Template letter on ECT
Stephen Ostroff, M.D.
Acting Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: [FDA: 2015-32592] Neurological Devices; Reclassification of
Electroconvulsive Therapy Devices Intended for Use in Treating Severe
Major Depressive Episode in Patients 18 Years of Age and Older Who Are
Treatment Resistant or Require a Rapid Response;
Dear Acting Commissioner Ostroff,
Electroconvulsive therapy, more commonly known as “ECT,” is an important
treatment option for some people with severe mental health conditions. As a
psychiatrist who regularly treats patients who may benefit from ECT, I fully
support the Food and Drug Administration’s proposal to reclassify ECT as a Class II
medical device. Your proposed reclassification will greatly improve access to safe,
effective treatment for individuals with serious and persistent psychiatric
disorders.
INSERT PERSONAL EXPERIENCE HERE, SUCH AS I have treated many patients with
major depressive disorder and bipolar disorder, two conditions for which ECT is
an effective treatment. Depression is one of the most common mental disorders,
affecting an estimated one in 15 adults in any given year. Depression is a leading
cause of suicide, and contributes to morbidity, mortality and economic burden
worldwide. While most people with severe depression respond to medications or
other modalities, a number of patients with severe illness find that these
treatments are ineffective or contraindicated. For these patients, ECT can be a
highly effective and rapidly acting treatment, restoring them to a high function.
CAN ADD PERSONAL ANECDOTE HERE.
The American Psychiatric Association (APA) considers ECT a safe and effective
evidence-based medical treatment, and endorses its use when administered by
properly qualified psychiatrists for appropriately selected patients. In addition to
the APA, the American Medical Association, National Institute of Mental Health,
U.S. Surgeon General’s office and similar organizations in Canada, Great Britain
and many other countries recognize ECT as an appropriate treatment for mental
illnesses.
As an expert in mental health, I concur. ECT is safe and effective, and should be
available to patients experiencing a major depressive episode. I urge FDA to move
forward with the proposed plans to reclassify ECT as a Class II medical device for
those patients.