Petition updateStop FDA from Down-Classifying the Shock Device to a Class II Device Stop shock treatment.
Don't Let Arbitrary Dates Dictate Down-Classification of Shock Device #FDAStopTheShockDevice

MindFreedom International

Apr 1, 2016
Thank you to 2,120 supporters!
I just got off the phone with Michael Ryan at the FDA.
He explained to me that even though it was arbitrary, they had to close the period for comments at some point and that FDA would not be re-opening the shock dockets, nor did he envision them holding hearings because they held hearings in 2011.
I find this unacceptable and I hope you will agree with me that we must take further actions.
After explaining to Mr. Ryan my inability to input all of the comments we received through the petition, and that documents from my own comments were not successfully uploaded, he agreed to accept these documents.
On Monday afternoon I will be sending these materials to Mr. Ryan via registered mail, return receipt requested.
This is literally the last chance to ask your networks, friends, and loved ones to have your voice counted in this round of our fight with the FDA to not down-classify the shock device for any reason, and to have them hold hearings on the shock device.
Also, as an update to this petition being shared with HHS, of all of the offices that I submitted our complaint to at HHS, only the Office of Human Research Protections has responded.
OHRP responded:
"OHRP has determined that it does not have jurisdiction over the matters referenced in your letter. Therefore, OHRP will not be able to pursue this matter on your behalf."
I called the responder and was informed for it to be in their jurisdiction, the study would need to have had HHS funding.
Next week I will start looking into each of the studies cited by the American Academy of Child and Adolescent Psychiatry and try to trace their funding. We should set up watch for any studies on shock treatment funded by HHS now and in the future and again take these issues to OHRP. If you know of any HHS-funded shock studies, please let me know.
I know we can get the attention of the Federal Government. 380 more signatures will bring us to 2500 people petitioning the government to not down-classify the shock device.
Please share and thank you for your continued support.
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