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The artificial pancreas takes center stage at ADA, but can the FDA keep up without more resources?

Updated: 8/14/21 9:00 amPublished: 7/22/13

Last month, the American Diabetes Association hosted its 73rd Scientific Sessions for five days in Chicago. This event is always the highlight of our year at diaTribe, and for me, for reasons both obvious and subtle. Of course, it’s always great to be present for the launches of promising new products, such as Johnson & Johnson’s SGLT-2 inhibitor Invokana (canagliflozin), Insulet’s second-generation smaller OmniPod, and new weight loss medications from Vivus (Qsymia) and Eisai/Arena (Belviq). The ADA meeting also provides an invaluable opportunity to hear firsthand all the latest data and opinions from the field’s leading experts – something we discuss in detail in our extensive ADA conference pearls. But nothing at ADA attracted more excitement, or represented a clearer shift in experts’ thinking, than the artificial pancreas.

At last year’s ADA, the artificial pancreas was viewed as an intriguing possibility, a research path and academic area that clearly deserved careful attention but was still not being tested in a real-world setting. But now? In just 12 short months, we appear to have reached critical mass, and the artificial pancreas is seen now as a matter of “when,” not “if.” And I don’t simply mean that those working on artificial pancreas projects are confident that they are on the right track; this is now a belief held by experts from all over the field – as well as the vast majority of patients that have now taken part in these exciting outpatient trials.

At a press conference on the results of the ASPIRE in-home trial of the Medtronic MiniMed 530G (the US version of the Paradigm Veo, which suspends insulin delivery if the user does not respond to low CGM alarms), Dr. Richard Bergenstal captured the mood of the conference: “I can tell you, for the first time in my 30 years, I’m really feeling that this artificial pancreas is feasible. Before we said it’s a dream. Now I think that we have the first part of it, I think we will see this develop.” A lot of things still have to go right for the artificial pancreas to become a reality, but we now know what all those individual steps are.

For example, challenges remain as companies seek to bring the actual product to market. Every year at ADA, the JDRF holds a special meeting on the artificial pancreas, with scientists and industry representatives from all over the field to discuss the latest updates. It was great to see FDA representatives at the meeting, which we interpreted as a sign of engagement. But those representatives almost weren’t there, as their travel for ADA – the single most important conference for one of our country’s greatest public health problems! – wasn’t approved until the last minute. The reason? “Budgetary constraints.”

The problem is that the FDA is vastly underfunded – and it has to make extremely hard choices on how to spend its funds. It must regulate $1 trillion of products with a budget of just $4 billion. The result is that even something as fundamentally important as FDA attendance at ADA is carefully scrutinized. We continue to be disappointed by this state of affairs, because we know how many great people work there and how committed they are to improving the lives of those with diabetes.

Many believe that the FDA can get by just fine with the minimal funding necessary to complete essential operations. But without the extra resources necessary to define approval pathways for innovative treatments, to speed up the review and approval process, and to hire additional high-caliber staff, the FDA can only do so much to improve people’s health – and, by extension, cut down on preventable medical costs – in the long run. Some may think the FDA’s job is not to improve people’s health – as a reminder, the FDA’s very mission says it is to protect and advance the public health. More funding in the short-term could mean significant, tangible savings in the long-term, not to mention countless lives improved and saved. That’s a message I hope will resonate with taxpayers, and one I hope the FDA will begin to put forward. This is especially important now because the FDA is making a real effort to become more patient-centric. For instance, the agency now has a patient-oriented website (click here), a diabetes-specific section of its website (click here), and a Diabetes Monitor newsletter (click here – and subscribe!).

I recently spoke with FDA Commissioner Margaret Hamburg, who said that there could soon be an FDA-sponsored patient meeting all about diabetes. Such a meeting would identify what barriers still exist that prevent the most effective treatments and what the FDA can do to solve these problems. What sorts of ideas, concerns, or questions would you want to raise with Commissioner Hamburg and the FDA? You can send them to us by clicking here, and we’ll do everything we can to make sure these collective ideas get to the right people. Let’s lead the charge toward more active public engagement with the FDA. It’s the best way to ensure the organization keeps working in our best interests.

Very best,

Kelly L. Close

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