Talking with the FDA.

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When I first discovered the group of bloggers, reporters, healthcare professionals, and patient advocates that make up the Diabetes Online Community, I remember feeling really good about the support and encouragement I was suddenly finding through the internet.

I did not know much about the U.S. Food and Drug Administration, other than knowing that they had to approve every new drug or device used to help me survive with diabetes. Then I started reading a lot from people who felt that the FDA was holding back progress on these things. How the FDA never took the patient point of view into consideration. How they were a bottleneck, holding back advancement toward better outcomes for us.

Well, I’m not sure if that was entirely true then. But I do know now that it is not true today.

Last year, Strip Safely helped lead a campaign to get more people to comment on FDA draft guidance for glucose meters. We were all encouraged to post comments letting the FDA know how important greater accuracy and post-market inspection is when considering the trustworthiness of new glucose meters and test strips.

We were able to post those comments directly to the FDA because they made it possible to do so, easily, online. As a result of just that one push to comment, the FDA received six hundred comments on this one issue. That’s about six or seven times the number of comments they generally receive on draft guidance. Collectively, and as individuals, the diabetes community spoke and the FDA listened. But that’s not all.

A few weeks ago, I received an e-mail from the Food and Drug Administration about comments I left regarding glucose meters in a point-of-care setting (hospitals, doctor’s offices, etc.). They wanted to speak to me about what I had written them. So we scheduled a time, and I spoke by telephone with Katherine Serrano, Deputy Director of the FDA’s Division of Chemistry and Toxicology Devices.

We talked about some of the things I had written, and she had a few questions for me. The thought of that seems a little intimidating at first. But rather than just a talk between a Deputy Director at FDA and a guy from Baltimore, it was really a conversation between two people discussing an important topic. I tried to give her my passionate best on the subject, and she remained engaged, asking follow-up questions and allowing me to consider her questions carefully before answering, and even letting me e-mail her later with additional feedback. This does not seem like the actions of a group that does not care what we think.

I don’t know how seriously Ms. Serrano or the FDA considers my views on the subject. But there’s no denying the fact that I was given not one, but two chances to deliver a personal plea for the best possible device guidance on point-of-care glucose monitoring. And I was not going to pass on either one of those opportunities.

Because new innovations often take years to get into the hands of the people who need them most, it’s easy to feel like your voice would get lost among the masses, even when you do take the time to respond to something. But what’s the alternative? You, or people you love, are the patients, the ones most affected by any changes to the status quo. The one way to be sure your concerns are part of the public record is to make them public. The one way to help all people with diabetes get the better outcomes they deserve is to insert your voice into the conversation. And if you’re asked for additional perspective, be sure to speak with the passionate desire for the absolute best results that comes with the perspective that only you possess.

We’re counting on you. Allow yourself to be the voice that makes the difference.

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  • Laddie  On September 19, 2014 at 7:00 pm

    You must have made a good comment to get contacted and I am more than happy to have you be one of the voices representing me. I suspect that my comments weren’t very inspired…. It is great to see some communication with the FDA but I am still incredibly frustrated that we get medical devices 2-5 years after Europe.


    • StephenS  On September 20, 2014 at 12:03 am

      Laddie, my comments were a combo of what was suggested on the Strip Safely website and my own feelings on the subject.

      Regarding your frustration, I completely understand. My only frame of reference is hearing from artificial pancreas teams in Virginia and Boston, both of whom have said that the FDA has not been a hindrance to their efforts, and that they work with them closely. As always, thanks for your comments!


  • Photograbetic  On September 19, 2014 at 8:04 pm

    This is awesome and so inspiring! Thanks for being a voice for the DOC!!


  • Scott E  On September 19, 2014 at 9:30 pm

    When it comes to the FDA, I *do* believe they are a bottleneck (see as comparison: Europe), but I don’t believe it is maliciously so. I used to — but then I read somewhere that the problem is that the FDA is simply too small an organization to be able to review and respond to all of the applications they receive as quickly and as thoroughly as they like, and my resentment began to turn to sympathy.

    Then, several months ago, I read about a test strip that was submitted to the FDA, and while the FDA had no grounds to flat-out deny it, they conditionally approved it with a warning on the box that stated people should not dose insulin based on results of these strips.

    I then read a reply from a spokesperson of that company, which essentially said “we don’t have any plans to market this product because it’s not fully developed, but by getting it in the system now, we can avoid the lengthy process later when we ARE ready”. That’s cheating the system and it wastes the FDA’s precious time — and it made my sympathy turn to anger. It’s almost like they are the ones who get on line early at the grocery store while their partner runs through the aisles collecting items and delivering them to the cart. Unfortunately, I’d bet this type of behavior is the norm rather than the exception, and it’s probably a good part of the reason the FDA is so backlogged.

    I don’t doubt the FDA’s good intentions, but when they are understaffed and underfunded, while manufacturers continue to waste their valuable time with incomplete products like these, it’s no wonder they get a bad rap.


  • Mike Hoskins (@MHoskins2179)  On September 22, 2014 at 3:11 am

    Thanks for this great post, and simply for writing the comment to the FDA and having the follow-up conversation with them. It’s so important, and this is huge. Agreed, that it reiterates how interested and willing the regulatory agency is in having these conversations and establishing relationships with us. Yes, I pretty much agree with Scott above — that examples like the one he mentioned do nothing but cheat the system. The FDA is bound by laws, and we all know how ineffective and loop-crazy Congress is when writing any legislation. I’m very pleased to see all the progress that’s happened within the FDA in the past couple years, in making things move more quickly and efficiently where appropriate. But I also think that we, as patients, must be accurate and fair in talking about the FDA — it’s often not their fault, but what the companies do or don’t do during the regulatory process that causes the delay. We need to keep that in mind, and make sure we understand who’s at fault (if that’s even possible) before just blanketly blaming the FDA for delays — the Animas Vibe and Medtronic 530G are two specific examples of this, where it WAS NOT the regulators’ fault but moreso the companies. Anyhow, these conversations can help get word out that the FDA cares about us, and we can help keep everyone accountable.


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