The US Food and Drug Administration (FDA) has taken a number of steps to address long-running concerns about the independence of its advisory committees and the transparency of their procedures.
Among a raft of new measures that underline the agency’s efforts to restore its reputation as a guarantor of drug safety and efficacy in a hostile political climate, the FDA has issued two draft guidance documents dealing with voting procedures for its advisory panels and public disclosure of financial holdings that raise conflict-of-interest issues for committee members. Also published was a commissioned report highlighting “the difficulty of assembling highly qualified experts who are free of conflicts”.
The Draft Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings recommends that votes at committee meetings should be taken simultaneously rather than one after the other, “to avoid any potential order bias associated with sequential voting and thereby enhance the integrity and meaning of the voting results”.
The draft guidance discusses the risk of ‘momentum’ associated with sequential voting, whereby “some sequential voters may be influenced, perhaps even subconsciously, by the votes that precede theirs, especially if those votes are nearly identical or signal a clear trend”. The potential for influence “may be aggravated in the advisory committee setting, where votes are often conducted in full view of a passionate public and participatory audience”, the FDA suggests.
Further recommendations relate to the clarity and integrity of questions put to vote at advisory committee meetings, such as ensuring that a “robust” discussion involving all committee members is completed before the vote is taken, or that briefing materials supplied as background to committee members are thorough and pertinent.
Transparency and consistency
The FDA’s Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers sets out recommended changes aimed at improving the transparency and consistency of disclosure procedures for members’ financial holdings that create conflicts of interest. Under the proposed guidance, all advisory committee members would have to disclose publicly any financial interests for which a waiver had been granted.
The draft guidance also includes disclosure and waiver templates that have been redesigned to make them clearer and easier for the general public to understand. It stresses that the FDA already implements “a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimise any potential for conflicts of interest”. Moreover, it notes, in March the agency issued draft guidance proposing a “stringent” policy for considering eligibility for participation in advisory committee meetings where conflict-of-interest issues arise.
In addition to the draft guidance documents, the FDA has formalised operating procedures designed to “ensure appropriate security and promote proper decorum and public conduct” at advisory committee meetings. These are intended to guarantee that committee meetings “proceed in an orderly fashion and that the work of the committees is not impeded, but that the right of free speech is also protected”, the agency explains.
At the same time, the FDA’s web page on advisory committee meetings and processes at www.fda.gov/oc/advisory/default.htm has been overhauled to provide better access to information about waivers granted for conflicts of interest.
The agency also recently posted the names of outside experts appointed to a new risk communication advisory committee that will make recommendations to the FDA about how best to communicate the risks and benefits of FDA-regulated products (see www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html).
Necessary conflicts
The agency said the measures it had taken were consistent with recommendations made by the Institute of Medicine, which in a September 2006 report identified serious deficiencies in the FDA’s oversight of drug safety and claimed both the agency and the pharmaceutical industry had lost credibility because they “do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion”.
As before, however, the FDA has also argued for the necessity of granting conflict-of-interest waivers if it is to call on the best available expertise for advisory committee meetings. The aforementioned study commissioned by the agency from Eastern Research Group (ERG) looked at the relationship between expertise and financial conflict interests based on a sample of 16 recent advisory committee meetings.
The ERG report concluded that “the ability to create a conflict-free panel is speculative and that, even if possible, recruiting and screening costs would be much higher than current expenditures”. Moreover, the extra time needed to screen candidates “could significantly delay FDA decisions on major public health issues”, ERG warned.
Based on the overall expertise measures defined in the study, ERG found that standing advisory committee members with higher overall expertise ratings were more likely than other standing members to have been granted waivers for financial conflicts of interest.
