A Food & Drug Administration advisory committee is considering whether to ease regulations on electro-shock therapy devices for treatment of illnesses such as depression.
The FDA’s Neurological Devices Panel is meeting today and tomorrow to hear testimony and discuss whether the agency should lower the device’s risk classification from Class III to Class II.
The reclassification would mean electro-convulsive therapy devices would no longer be subject to the FDA’s more-stringent pre-market approval pathway. A Class II designation would allow ECT systems to pass through the agency’s 510(k) clearance protocol, which most medical devices go through before reaching the marketplace. It would be a boon for makers of ECT equipment because the 510(k) program requires less testing and less rigorous manufacturing standards — and therefore costs less. There are only two U.S.-based manufacturers of ECT devices: Lake Bluff, Ill.-based Somatics LLC and Lake Oswego, Ore.-based Mecta Corp.
ECT has been prescribed since 1938, but after its use waned in the 1950s and ’60s with the development of modern pharmacotherapy, which was comparatively safer than early ECT treatment. But ECT’s popularity has risen more recently as a treatment for psychiatric disorders such as major depression, schizophrenia and bipolar states, according to the FDA advisory committee’s executive summary (PDF). ECT is usually considered after one or more antidepressant medications fail to treat a patients, or "when there is need for a rapid and definitive response," according to the summary. The committee cited estimates that put the number of patients receiving ECT in the U.S. at 100,000 per year.
The FDA wants the committee to make recommendations (PDF) relative to the risks of ECT, including memory loss, cardiovascular complications and headaches; indications for the device’s use; and potential regulations for the devices, such as mandatory doctor training, labeling, and additional pre-market studies.
The most common side effects from ECT are headache, upset stomach and muscle aches. Some patients experience memory problems, especially of memories surrounding the time of the treatment, according to the National Institute of Mental Health.
Somatics founder and electroshock textbook author Dr. Richard Abrams wrote to the FDA ahead of the meeting and claimed that none of his patients in more than 10,000 sessions "suffered persistent, permanent, or prolonged memory loss." In his testimony, Abrams urged the FDA to “reclassify the ECT device to Class II without further delay.”