Jeffrey Brewer, 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 its review of the artificial pancreas. It is a portable device used to help people with type 1 diabetes control their blood sugar levels by using an insulin pump, continuous glucose monitor and software.
Son of beer has type 1 diabetes, ie, their body does not produce insulin. Type 1 diabetics either have to self-administer insulin pumps or use insulin release throughout the day.
"Diabetics have self-prescribed insulin throughout the day, and can occasionally make mistakes and be killed" he said. "My son almost died because he took too much insulin. The insulin pump does not have the right features to cut the supply of insulin."
According to the JDRF, as many as three million Americans may have type 1 diabetes, and Brewer said the artificial pancreas can potentially save the lives of people.
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However, the FDA said, has been slow in moving along the approval process. In an effort to accelerate what product to market, JDRF, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), health professionals, and people with type 1 diabetes met in Washington, DC, on Wednesday to urge the FDA to take faster action.
FDA approval policies delay devices, group claims
Brewer said his goal is to encourage the FDA to implement changes in policies and guidelines that allow devices to market faster and also allow the investigation of new products to help control insulin. The FDA, in response to criticism, says he is anxious that the product is available, but be sure it is safe and effective for consumers.
"The policies of the FDA has delayed the introduction of products such as artificial pancreas to the U.S. for up to three years that are being used safely by people around the world with type 1 diabetes, and prevent us from doing basic research in the U.S., "said Brewer.
The FDA is preparing recommendations to make the artificial pancreas approved for use in the U.S., but Brewer said that the board of the agency - draft guidance called - Delay in the approval process and does not take the recommendations of the experts into account.
He cited the low glucose suspend the systems, devices that suspend the supply of insulin in response to low blood sugar, as an example of slow progress.
"He has just published a guide in June, but the product has been available in Europe for over three years," said Brewer. He and other advocates are urging the FDA to seriously consider the opinions of experts almost unaminous artificial pancreas can dramatically improve the lives of people with type 1 diabetes.
The Washington meeting is one of the JDRF's efforts to push forward the FDA. The group also took out full-page ads in newspapers and posted a petition on their website. That the petition, the JDRF, said, received more than 100,000 signatures in just three