Major Push for Quicker Approval of Artificial Pancreas

PHOTO: Sen. Susan Colllins, (R-ME), co-chair Senate Diabetes Caucus speaks at a press conference, Nov. 2, 2011, in Washington, D.C to urge the FDA to issue clear and reasonable guidance on the artificial pancreas.
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Jeffrey Brewer, the president and CEO of the Juvenile Diabetes Research Foundation (JDRF), has a very personal reason for wanting the U.S. Food and Drug Administration to expedite their review of the artificial pancreas. It's a portable device used to help people with type 1 diabetes control their blood sugar levels through the use of an insulin pump, a continuous glucose monitor and computer software.

Brewer's son has type 1 diabetes, meaning his body doesn't produce insulin. Type 1 diabetics either have to self-administer insulin or use pumps that release insulin throughout the day.

"Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves," he said. "My son almost died because he gave himself too much insulin. The insulin pump didn't have the right features to shut off insulin delivery."

According to JDRF, as many as three million Americans may have type 1 diabetes, and Brewer said the artificial pancreas can potentially save those people's lives.

But the FDA, he said, has been slow in moving along the approval process. In an effort to expedite bringing the product to market, JDRF, Sens. Susan Collins (R-ME) and Jeanne Shaheen (D-NH), health professionals, and individuals with type 1 diabetes gathered in Washington, D.C., on Wednesday to urge the FDA to take quicker action.

FDA Policies Delay Device Approval, Group Alleges

Brewer said their goal is to encourage the FDA to implement policy changes and guidance that will allow devices to get to market faster and also allow for research into new products to help with insulin control. The FDA, in response to the criticism, says it is eager for the product to be available, but it needs to be sure it is safe and effective for consumers.

"FDA policies have delayed introductions of products such as the artificial pancreas to Americans by up to three years that are being safely used by people around the world with type 1 diabetes, and they prevent us from doing vital research in the U.S.," said Brewer.

The FDA is currently preparing recommendations for getting the artificial pancreas approved for use in the U.S., but Brewer said the agency's advice -- called draft guidance -- delays the approval process and doesn't take the recommendations of experts into account.

He cited low glucose suspend systems, devices that suspend insulin delivery in response to low blood sugar levels, as an example of the slow progress.

"They just issued that guidance in June, but that product has been available in Europe for over three years," Brewer said. He and the other advocates are urging the FDA to seriously consider the near-unaminous opinions of experts that the artificial pancreas can dramatically improve the lives of people with type 1 diabetes.

The meeting in Washington is another of JDRF's efforts to push the FDA forward. The group also took out full-page newspaper ads and posted a petition on its web site. That petition, JDRF said, recieved more than 100,000 signatures in only three weeks.

Study: Artificial Pancreas a Promising Option

Research published in April found that using the artificial pancreas was better at controlling blood sugar than an insulin pump. Low blood sugar during the night is often a problem for type 1 diabetics.

"[The system] has the potential to improve safety and efficacy of insulin delivery and may in future allow more flexible lifestyles in conjunction with improved glycemic control for people with type 1 diabetes," the authors, led by Roman Hovorka of the University of Cambridge.

The FDA, in response to the JDRF's criticism, says it's making proress with the artificial pancreas. The agency expects to deliver its draft guidance on the artificial pancreas by Dec. 1 and says it's currently on target to meet that goal.

One of the sticking points that could potentially delay approval is the fact that continuous glucose monitors are not approved to provide insulin dosages, only to alert a person that blood sugar is high or low.

"Today's insulin systems are basing all dosing decisions on that monitor, so we need to make sure we test them appropriately," said Charles Zimliki of the FDA's Office of Device Evaluation and chair of the agency's Artificial Pancreas Critical Path Initiative.

Zimliki also said the agency has never approved an artificial pancreas for use outside medical settings, but is making good progress on this one. The recommendations for the low glucose suspend system only took four months to complete; he said was a major achievement.

The FDA will release its draft guidance by Dec. 1. The public then has 90 days to offer feedback on it, and after that, the final recommendations are expected in 2012.

Zimliki, a type 1 diabetic himself, said he wants the device to be approved as quickly as possibly.

But Brewer said it still takes too long to get this life-saving equipment into the hands of the people who need it.

"We don't need guidance. We need to have the products," he said.

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