6:04 PM EST, December 1, 2011
CHICAGO (Reuters) - The U.S. Food and Drug Administration issued new guidelines to medical device makers developing a potentially revolutionary device for type 1 diabetes, saying they should speed its delivery to patients.
The guidelines reflect months of behind-the-scenes negotiations with patient advocates, medical device makers and researchers working to develop an artificial pancreas -- a complex system of pumps and sensors aimed at automating the care and treatment of type 1 diabetes.
Diabetes advocates had feared the FDA would set the bar too high, making regulations so cumbersome that it would delay access to diabetics in the United States.
"This guidance was developed in a way to account for innovation," Charles "Chip" Zimliki, who heads an FDA initiative to speed up availability of an artificial pancreas, told Reuters in a telephone interview.
He said the new draft guidance gives researchers and medical device makers a clear set of requirements for approving clinical trials that can show the technology is safe in real-world settings.
"We're showing them a path that I think can get them to a safe and effective product in the U.S.," he said.
The devices are meant to help the 3 million Americans with type 1 diabetes, a disease in which the immune system destroys cells in the pancreas that make insulin.
Patients must monitor their blood sugar and inject themselves with insulin throughout the day to prevent diabetic complications such as blindness, and heart and kidney disease.
An artificial pancreas would continuously monitor blood glucose levels and automatically deliver the right amount of insulin to the body when it was needed. But the potential for malfunction of these complex devices to cause serious harm raises the stakes for proving their safety.
"We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
Patient advocates feared the FDA would take an excessively cautious stance, pointing to requirements issued in June for a very early version of an artificial pancreas device that is already sold in 50 countries but not the United States.
"It was a guidance for a product that had already been approved around the world, had been used by thousands of people with significant positive impact, and the U.S. was significantly behind on that front," Aaron Kowalski, lead researcher at the Juvenile Diabetes Research Foundation, told a media briefing.
The influential group ran an aggressive lobbying effort to urge a different approach for the much more complex artificial pancreas systems now in development.
JDRF Chief Executive Jeffrey Brewer said the group was "guardedly optimistic" about the FDA's draft guidelines and that they showed the agency had listened to researcher concerns. The group will review them in greater detail in the coming weeks.
The artificial pancreas systems are worn outside of the body. They combine the continuous glucose monitor that takes blood sugar readings through a tiny sensor placed just under the skin with an insulin pump, all driven by a computer "brain" or algorithm that calculates the right insulin dose.
"There are no systems on the market now that dose insulin automatically. This is an opportunity to get the U.S. back in line with the rest of the world and really pave the road to improve patient outcomes," Kowalski said.
The FDA guidelines recommend a three-phase clinical trial series that would begin by monitoring patients carefully in a hospital and then lead to testing in the real world.
They suggest ways researchers can use existing safety and effectiveness data for the system's different components, including clinical studies conducted abroad.
The final version will help manufacturers and researchers seek approval for conducting clinical trials and for their finished products. FDA did not provide a timetable.
"I think they did really well," said Dr. David Nathan, a diabetes expert at Massachusetts General Hospital and a professor of medicine at Harvard.
Nathan served on a committee put together by the JDRF to advise the FDA on the guidelines and is leading one research team out of about a half dozen globally that are developing an artificial pancreas.
(Editing by Michele Gershberg and Cynthia Osterman)
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