The draft guidance now out for consultation would generally bar experts from participating in an advisory committee meeting if they had disqualifying financial interests with a combined value of more than $50,000 in organizations that could be affected by the committee's discussions.

Experts with disqualifying financial interests of $50,000 or less would be eligible to participate only if they satisfied the statutory waiver conditions on conflict of interest, such as if the need for the person's services outweighed the potential for conflict of interest. Even in those circumstances, the expert's participation would be restricted to a non-voting role.

Moreover, the FDA intends as a rule to "limit participation in certain cases where there may be a perception of a conflict of interest, even though full participation would be permitted under the applicable statutes."

The new draft guidance, which is open for comment until 21 May 2007, would replace the existing guidance on FDA Waiver Criteria published in 2000. This document includes a series of tables indicating the expert's involvement level in the organization that might be affected by the meeting, as well as the expected action by advisory committee staff.

The tables are subject to a number of other variables, such as the nature of the expert's interest (e.g. stocks and investments, consulting work) and the type of meeting at hand (i.e. involving specific parties or issues of general concern).

The Waiver Criteria 2000 guidance was "an attempt to address comprehensively the multiple variables that can be applied in reaching a determination about an individual advisory committee member," the FDA noted. "However, because of its complexity and discretionary elements, Centers and offices found it difficult to achieve consistent results that the public could readily understand."

The aim of the new guidance is to simplify and streamline these procedures while addressing criticisms that the FDA's waiver policy for advisory committee members has been inconsistent or lax. The agency is "committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees," stated Dr Randall Lutter, the FDA's acting deputy commissioner for policy. He told reporters that a "significant" proportion of advisory committee members were likely to be affected by the revised conditions for membership.

The FDA said last July it was developing guidance "to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest" and was making "additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency's advisory committees."

Some FDA officials have argued, along with the pharmaceutical industry, that excluding experts on account of their private sector work would take away the agency's flexibility to secure the best-quality scientific advice. However, the FDA has also come under pressure from Congress to clean up its act.