The Food and Drug Administration is putting together a patient engagement advisory committee, comprised of 9 voting patient representative members (yet to be chosen), who will concentrate on the patient perspective in a much more specific way than what’s previously been in practice.
This ideally will help guide regulatory decision-making, primarily in regard to opinions on self-reported benefits and risks.
With this committee development, the FDA is now putting a direct effort into incorporating patient viewpoints systematically into decision making, according to Kathryn O’Callaghan, Acting Associate Director for Science and Strategic Partnerships in FDA’s Center for Devices.
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This isn’t an entirely new initiative, necessarily. The FDA has put effort into patient reach-out previously, but this will be a continued effort on that front.
The administration is approaching the input both from a population-wide, research and study aspect, in addition to having individual patient input within the committee discussions.
Earlier this year, the FDA explored how direct input could have a strong impact with feedback regarding patients’ risk-benefit preferences addressing obesity because of it’s a very prominent public health issue and there are various options for treatment – anything from exercise and diet to surgery. The goal, according to O’Callaghan, was to get robust, granular data on patient viewpoints. Basically – is it actually worth the risk to undergo surgery or device implantation for patients when they are addressing that particular health issue.
The data received from the obesity study reportedly provided a good framework in order for the FDA to move forward and put together trials that more accurately reflect what patients want and how they feel about options involving devices up for approval.
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Part of the impact this advisory committee could have might go beyond just making decisions about what the FDA does and does not approve – it also could be a source of information for device makers in order to ideally develop better products.
As much as the patient perspective is becoming increasingly important, there is still a line when it comes to a collective standpoint and one of authority.
“We understand that patients expect us to do our jobs,” O’Callaghan said. “They don’t want to make a decision for us. We have a lot of scientists with medical expertise, and that’s necessary for us to evaluate these technologies and evidence that comes out of regulatory evaluation processes.”
But O’Callaghan highlighted the fact that this committee has been designed to essentially fill out the edges of a structured operation that really has had the patient in mind from the start.
“I think of it [patient involvement] as the framing around the evidence we’re looking at – to put it in context,” O’Callaghan said.
