FDA builds higher walls between advisors, industry

The guidance, which is expected to come into effect within 120 days and formalises a draft policy drawn up in 2007, would set a cap of $50,000 “as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting​,” such as a company or competitor whose product is under review.

The aim is to reduce any real or perceived risk that the objectivity of an advisory committee could be compromised by a panellist with a conflict of interest, according to the agency.

The FDA relies on external experts to help it make decisions on complex medical and scientific issues, so aside from what will doubtless be endless debate about the appropriateness of the $50,000 threshold itself, the big question is whether this new will prevent impropriety among panellists but still allow the best expertise to be included.

Recognising this, the guidance also includes a waiver system. This means that FDA staffers can elect to allow a panel member with a smaller financial stake to take part, provided FDA officials “determine that there is an essential need for the advisor’s particular expertise​.” There are still exclusion criteria however – for example the principal investigator in a sponsor clinical trial would be barred.

The waivers would also be posted on the FDA’s website ahead of the meeting and include a description of the panellist’s interest and why his or her attendance was deemed necessary. It will also impose a limit on the number of waivers issued.

Critics have suggested that the agency should have stuck to original proposals to allow panellists with a lesser financial stake to attend but not to vote.

Conflict of interest has been a central part of the FDA reform process in recent years, with accusations often levelled that current waivers and notification procedures are simply not working.

There is some evidence to back that up. In 2006, for example, the Journal of the American Medical Association published a study which analysed 221 meetings and found that “conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members​.”

However, that study also concluded that there was only a weak effect on the outcome of meetings. In other words, the conflicts of interest did not appear to be swaying the votes cast.

There have been suggestions that the funding for the FDA should be hiked to remove its reliance on external advisors entirely, but many observers believe this is simply not a workable solution as it is very likely that the best experts in any field will not be employed by the regulatory body.

What is clear is that for now the agency cannot do without its advisors. Last year alone it relied on their input for 48 advisory committee meetings, on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children.

Other reforms include the publication of FDA briefing documents at least 48 hours in advance of the meetings, and a ban on sequential voting. Now all panellists will vote simultaneously to avoid any risk of ‘voting momentum’, in which some voters may be influenced, even subconsciously, by the votes of those who precede them.