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The Food and Drug Administration today announced several improved policies and procedures to strengthen its management of FDA advisory committees. They are detailed in four final guidance documents and one draft guidance outlined below. Our goal is to make the our process for seeking advice from independent experts as open, public, and transparent as possible, so that we maintain the highest public confidence in that process.
Final Guidance on Procedures For Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
This guidance describes how FDA will determine whether an individual invited to participate in an FDA advisory committee has a potential conflict of interest and, accordingly, whether he or she is eligible to participate in an advisory committee meeting. FDA has for many years screened prospective advisory committee participants to determine whether the potential for a financial conflict of interest exists. When an advisor has a potential conflict, FDA may grant a waiver to allow participation.
The approach set forth in FDA's guidance makes the agency's review of potential conflicts more stringent than the legal requirements recently put in place by Congress. It is more stringent than FDA's Waiver Criteria 2000 guidance in four ways:
The guidance will improve consistency in the agency's handling of potential conflicts of interest and provide greater clarity to the public.
This guidance will ensure that when FDA grants a waiver, the circumstances of that waiver will be made clear and transparent to the public. All waivers and advisors' disclosures of potentially conflicting interests will be posted to the FDA web site. In most cases, FDA will post these documents at least 15 days prior to the relevant advisory committee meeting. New templates for waivers and financial interest disclosure will make them clearer and more consistent. These changes will make the basis for FDA’s decision to grant a waiver clearer to the public.
This guidance is intended to ensure integrity of the voting process at advisory committee meetings. It recommends that any question put to a vote be clearly and collectively understood by those voting, and it urges that there be a robust discussion of the issues at the heart of the question before voting takes place. The guidance also recommends that votes be cast simultaneously rather than sequentially. This is intended to avoid "voting momentum," in which voters may be influenced, even subconsciously, by the votes of those who precede them.
This guidance is intended to help sponsors develop, prepare and submit to FDA briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. It sets out timelines for preparing and submitting the briefing materials to FDA. The guidance also describes when FDA intends to make the briefing materials available to the public.
As described in the guidance, FDA intends to notify a sponsor about an open meeting that will involve its product approximately 55 business days before the meeting. The guidance then includes information on how to prepare its briefing materials, and sets out timelines for the submission, review, and public availability of the briefing materials. The timelines vary depending on whether the sponsor's briefing materials may include information that, under certain circumstances, could be considered to be exempt from public disclosure, or whether the sponsor is stating that its briefing materials are fully releasable to the public.
The guidance states that FDA intends to post the publicly available version of the briefing materials on its web site no later than two full business days before the day the meeting is scheduled to occur.
This draft guidance proposes to clarify when FDA should refer a matter to an advisory committee. It is being issued for consideration and public comment.
In some instances, FDA is required by law to refer an issue to an advisory committee. In others, it has discretion to consider whether to refer a matter to an advisory committee. The guidance proposes that FDA consider three factors when deciding whether to voluntarily refer a matter to an advisory committee. It proposes that when one of these factors is met, FDA should refer the matter to an advisory committee. Conversely, if none of the factors is met, FDA should not refer the matter.
The guidance also proposes that, for all first-of-a-kind or first-in-class products for human use, FDA either refer the product to an advisory committee or provide in the action letter for that product a summary of the reasons why it did not refer the product to an advisory committee before approval.
FDA has enhanced the transparency of its advisory committee program by overhauling its advisory committee Web site. We began by engaging various stakeholder groups -- including consumers, patients, health care professionals, and industry representatives -- to help us assess the Web site's strengths and weaknesses.
Based on this assessment, we redesigned the Web site and streamlined access to the information that appears to be of greatest interest to users. We then performed usability testing to evaluate the changes and to further refine our improvements.
The most significant improvements include the following: