Impressions from the FDA panel on Unmet Patient Needs

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I was fortunate in being able to take part on November 3rd in a FDA panel on Unmet Patient Needs. I talked about this earlier and I know that many of you attended (or tried to attend). While there were technical difficulties, I was very pleased with the result. Below are my impressions.


I always thought of the FDA as being a closed off regulatory agency that just talked to industry, researchers and medical professionals, but that has changed. The FDA is now recognizing that it is important to hear the patient voice; the patient has a key role in defining effectiveness, safety and the context of risk and benefit. FDA representatives are really starting to get it, I really was particularly impressed with Helene Clayton-Jeter for championing the patient voice and Courtney Lias, Stayce Beck and Naomi Lowry who came across as not only extremely competent by really eager to hear from patients. I think these FDA representatives are perhaps the new guard who will lead important changes.

I was fortunate to sit on a panel with a number of other very prominent diabetes advocates where each of us was given an opportunity to share our stores and reveal a picture of what it is like to live with diabetes. We also had an opportunity to share things that are difficult in our lives because of diabetes. And through this we could share those things which should be considered during the FDA deliberations but have traditionally not been. Patients talked about quality of life, issues with hazards and side effects and the need to look beyond simplistic measures of effectiveness like A1c. The panel which consisted of 11 people was exactly on point, I don’t think I’ve seen nearly a dozen people take part in a 45 minute panel and be so clear.

I came away feeling like the FDA is listening patients, something I’m not sure I would have necessarily believed before seeing it. I think many of us as patients feel vulnerable at times. We aren’t always sure who is looking out for us and who is looking to make a buck. I came away feeling much better that the FDA has my back.

DiaTribe which helped organize the event has a great summary of the first phase of the panel and is working towards posting some record of the meeting as there were technical difficulties (I think the community may have overwhelmed the FDA webcast capabilities). To read about the the DiaTribe comment on the meeting and see the posted presentations of the meeting check out their overview. DiabetesMine has also posted a very nice summary of the meeting including comments from a number of the patient panelists (including me).


ps. And I really enjoyed having an opportunity to see Manny. We didn't have all that much time during the meeting to chat but we had a great time afterwards.

Additional Resources from the Meeting (courtesy of DiaTribe)

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Thanks, Brian. Putting a human face to our struggle is ket to gaining some influence in the FDA/Pharma/Patient triad. Pharma is all bottled up in confidentiality to a point of detriment to the patient.

I'd love to see an Elon Musk business type get involved in the diabetes pharma space. As principal of Tesla Motors he unilaterally surrendered all the Tesla patents to Chevy, Ford, Toyota, any competitor. He must reason that if the big car companies get behind electric cars then the economic pie will enlarge and provide Tesla with a bigger return.

All the secretive maneuvering that companies engage in, often with the FDA, makes me, the intended user feel like an afterthought. It's especially aggravating when a new design, like an infusion pump, comes out and they make design errors that show an obvious "diabetes blind spot."

I'm glad to hear your take on FDA sincerity.

I heard or read somewhere that you raised your statin story to the FDA. Good for you.

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It's very encouraging to hear that the FDA people are saying the right things. Now let's see whether all those good feelings and right sayings actually manifest as policies.

I forget who said it, but . . . "When words and actions disagree, believe actions." It will be most illuminating to see what actions result from this cordial discussion. Based on the long standing federal track record, I claim Missouri citizenship -- "show me". I hope they do. I really do.

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Brian, along with three more people, represented the T2D voice incredibly! I have posted some pictures of the day here:
http://www.tudiabetes.org/photo/albums/fda-panel-on-unmet-patient-needs-docasksfda