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Alliance Discussion with Randall Rutta: The National Health Council’s Vision for Patient Centricity

In a July 27, 2022, alliance discussion, Randall (Randy) Rutta, Chief Executive Officer of the National Health Council (NHC), discussed his work with NHC, the organization’s vision for patient centricity, the future of the Prescription Drug User Fee Acts (PDUFA), and how advocates can advance the goal of maximum patient engagement. Some of Rutta’s insights:

On “meaningful patient engagement”:  

“We’ve heard [meaningful patient engagement] referred to as direct relationships and partnerships that are bi-directional, reciprocal, and continuous. That truly embracing the patient and the lived experience they have – their dreams and aspirations not just for their health, but for their life – is what we take into consideration by inviting them to share and help make these decisions.” 

On the current status of PDUFA reauthorization: 

“PDUFA reauthorization is currently in front of Congress, and we’re pleased that the FDA has indicated to Congress that they’re very supportive of moving forward with many of the recommendations that have come from the patient community. [These recommendations include]: conducting demonstration projects, including engagement with stakeholders such as patient organizations; convening a series of public meetings or workshops with key stakeholders, including patients; and establishing a cross-center committee with the role of engaging stakeholders.”  


“PDUFA VI includes a commitment from the FDA to develop a series of four guidances: collecting comprehensive and representative input; methods for identifying what’s important to patients; selecting, developing, or modifying fit-for-purpose clinical outcome assessments; and incorporating clinical outcome assessments into endpoints for regulatory decision making. The NHC was really pleased with the first two guidances, and they really laid the groundwork for the final two.”  

On ensuring diversity in clinical trials: 

“We are very interested in clinical trials, along with our partners and the FDA, and making sure that clinical trials represent the diversity of the patient population. Many of our clinical trial sponsors have been working to be more and more inclusive and represent that diversity in their trials. Certainly, patient groups have a role to play in helping these sponsors locate patients who would demonstrate the level of diversity that we’re looking for.”  

On health care professionals and patient engagement: 

“By virtue of the training, [health care professionals] aren’t being taught how to engage patients. We’ve got the tools now though, so we just need to be the conduit in helping them [learn to] use those tools, and later it becomes natural… when they are involving patients… with whatever they are trying to accomplish in their role, they’re going to have a better outcome”.