Can the Diabetes Community respond to FDA’s Challenge?
FDA is holding a hearing on July 21 to consider a labeling change application by Dexcom for the Dexcom G5®. This panel will not wait for patient voices; they will vote on the 21st with or without our input.
The hearing will consider labeling for the G5 to be a “replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.” This would mean less fingersticks beyond calibration. Many individuals are already making treatment decisions off CGM readings, but currently, this is considered “off-label.”
FDA flat out Challenged the DOC – Are We 5,000 Strong?
During FDA’s Artificial Pancreas Webinar with DPAC on June 2, Dr. Lias spoke specifically about the July 21 hearing. From my perspective, and I was there, FDA flat out challenged our community, “If people want to organize together and submit… a single comment with a lot of signatures that’s one thing… ‘this comment represents 5,000 of us.’”
Why Your Signature Matters
Coverage is based on labels. The change FDA is considering will help people with diabetes get and keep CGM access. CGM coverage hinges on providers seeing it as a primary, necessary tool in diabetes care, rather than just secondary to fingerstick blood glucose monitoring. Medicare currently does not cover and continuous glucose monitoring because, they say, CGM is not a primary tool. Some private payers are following Medicare’s lead and putting up access barriers to CGM. This replacement labeling is critical to covered access to CGM.
DPAC Makes It Easy To Matter
Here’s an excerpt:
We enthusiastically support the application to advance the label for accurate continuous glucose monitoring systems.
As people living with diabetes, we have a unique perspective of risk. Insulin is a very dangerous drug; too much or too little have both immediate and long-term complications. Those who use insulin daily manage dosages to mitigate these risks. We rely on a complex combination of treatment protocols created in collaboration with our healthcare professionals to make rapid self-management steps throughout the day.
We intimately understand there is no perfect diabetes path.
The American Diabetes Association Standards of Care recognize that “one size does not fit all.” They go on to emphasize that “for optimal outcomes, diabetes care must be individualized for each patient. A critical part of optimization is putting the appropriate tools, with the right labels, in the hands of the patient.
All devices, medications and management plans have risks. We accept these tradeoffs as part of the balance of daily life. We seek out high-quality tools to help successfully take careful steps that strike a balance between the possibility of an immediate health emergency from too much insulin and the likelihood of long-term health complications from not enough.
Signing takes a few clicks and adds your support to the 5,000 signatures needed. Click, fill in your name, and submit.
They are not waiting.