The News:
The FDA released a Guidance Document yesterday, December 1, that promises to accelerate the testing and potential approval of the Artificial Pancreas.
What this means for the T1D Community:
I have had December first on my calendar for months now.
Two weeks ago at the Silicon Valley Summit, I gained an even better sense of the crucial nature of the FDA Guidance Document we were awaiting.
The fact is that the Medtronic VEO–a low glucose suspend insulin pump that can be thought of as a step toward a product like the Artificial Pancreas–is available in 40 countries across the globe but not the United States because the FDA has not approved the system.
The fact is that if the FDA doesn’t quickly approve life-changing products like the AP, then components of it–continuous glucose monitors and insulin pumps–will not be developed and improved in this country because no markets for them will exist.
If this becomes the case, important innovations in the United States will not proceed and people with T1D will never have access to them.
I googled “FDA Artificial Pancreas” at least a dozen times yesterday.
Late in the afternoon, an email from Hasan Shah of JDRF Advocacy landed in my inbox. I was extremely pleased to learn that the FDA has come through with this important guidance.
According to Jeffrey Brewer, JDRF President and CEO: “Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field. It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP’s safety and efficacy, and if that turns out to be the case it is good news.”
Good news indeed!
Before December first, the FDA felt like an adversary of researchers and JDRF and individuals with T1D. Through the tremendous effort of JDRF–whose 110,000+ advocates signed a persuasive petition and whose media campaign drew significant attention and whose dialogue with senators and congressmen have meant great governmental support–we made our concerns and priorities very clear and the FDA responded just as we hoped they would.
With the Guidance Document, we feel more aligned.
I, for one, am more convinced than ever that we are closer to bringing a product to market that is thought to be as revolutionary for T1D as the discovery of insulin.
John Lipp, Executive Director of JDRF Bay Area said that yesterday was “a very good day.” I couldn’t agree more.
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