Category:FDA Proposed Rule Change on Electroconvulsive Therapy (ECT)
|“||The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls) based on new information.||”|
Proposed Rule. Posted: 12/29/2015. Docket ID: FDA-2014-N-1210-0001. Public Comment Period closed on Mar 28, 2016 with 3,408 comments received. Docket Status: OPEN as of Aug 2016.
- CCHR lobbyist disclosed he was targeting this regulation change in Congress on behalf of his client during first two quarters of 2016.
- In response to the APA issuing a new alert calling for comments from psychiatrists in favor of ECT re-classification, an Action Alert Email from CCHR-Texas was sent out one week prior to the Public Comment Period closing, which encouraged scientologists to submit public comments referencing three press releases published on NaturalNews.com by J. D. Heyes.
- 25 comments referencing CCHR, the NaturalNews.com press releases or other known Scientology agents were formally submitted to the FDA for this regulation change as of Aug 2016, but only 13 were received and officially recorded to the docket prior to the Public Comment Period closing.
- CCHR President Jan Eastgate submitted 2 comments, but only one Comment from Jan Eastgate was received prior to the Public Comment Period closing.
- Dr. John Breeding, President of the CCHR TX front Coalition for the Abolition of Electroshock, submitted two comments and was referenced in three others according to the public record. However, only one Comment from John Breeding was received prior to the Public Comment Period closing.
- 1 comment was received from the predominate CCHR advocate Peter Breggin four days after the Public Comment Period closed. While his published works were referenced in 668 other comments.
- 3 comments referencing Scientology Attorney Ken Moxon were received, with one Comment from Law Offices of Kendrick L. Moxon, P.C.. However, none of these were submitted prior to the Public Comment Period closing.
- Another comment received prior to the Public Comment Period closing that looks significant was the Comment from Dr Bart Billings, 2014 recipient of CCHR's Human Rights award.
- Following a recent article in the Washington Post that preceded Moxon's comment by one day, Kelly Patricia O’Meara from CCHR Int published a press release on July 22, 2016 calling for Congress to investigate serious conflicts of interest driving the Food and Drug Administration’s (FDA’s) decision to allow the wider use electroshock treatment (ECT).
- Neurological Devices; Reclassification of Electroconvulsive Therapy (ECT) Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older, Regulations.gov
- APA: Time is Now to Support the ECT Reclassification Effort. Psychiatry.org
- FDA: Electroshock has risks but is useful to combat severe depression, Washingtonpost.com
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