January 4, 2009
Re: Docket #FDA 2009-N-0392
To Whom It May Concern:
Disability Rights New Jersey, (DRNJ) is the designated protection and advocacy system for individuals with mental illness in New Jersey pursuant to 42 U.S.C. §§15041 to I5045.
DRNJ is responding to docket number FDA 2009-N-0392 and opposes the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and requests that the FDA call for Pre-Market Approval Applications for the device.
DRNJ believes that appropriate government oversight, through clinical safety trials, is necessary to ensure that ECT is safe, and all persons being provided with the option of this treatment are fully informed as both to its beneficial and potentially harmful side effects.
ECT is highly controversial with the potential for significant Iifelong consequences.
On more than one occasion this office has been asked to confirm a state hospital patient’s consent to ECT only to determine that the patient did not understand the decision he or she was being asked to make or that other less intrusive treatments had not been tried. (We have also had staff who did, and would again, consent to ECT.)
Choice and informed consent require that patients have full and complete knowłedge about the efficacy and short and long term consequences of ECT.
In the absence of adequate scientific evidence, the FDA must place the safety of the patients first and call for PMAS from the manufacturers.
Jennifer M. Halper Senior Staff Attorney/Legislative Coordinator