Infusing Patient Perspectives Into Decision-Making: Recommendations for FDA

September 22, 2015

FasterCures Pull Quote3

As patient input becomes an increasingly hot commodity across the biomedical research ecosystem, momentum is building to find effective ways to unlock this resource and more meaningfully integrate patient perspectives into drug development and regulatory decision-making.

At FasterCures, we are keenly interested in identifying effective ways to enhance the science of patient input, and more systematically infuse patient perspective data across the full discovery, development, and delivery continuum. To that end, we have recently weighed in on several regulatory initiatives that we believe have the potential to create more patient-centric medical product development and drive better patient outcomes.

In July, FasterCures participated at both the Medical Device User Fee Amendments (MDUFA) and Prescription Drug User Fee Act (PDUFA) reauthorization public meetings. Our comments highlighted the importance of enhancing the science of patient input to ensure that patient perspectives can be effectively integrated into product development while also informing regulatory approval decisions.

Specifically, we encouraged the Food and Drug Administration (FDA) to:

  • ensure integration of patient perspectives throughout the drug and device development pipeline, from initial concept through post-market surveillance; 
  • maintain transparency to ensure that the outcomes of patient engagement are visible to the community; and
  • lay the groundwork to allow for appropriate, scalable, and sustainable analytical methods that will more effectively integrate patient perspectives into all aspects of medical product development and delivery.

In addition, last month we submitted comments on draft guidance FDA’s Center for Devices and Radiological Health released in May governing the submission and review of “patient preference information” (PPI) in applications seeking approval for certain medical devices. Although PPI is just one element of overall patient perspective information, this guidance represents an important step forward in clarifying how sponsors and regulators can use and evaluate patient-driven data.

There is still a lot of work to do to ensure that patient perspectives are elicited in a way that provides FDA with the evidence-based data it needs to make informed decisions, but early progress leaves us optimistic about the possibilities ahead. FasterCures continues to collaborate with stakeholders from all sectors to establish mechanisms that can help us achieve this goal, and looks forward to sharing updates in the months to come.


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