Tag Archives: Katherine Serrano

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Last year, Strip Safely helped lead a campaign to get more people to comment on FDA draft guidance for glucose meters.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 That’s about six or seven times the number of comments they generally receive on draft guidance.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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