After a US Food and Drug Administration (FDA) panel’s recommendation that electroconvulsive therapy (ECT) devices retain their high-risk class III classification, the American Psychiatric Association (APA) fears that the future of ECT for the treatment of severe, drug-resistant depression and other serious mental disorders is now in jeopardy.
If the FDA decides to follow the advice of its Neurological Devices Committee, it means that the 2 companies that currently manufacture ECT machines would have 30 months to submit a premarket approval to show that the devices are safe and effective.
ECT has been in use since before the FDA enacted new, more stringent laws for device approval, and psychiatrists fear that the logistics of conducting new trials will pose insurmountable problems for the manufacturers.
They also doubt whether data from any new trial would be sufficient to convince a subsequent advisory panel of the efficacy and safety of the devices, long considered by the APA to be life-saving.
“It hasn’t been yanked from the market right now,” said Sarah H. Lisanby, MD, head of psychiatry, Duke University, Durham, North Carolina, and chair of the APA Task Force to Revise the Practice of Electroconvulsive Therapy.
“But the continued availability of this life-saving treatment in the long term lies in the hands of the FDA right now. We’re pleased it wasn’t taken off the market instantly, but if new trials are going to be required, it’s not clear who will fund them and whether they will in fact even be done. This is the concern,” she told Medscape Medical News……
Medscape Medical News