FDA shares procedures for commenting at meetings

The Food & Drug Administration today issued procedural guidance on making public comments during the agency’s advisory committee meetings.

The Food & Drug Administration today finalized the draft for procedures that the public must follow to participate in the agency’s open meetings.

The watchdog agency holds open advisory committee meetings in an attempt to involve the public and representatives from the drug and medical device industry in its decision-making.

The new rules won’t become effective until March 2011 because “meetings typically take several months to plan,” the FDA said. The draft for the meeting procedures itself is now five years old.

The FDA’s new rules (PDF) include the following stipulations:

• 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 meetings, 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.