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The maddeningly slow FDA approval process and why things are probably getting better

Published: 9/30/11
10 readers recommend
By Kelly Close

Greetings from San Francisco,

Americans think fondly of Europe for many reasons – its rich history, its magnificent cities, its direct ties to so many in this country. We love all those reasons, but we think fondly of Europe for another reason as well – its regulatory environment for diabetes products.

This came to mind when we recently attended the annual meeting for the European Association for the Study of Diabetes, in Lisbon, Portugal. This is the major meeting for diabetes in Europe for the year, and what struck us was the exhibit floor, where companies were displaying their products.

By September, we’ve already seen a lot of exhibit floors, most notably those for ADA and AADE, America’s main doctor and diabetes educator meetings, respectively. Often these floors blend into each other (in a nice way).

But not this year, not in Portugal, where we saw so many products that EU regulatory authorities have approved that remain unavailable in the US. It was like Christmas in Lisbon! And Diwali and Chanukah as well. We saw Bydureon. Check. We saw the Animas Vibe integrated pump/CGM. Check. We saw Cellnovo, the new pump that got EU approval during the meeting. Check. We saw the smaller, thinner next-gen insulin pods for OmniPod. Check. We saw the next-gen Medtronic sensors and the Veo, again. Check. (That wasn’t new – the Veo has been approved in the EU since 2008 and available since 2009!) We saw Sanofi/AgaMatrix’s iBGStar, the blood glucose meter that plugs into an iPhone. Check.

This is maddening. Whether you have diabetes in Norway or Nebraska, your needs are the same. Why shouldn’t you have access to the same products? DLife asked me recently to reflect on the regulatory environment and where the FDA stands – here is the link to the show http://www.dlife.com/dlifetv/video/fda, which just aired in mid-September. I spoke alongside former FDA official Dr. Zan Fleming, which was a big honor.

In recent years, the FDA has been far more cautious in approving new diabetes products, in large part because of criticism that it had been too lax in approving drugs or devices whose safety was later questioned. Whether that criticism is fair is open to debate, but the impact for both drugs and devices has been stricter trial requirements, product delays, and in some cases, less investment in new and safer diabetes therapies. Additionally, the FDA is dramatically under-resourced, which only further delays the approval process. This impacts not only review timing (it's slower) but also employee retention - the best people should want to stay at the FDA once they develop expertise but are instead frequently overworked. Thus, as patients we are lucky so many incredibly committed people work at the FDA but there is the constant, ongoing risk they will leave because they cannot afford to stay.

Not all the news from the FDA is discouraging. The agency is showing a bit more movement on two obesity drugs, which we hope is a sign that it recognizes the urgent need for safe, effective treatments in this area. See inside for our coverage.

Do you want a breakdown of CGMs – and which one would fit your needs, and your personality, the best? See Gary Scheiner’s column inside for his straightforward assessment.

Many of you give us your opinions about diabetes products each quarter for dQ&A - these comments help companies develop new and improved products for people with diabetes. If you are interested in sharing your own opinions and aren’t yet, write [email protected] for details. Tune in next month for our download of what you have said to dQ&A that has made a difference. Have an excellent October!

Very best,

Kelly L. Close

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