Not so long ago, the Food and Drug Administration was completely cut off from patient voices.

Luckily, that's been changing in recent years, and in December, the agency upped the ante by creating the first-ever so-called FDA Patient Engagement Collaborative (PEC) to include patient advocate perspectives from a variety of disease states.

This is a joint effort with the Clinical Trials Transformation Initiative (CTTI), but don't let that group's name fool you -- this goes beyond clinical trials to create a channel for "patient engagement" on topics ranging from study design, to how technology or mobile health apps are developed, to the process of reviewing new products and evaluating their impact on users, to even how the agency communicates and tracks information.

“Patients are increasingly... spearheading the creation of novel registry platforms that collect health data to track their progress, and facilitate medical product evaluations. We’re fostering interactions with these patient-led registries to help them become vehicles for regulatory change," FDA Commissioner Scott Gottlieb wrote in a statement announcing this last year.

Cheers to the FDA! We like the sound of this, as how could it NOT be important to include more real-life perspectives from those who actually live with diabetes and other health conditions?

But just what are we talking about here?


The Patient Engagement Collaborative

Those invited to apply for the new PEC are people who either: have "personal disease experience"; are caregivers such as a parent, child, partner, family member or friend; or are representatives of a patient group with direct or indirect disease experience.

Some of the topics that may be on the table to talk about include:

  • making patient engagement more systematic
  • how to improve transparency
  • education and communication on the medical product regulatory process
  • new strategies for increasing patient input
  • new models for patients to collaborate as partners in the medical product development and FDA review process

This all stems from continuing efforts at the FDA to be more inclusive and do better for people in the healthcare universe, and this new collaborative is actually modeled after an initiative in Europe, know as the European Medicines Agency’s Patients’ and Consumers’ Working Party (PCWP), which assists in enhancing the organization’s relationships with patients. The US legislative framework allowing for this includes provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017 that aim to expand patient participation and incorporate patient experiences in the regulatory process.

Want to apply? You have four days left! The deadline to apply to become a member of the PEC is Jan. 29, as outlined in this Federal Register document and what the FDA's written about this collaborative effort.


Engaging with the Diabetes Community

The FDA has already made some great strides in connecting with our own Diabetes Community in recent years -- from a number of DOC webinars and online discussions (like that time our DOC Crashed the FDA Webinar Server!), to improving its efficiency in how it works to quickly approve devices, to FDA leaders embracing the #WeAreNotWaiting DIY community at our #DData events, and most recently launching an accelerated review program for mobile health tools.

In early 2017, the FDA began the process of creating a formal infrastructure for patient input by putting together what it calls a Patient Affairs Team, to interact specifically with those living with various health conditions. And then later last year, the agency created a Patient Engagement Advisory Committee made up of nine people who meet periodically to discuss topics such as agency guidance and policies, clinical trial design, patient preference studies, benefit-risk determinations, device labeling, unmet clinical needs, and other related issues on the regulatory front. The first meeting was in October 2017.

Bennet DunlapWell-known diabetes advocate Bennet Dunlap, a D-Dad of two T1s diagnosed as children and who lives with T2 himself, has been a member of that committee. While the FDA is cautious about how advisory committee members talk publicly about their work, Bennet was able to give us some general info about his experience so far.

“It was phenomenally surreal to be sitting on the other side of the ropes, being the ones listening to all the testimony" he says, adding: “We do have to realize that the FDA’s a big agency and, being that I like to use the big ship analogy, they don’t turn on a dime. We have to be patient, and understand that even as they’re trying to make the Venn diagram overlap more for patients, there’s not going to be 100% overlap because everyone does have their own mission.”

Overall, Bennet says he’s encouraged by the moves the FDA is taking to include more people. "The FDA is becoming, by intention, much more patient-centric. That’s fantastic."


Established + Grassroots Advocacy

Bennet says it was helpful sharing stories and hearing from those in other disease states, and recognizing what similarities and differences exist in what we’re all dealing with. He also thought it was helpful how the FDA advisory committee organized the room for the first meeting, having members grouped at smaller tables first where they could discuss and summarize thoughts before presenting them to the larger group.

It became clear to Bennet how fortunate we are to have strong national  advocacy and scientific orgs like the American Diabetes Association and JDRF, while many other disease states don’t have the like.

“To some extent, they’ve become a voice for the patient,” he says. “Maybe that’s not always appropriate, I don’t know. They are the voice of scientific research, in my view, more than voice of the patient, but they do bring patients to the Hill and into this process. Other disease states are trying to figure out how to emulate that.”

What our D-Community doesn’t have compared to others is training of grassroots advocates, Bennet noted. Some of the rare disease states have organized processes to help individuals get involved, bringing people up to speed to have one clear message, and teaching advocates how to get behind it. Our lack of that may be a result of less unity in our large and diverse community.

“In our community, there’s a joke slide about two ninjas parachuting out of a plane and trying to cut each other’s parachute cord. We do that between different types (of diabetes) and everyone arguing about what our priorities in advocacy should be… we’re all kind of slapping each other in the face; instead of a calm, 'let’s go get this done' approach, there’s a diversity of goals and that’s a two-edged sword.” 


Who 'Owns' Patient Engagement?

While all of this FDA change has been happening, it's been interesting to watch some of the online chatter questioning these "patient engagement" efforts -- not just by the FDA and government folk, but also advocacy organizations, industry, and healthcare providers.

We often see efforts to "include patients in the process" that never materialize into actual change; a handful of people are included as "token patients" seemingly more for show (to check a box) than with any tangible goals in mind.

And some folks complain it's not for "them" to use the language of engagement or push for it, but rather it should be driven by "us" -- those living with diabetes (or other health conditions).

That's an interesting philosophical quandary, but honestly any "Us vs. Them" situation tends to create silos and negativity. As Bennet says based on his FDA advisory experience, there's really a need to move toward an "Us WITH Them" mentality in order to improve the system.

We agree. Here's to working together with regulators, industry, medical professionals, advocacy orgs, and other health condition advocates to move the needle and get a more inclusive, efficient system.

From our perspective here at the 'Mine, mutual engagement is a very good thing.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.


This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.