisory committee meetings (my post of 11-20-07).

It was explained to me that at the time of the advisory committee meeting for Satraplatin when the public was relegated to the rear of the hearing room and only allowed to speak to the committee from the far side of the room there was a perceived security threat. The FDA representative cited post 9-11 concerns and also disclosed that certain committee members from prior meetings felt threatened. I was told the FDA hired an outside security firm to evaluate the security at the FDA as well as at the advisory committee meetings. The treatment of the community representatives was a direct result of the security recommendations received by the FDA.

During my conversation I was assured that, under normal circumstances, we would never experience a similar situation. I can only add that I hope this statement accurately reflects our future experiences.

I was also directed to additional information on the FDA’s web site that explains the FDA’s new operating procedures for public comment at the advisory committee meetings. I have included this below.

I do not have any objections to these guidelines however, how they get executed and how the public is actually treated in the future remains to be seen.

(from the FDA web site)
Public Conduct During FDA Advisory Committee Meetings

The FDA would like to ensure that advisory committee meetings proceed in an orderly fashion, are conducted in a safe and secure environment, that the right of free speech is protected, and that the ability of FDA Advisory Committees and Panels to accomplish their objectives is not disrupted. Therefore, the following procedures will be followed:

o An interested person who wishes to be assured of the right to make an oral presentation during the Open Public Hearing portion of an advisory committee meeting should register with FDA before the meeting. See 21 CFR 14.29(b). Those who have not registered before the meeting will only be invited to speak at the discretion of the Chair, and should submit their request to FDA officials at the registration desk on the day of the meeting.

o Open Public Hearing participants who are designated to speak may be questioned only by the Chair or other members of the Committee.

o Audience members may not present comments or questions to the Committee unless recognized by the Chair.

o Attendees may be subject to security screening, such as presenting identification, passing through metal detectors, and inspection of briefcases, packages, etc.

o Attendees at the meeting are asked to maintain order and not display behavior that is disruptive to the meeting (i.e., shouting from the audience, loud outbursts).

o The committee Chair or Designated Federal Official will note on the record any disruptive behavior and will ask the person to cease the behavior or else leave the meeting room.

o We ask that attendees not approach the advisory committee table area before, during, or after the meeting without permission from a Designated Federal Official/Executive Secretary.

For Immediate Release: Nov. 15, 2007
Media Inquiries: Christopher DiFrancesco, 301-827-6242,
Consumer Inquiries: 888-INFO-FDA

Joel T. Nowak MA, MSW