The draft guidance now out for consultation would generally bar experts from participating in an advisory committee meeting if they had disqualifying financial interests with a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 (€37,430) in organisations 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, e.g. 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 The new draft guidance, which is open for comment until 21 May 2007, would replace the existing guidance on FDA Waiver Criteria published in 2000.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 organisation 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." A survey released by the Union of Concerned Scientists had found 28 per cent of FDA panel members disclosed financial conflicts of interest yet only 1 per cent excused themselves from advising on matters where there was potential for conflict. In September, a damning report on the FDA by the Institute of Medicine acknowledged that a zero-tolerance policy towards waivers was unrealistic but recommended that at least 60 per cent of advisory committee members should be free of any significant financial involvement with companies whose interests might be affected by the committee's deliberations. Waivers should be issued to other committee members only very sparingly, it added. 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. Legislation tabled in the House of Representatives by Democrat Maurice Hinchey sought a ban on the agency issuing any conflict-of-interest waivers to advisory committee members. Hinchey dismissed as "an empty claim" the FDA's assertion that without waivers there would not be enough suitable experts to make up its committees. The new draft guidance includes an algorithm for use in determining whether an expert should qualify for advisory committee membership. The various steps in the algorithm address questions such as whether the meeting is about a "particular" rather than a general matter; whether it will have a "direct and predictable" effect on the financial interests of the organisation(s) concerned; whether the candidate has held any financial interests within the preceding 12 months that would be a disqualifying financial interest if they were currently held; and whether the need for the individual's services outweighs the potential for conflict of interest. A "financial interest" is defined in the draft guidance as "the potential for gain or loss to the [government] employee (or persons/organisations whose interests are imputed to him) as a result of governmental action on the particular matter." The draft guidance was welcomed by critics of the FDA's conflict-of-interest policy including Representative Hinchey and consumer group Public Citizen. Representative Hinchey claimed the new approach was essentially "an endorsement of my efforts in Congress to prevent anyone with a financial conflict of interest from voting on an FDA advisory board." The Pharmaceutical Research and Manufacturers of America (PhRMA) kept its own counsel, though, saying it had just started reviewing the draft guidance and would respond in depth before the consultation deadline.
