APP Regulatory Happenings

If you have been following the coverage of the recent Children’s Congress, you know that there has been important APP news related to FDA.  Many of you have been working hard since Government Day in March to educate your legislators about the artificial pancreas and as a result of your efforts, a bipartisan majority in the House and Senate sent letters to the Commissioner of FDA to urge them to continue to make the artificial pancreas a priority and issue guidance as soon as possible.  In addition to this letter, leading clinicians from around the country and organizations including American Association of Clinical Endocrinologists, The Endocrine Society, and American Association of Diabetes Educators also sent letters to Commissioner Hamburg supporting the recommendations included in the guidance JDRF proposed to FDA. 

These issues were the focus of the recent JDRF’s Children’s Congress Senate hearing, which featured testimony from the actor Kevin Kline, officials from the National Institutes of Health and FDA, and four child delegates.  At that hearing, the FDA representative, Dr. Zimliki, committed that FDA will release draft guidance for artificial pancreas technologies in December of this year.  Although we will continue to urge the agency to move more quickly, we are pleased that FDA has committed to a timeline and will be working to ensure they meet it.  Without the work of all of you and the support you garnered, this commitment would not likely have happened.  Thank you!

Another bit of APP news last week is that the FDA released a draft guidance on low glucose suspend systems, which turns insulin off when a CGM shows a person’s blood glucose reaches a low threshold or is predicted to get to that point.  This guidance from the FDA is long overdue – this product is already in use around the world, a source of great frustration to many of us.  While it is helpful that the FDA has released this guidance, what we really need them to do is produce guidance for artificial pancreas systems that both turn insulin on as well as off, to prevent delays in the development of these systems.  As Kevin Kline said in his Senate testimony,

“In other countries, there are devices available that take the first step, by automatically shutting off the insulin pump when someone is low.  This is an important first step we need in the United States now. 

But we can do more than that.  JDRF and federally funded research have, in hospital settings, tested artificial pancreas technologies that automatically turn insulin both on and off – and the results have been amazing.  The next step is testing these artificial pancreas devices in real-world settings.  To do this without delay, however, the FDA needs to provide clear and reasonable guidance. Many of the world’s best diabetes researchers and leading clinician organizations have joined together with JDRF to propose artificial pancreas guidance to the FDA.  And the majority of the Senate and the House have urged the FDA to give this proposal immediate consideration. Now we need the FDA to act. 

Parents who are up every night and worrying every day about their children simply cannot afford to wait any longer.”

Kerry Morgan, a 17-year old Children’s Congress delegate, testified about her experience in a JDRF funded clinical trial, saying,

“After participating in clinical research since I was three years old, I can honestly say the closed loop artificial pancreas trial was the most amazing experience of my entire life and holds so much promise for people living with this disease. 

For two days, I had perfect control of my blood sugar levels.  Two days of living with this technology provided me with a vision of what life could be like: Life with FAR LESS fear of complications both short and long term.  Creation of an artificial pancreas is within reach, I know it, I’ve been a part of it, and I will do all I can to get it into the hands of people living with diabetes, and I hope you will too.

So, on the day the artificial pancreas is finally approved and released, people with this disease can say, “Diabetes: There’s an APP for that.”

And, as International Chairman Mary Tyler Moore said in her testimony, “I know that if I had had an artificial pancreas 40 years ago, I would likely not be facing such a heavy burden of complications as I do today. Please, take action now so the children here today will have the opportunity that I did not, an opportunity for a life free from the many daily burdens of diabetes.”

For more, see the Senate hearing press release, written testimonies, and video of the entire hearing as well as of Kevin Kline and Aaron Kowalski on CNN’s American Morning. 

As I write this on June 24th, this is my last day in the office before maternity leave, so it will be a little while until you hear from me again.  But the JDRF team will keep up the fight, and look for future blog posts from Cynthia Rice on APP regulatory developments.