The U.S. Food and Drug Administration today issued final guidance for people who wish to comment during the agency's advisory committee meetings. The guidance provides instructions on how to request a time to speak and how FDA staff should respond to requests to speak at the meetings.
The FDA encourages participation from all stakeholders in its decision-making process. Every advisory committee meeting includes an open public hearing session, during which interested people may present relevant information or their oral and/or written views.
The guidance finalizes information contained in the 2005 draft guidance titled The Open Public Hearing - FDA Advisory Committee Meetings - Draft Guidance.
Highlights of the guidance include:
• Before an advisory committee meeting, people may ask, either orally or in writing, to speak at the meeting; they should include contact information, topic to discuss, time requested; FDA usually allots 5-10 minutes per person.
- FDA staff responds to requests and, if the topic is unrelated to the committee's work, may decline the request.
- At the meeting, speakers should identify themselves to FDA staff and provide any handouts or other materials, which staff then provides to committee members. These materials then become part of the meeting's permanent record.
- Committee members are encouraged to ask questions of the speakers, to discover more information that might be useful to the committee's deliberations. Committee members and the public should be reminded of the importance of the open public hearing session and that all speakers should be treated with courtesy and respect.
- Public speakers are encouraged to disclose any financial relationships they may have with the topic of the meeting or with sponsors of competitors of the products under discussion.
- FDA will provide a designated seating area for speakers.
Since meetings typically take several months to plan, we are implementing the new guidance starting with meetings held in March 2011.
Advisory committees enhance the FDA's ability to protect and promote public health by ensuring FDA has access to comments from the public through the public hearing process provided in existing laws and regulations.
Each advisory committee meeting includes a comment period during which members of the public; individuals or spokespersons from the regulated industry (except the sponsor whose product is under review); consumer advocacy groups; and professional organizations, societies, or organizations are invited to speak.