Earlier today, FDA announced the availability of a draft guidance document “that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.” The new guidance document, once finalized, will replace a guidance document FDA issued February 2000 on how the Agency manages conflict of interest issues concerning special government employees who serve as advisory committee members, consultants, or experts to the Agency. The Federal Register notice announcing the guidance document will be published on March 23, 2007.
According to FDA, because of the complexity of the February 2000 guidance document “FDA officials found it difficult to achieve consistent results that the public could readily understand.” The new draft guidance document, however:
would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting. In addition to a more streamlined approach for considering who may participate in meetings, FDA would tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.
FDA’s issuance of the draft guidance is part of the Agency’s broader efforts to improve the advisory committee process. In February 2007, FDA issued a draft guidance document on the preparation and public availability of information given to advisory committee members. A third guidance document will reportedly address when conflict of interest waivers will be publicly released.