The Juvenile Diabetes Research Foundation unveiled a petition today, signed by more than 100,000 senators, doctors and patients, urging the FDA to issue swift and clear guidance for the development of an artificial pancreas for diabetics.
The petition, which was posted on the JDRF’s website Oct. 3, calls for the federal watchdog agency to issue a guidance that speeds up its recommended device development restrictions, allowing short-term, in-hospital evaluations of artificial pancreas systems and followed by outpatient trials of no more than three months long.
The JDRF expects the federal watchdog agency to issue the guidance by Dec. 1.
"The FDA has a real opportunity not only to foster innovation but also to help diabetes patients in the United States by issuing the draft guidance on time and by taking into serious account the scientific consensus on the safest and most rapid way forward," said Senator Susan Collins (R-Maine) in a press release.
Clinical experts herald an artificial pancreas as the biggest step in diabetes care since the discovery of insulin, according to the JDRF.
"Just last week in Italy and France, results from an outpatient trial for the artificial pancreas were announced. We need this innovation here in America," added Collins.
The FDA granted Medtronic an investigational device exemption for the second phase of the Automation to Simulate Pancreatic Insulin Response trial, which will involve in-home study of its subjects (the trial’s first leg involved in-patient treatment).
It’s designed to test the low glucose suspend feature in Medtronic’s MiniMed Paradigm insulin pump and its Enlite continuous glucose sensor.
The federal watchdog agency’s medical device review and approval process has been getting some flak from lawmakers recently. House Republicans introduced 10 bills aimed at the FDA’s medical device review and approval process.