The Juvenile Diabetes Research Foundation (JDRF) has recently encouraged FDA to speed development of new treatment options for diabetes. In researching this issue, MD+DI contacted Cynthia Rice, who is the vice president, government relations for JDRF. The questions we posed are in bold while her answers immediately follow:
What is holding FDA back from approving the use of low-glucose suspend systems in the short term?
For many years, FDA was not clear about what studies manufacturers would need to conduct in order to receive approval for low glucose suspend systems in the United States. As recently as November 2010, when FDA hosted a public workshop on artificial pancreas systems, the FDA requirements were not yet clear. Thus, devices which were approved in Europe in 2008 are still not approved in the United States. The FDA recently took an overdue step to clarify the requirements for low glucose suspend systems when it released a draft guidance on the topic on June 20th.
What concrete steps should FDA take in the short term to address the diabetes epidemic?
The FDA should expeditiously issue guidance on more advanced artificial pancreas systems by this fall so that these systems are not delayed in the U.S. We need immediate action by the FDA to ensure that artificial pancreas systems – which would turn insulin both on and off as needed — can move to the next stage of testing. If not, this promising technology could be delayed and available overseas long before it is available in the U.S., as low-glucose suspend systems have been.