The FDA Discusses the Future of Electroshock Treatment

Next week the United States Food and Drug Administration (FDA) will meet to discuss the future of electroshock devices, whether to downgrade the restrictions on its use or make the treatment more available. Each year an estimated 100,000 Americans undergo the treatment for major depression and other conditions. Two-thirds of these patients are women.

Electroshock therapy is a historically controversial, psychiatric treatment in which seizures are electrically induced in anesthetized patients for therapeutic effect.  The American Psychiatric Association and other leading experts are recommending that the FDA downgrade the devices, making the now “high-risk” treatment “medium-risk.”  If this occurs, equipment for such treatment would be regulated like syringes and surgical drills.

According to Dr. Matthew V. Rudorfer, a psychiatrist and top specialist at the National Institute of Mental Health: “These tend to be mom-and-pop operations. So I think the dilemma might be that undergoing new expensive clinical trials might be too expensive.” According to Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York: “It’s all trial and error — it’s all experimental. All the years it’s been controversial and there have not been clinical trials. Why not?”

The FDA review was recommended by the U.S. Government Accountability Office in 2009 as part of an examination of the treatment’s regulatory status, as well as other less controversial medical devices (such as pacemaker electrodes and implanted blood access devices).

More information about the FDA’s review can be found at