December 20, 2009
To: Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket # FDA 2009-N-0392
From: The Depression and Bipolar Support Alliance (DBSA)
730 N. Franklin Street, Suite 501, Chicago, IL 60654
As the nation’s largest peer-directed mental health advocacy organization, the Depression and Bipolar Support Alliance has a vested interest in the development of technologies that aid in the recovery of the millions of Americans living with a mental illness — specifically the more than 15 million Americans living with depression.
Depression is the leading cause of disability in the United States and according to the World Health Organization (WHO) by the year 2020, depression will be the leading cause of disability worldwide.
We are now in a time of reform and transformation of our healthcare system, and to that end, DBSA is actively engaged in advocating for greater access to new treatments and the same quality of care afforded to other physical illnesses.
We are pleased to hear that the FDA will now require electroconvulsive therapy (ECT) to undergo the same scrutiny as all other medical devices.
However, we ask you to give very careful consideration before reclassifying the device to a Class ll.
As part of its Class Ill designation, the device would have to undergo PreMarket Approval (PMA) to establish the safety and efficacy of the device through a process that includes clinical trials.
If the device is reclassified as a Class Il, the rigorous scientific safety investigation of these devices may never take place — preventing patients from making informed choices about their treatment. DBSA also strongly endorses the continuous review of the quality of treatment, the equipment and training of providers and outcomes.
A Lack of Real Progress
Despite an increased interest and advocacy for the illness in recent years, there has not been much progress.
Changes in care such as prevention, recovery methods and improving the lives of those living with depression are just not happening fast enough — and are not having a large enough impact on the lives of these individuals.
Stigma and misunderstanding of the illness by the public and an extremely complex system of care have all combined to create significant challenges for even accessing adequate treatments.
Because depression is a serious and life threatening medical condition, new and improved treatments and the development of new technologies to aid in the recovery of the millions of Americans are crucial because more than 80 percent of those living with depression do improve with the right treatment.
In short, depression is a devastating illness, but one that can be successfully treated.
Access to safe and efficacious treatments is fundamental to the health of all Americans.
DBSA asks that the ECT technology be proven to be as safe and effective as other treatments. Thank you for you consideration.