FDA denies citizen petition calling for electroconvulsive therapy ban
FDA has dismissed a citizen petition calling for electroconvulsive therapy (ECT) devices to be banned or only sold as Class III products.
The petitioners argued ECT presents an unreasonable risk of injury but failed to persuade FDA that the scientific literature supports that position.
FDA responded to the petition after working on a final order that will reclassify ECT devices as lower-risk Class II products in certain instances.
FDA has spent close to a decade assessing the safety and efficacy of ECT devices as part of its efforts to determine whether it was right to put the products in Class III in the 1970s. Part way through that assessment process, an attorney filed a citizen petition on behalf of five people who had undergone ECT.
The petition described how the five people suffered from memory loss and other side effects after receiving ECT. In light of these cases, the petitioner argued that FDA should ban ECT devices, or at least keep their high-risk Class III status, as they pose an unreasonable risk of injury.
FDA took a different view. In its response to the petition, FDA stated that it disagrees with the view that ECT poses an unreasonable risk of injury, pointing to the body of evidence on more than 1,000 patients that it reviewed when assessing whether to reclassify the devices. FDA thinks the literature shows ECT is associated with "minimal and reversible adverse events," at worst.
"In some cases, patient memory and mood improved while treating catatonia or a severe [major depressive episode] associated with [major depressive disorder] or [bipolar disorder]. Positive results included outcomes in both adults and adolescent subpopulations," FDA wrote in its response.
The singling out of data suggesting ECT can have positive effects on the memory of people suffering from catatonia or a severe major depressive episode supports FDA's final order. While FDA is keeping most uses of ECT devices in Class III, it thinks the risk-benefit profile in catatonia and severe major depressive episodes supports their reclassification into the lower-risk Class II.
- Regulations.gov Letter from FDA CDRH to Emord and Associates, P.C.
- Emord & Associates Citizen Petition
- MedTech Dive FDA reclassifies some electroconvulsive devices in final order