Official Complaint Filed with FDA Ombudsman Office 4 Days to Respond #FDAStopTheShockDevice
Mar 24, 2016 — Thank you to 1,329+ Supporters! Help us go viral!
On March 22, 2016, people who are psychiatric survivors, people who are shock survivors, allies, and MindFreedom International members filed an official complaint about the FDA processes concerning the shock device with the FDA Ombudsman Office and the Medical Devices Ombudsman.
From the conclusion of our complaint:
In short, our public complaint requests that the FDA Ombudsman Office intervene on all thirteen major issues we take with the processes FDA used/is using concerning this attempt to down-classify the shock device. Our overall requests are:
First, we do not want the shock device down-classified for any reason, but particularly the fraudulent reason that it is ’safe enough’ for people who are ‘depressed’ ‘bipolar’, ‘treatment-resistant’ or ‘require rapid response’;
Second, we want FDA to hold public accessible hearings based on the balance of this new information prior to approving the proposed rule and draft guidance;
Third, we want a complete moratorium on all shock treatment until these issues are resolved; and
Fourth, we want all of the issues publicly asserted in this complaint addressed.
You can read the full 47-page complaint here: http://laurentenney.us/public-complaint-to-fda-ombudsman-shock-device.html
We barely have 4 days left to say #FDAStopTheShockDevice. We will be submitting our comment and the petition to the FDA as late on March 28, 2016 as we can (the deadline is 11:59PM). So PLEASE sign the petition before then.
Share the petition with your networks, friends, and loved ones. If the FDA is successful, shock treatment in the United States--and around the world--will soar. Court-ordered shock treatment will become much more common.
Please speak out and help today by re-sharing this petition!
P.S. The American Psychiatric Association is telling its membership "Don’t let opposition from anti-psychiatry groups and other individuals defeat the proposal—be sure to have your voice heard."
We have to keep pushing #FDAStopTheShockDevice and make sure those in psychiatric power do not succeed in their attempts to keep the shock device on the market.
PPS The American Psychiatric Association continues with the disinformation campaign that if the FDA down-classifies the shock device it will be a "class II device (low risk)"That's a lie.
We asked the FDA Ombudsman Office holds them responsible for fraud!
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