When it comes to conflicts of interest, the US Food and Drug Administration says appearances count.
For the first time, the agency issued on Tuesday a draft guidance spelling out circumstances when the appearance of a conflict of interest may preclude someone from serving on one of its expert advisory panels. Until now, the FDA had only circulated guidance for determining when an actual conflict exists.
The agency has been dogged periodically by concerns over conflicts of interest on its panels, which are also known as advisory committees. That’s because each panel is populated with medical and scientific experts who make crucial recommendations about whether a drug or device should be approved for use. And so, much is at stake for patients and the companies that make these products.
In response, the FDA implemented rules for participation, such as a $50,000 threshold for financial holdings in manufacturers whose products are effected by meetings, in a final guidance on conflicts issued in 2008. The agency now requires panel members to submit disclosure forms, although exceptions are allowed, such as when a sufficient number of needed experts are lacking, a move that briefly prompted the agency to consider relaxing the rules.
One watchdog says there have been fewer instances when financial conflicts have raised concerns recently, but welcomed the effort. “Appearances are almost as important as actual conflicts,” said Dr. Michael Carome of Public Citizen. “If there are multiple instances where there are appearance questions, it can have negative consequences and undermine public trust in the review process.”
Of course, the appearance of a conflict can be nuanced. So the guidance — which, unlike a regulation, is not binding — attempts to describe potentially problematic situations.
For instance, this might involve a panel member who has a relationship with a person or entity that is appearing before the panel. Examples might include a person with whom the panel members are or may be doing business; a person or entity for which the panel member has had a working relationship in the past year; or an organization in which the panel member is an active participant.
One hypothetical example found in the guidance: the panel member is dean of a medical school at a large university, which has a multiyear grant from the drug maker whose product is being reviewed at the meeting. Even though the grant is not related to the drug under review, the FDA writes “this is an interest or relationship that could cause a reasonable person to question the member’s impartiality.”
The notion of an appearance of a conflict can also extend to a relative or someone living in the same household as the panel member and has their own relationship with a person or entity appearing before the panel. The concept may also cover past financial conflicts, not just current conflicts, which is the litmus test that is currently used.
There may also be instances when an appearance is a hindrance, even if a current financial relationship does not warrant a recusal. One possible example is if a panel member has a current consulting contract with a drug maker whose product is being reviewed by the advisory committee, but the contract is not related to that particular product or issue being considered.
The draft guidance, however, does not address the appearance of another type of conflict due to what the agency has previously called “intellectual bias.” The phrase has been used to describe a situation in which a panel member who has a strong point of view about a medical product but appears unable to address the matter with an open mind. This sort of bias, however, may be harder to discern.
A infamous incident occurred in 2011 when the FDA removed Dr. Sid Wolfe, a senior adviser to Public Citizen, from an advisory committee prior to its review of birth control pills. He objected and was allowed to participate, but not vote. However, four other panel members had either done work for the companies that sold the pills or received research funding from them. And the FDA did not disclose their ties.