December 11, 2009
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket #FDA 2009-N-0392
To Whom It May Concern:
Maryland Disability Law Center (MDLC) is Maryland’s Protection & Advocacy agency, mandated to advance and defend the rights of people with disabilities.
We write to express our views on a matter of great concern, the safety of devices used to administer electroconvulsive therapy (ECT), a treatment method fraught with controversy.
The Food & Drug Administration (FDA) originally classified ECT devices as Class III, ruling that memory loss and brain damage were among the associated risks.
Without producing the requisite evidence refuting the presence of these significant risks, and under pressure from certain stakeholder groups, the FDA has announced its intent to reclassify ECT devises as Class II.
MDLC strongly opposes such reclassification.
The proposed action would mean that ECT devices would never have to undergo the safety investigation (Premarket Approval Application, or PMA) that is required by law for Class III devices predating the Medical Devices Amendments.
It would effectively stamp ECT as a safe treatment (as safe as X-rays) that doesn’t need an investigation.
ECT devices have now been used on another generation of patients without being proven safe, and without warning patients that there is no evidence of their safety.
Finally this year, FDA has been forced to decide whether to keep the devices in Class III and require PMAs, or to reclassify.
As an initial step, it has called on the manufacturers to provide evidence of their devices’ safety, but the manufacturers have not done so.
They are refusing to conduct clinical trials, alleging that they cannot afford them.
Consumer protection is paramount and the financial interests of manufacturers must not be basis for the nation’s highest authority on medical matters to reclassify ECT as a low risk treatment.
There is no scientific basis for reclassification, and it is doubtful that such basis in fact exists.
FDA must not exempt ECT from the scientific scrutiny required of all other psychiatric and medical treatments.
For the protection of vulnerable patients, keep the device in Class III and require PMAs.
Only if clinical trials are completed could FDA take responsible action on ECT devices.
Thank you for considering this pertinent information.