People Are Watching Us! Share the Complaint; Sign the Petition; Share the Petition Again!

The following Offices of Health and Human Services were contacted this morning to inform them of our petition and complaint and to request a meeting and intervention in getting a response to our calls for the shock dockets to be re-opened, and FDA to hold hearings on the shock devices. Please use our two additional hashtags: #FDAOpenShockDocketsBackUp and #FDAHoldShockDeviceHearings. Here are the contents of that communication: We will let you know what the results are as soon as we hear back from any of the following offices: TO: Sylvia Mathews Burwell, Secretary of Health and Human Services, scheduling@hhs.gov Karen B. DeSalvo, MD, MPH, MSc, Office of the Assistant Secretary for Health, ASH@hhs.gov, Evelyn M. Kappeler, Office of Adolescent Health, oah.gov@hhs.gov Jerry Menikoff, MD, JD, Office for Research Protections, OHRP@hhs.gov J. Nadin Gracia, MD, MSCE, Office of Minority Health, info@minorityhealth.hhs.gov Don Wright, MD, MPH, Office of Research Integrity, AskORI@hhs.gov Surgeon General, Vice Admiral (VADM) Vivek H. Murthy, MD, MBA, Office of the Surgeon General, ashmedia@hhs.gov Nancy C. Lee, MD, Office of Women's Health, nancy.lee@hhs.gov Lisa M. Lee, PhD, MS, Presidential Commission for the Study of Bioethical Issues, info@bioethics.gov Office for Civil Rights, OCRMail@hhs.gov I am hoping to schedule a meeting with you concerning the FDA processes attempts to down-classify the shock device from a Class III device to a Class II device without holding hearings. Additionally, we are requesting that the public dockets are opened back up, as many people were not able to respond within the allotted, which we did not find sufficient for genuine participation in government processes. Name: Lauren J. Tenney, PhD, MPhil, MPA, Psychiatric Survivor Mailing Address: 29 Storer Avenue Staten Island, NY 10309 Phone: (718) 273-8708, (516) 319-4295 Specific Topic for Meeting: FDA processes for attempting to down-classify shock device; our petition to FDA and HHS; our complaint to FDA Ombudsman Office Who will attend meeting: Myself and several people who are shock survivors Dates for Meeting: At your convenience, but as soon as possible. Other information: Please see below and attached documents. RE: Docket No. 2014-N-1210 “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treamtent-Resistant or Require a Rapid Response; Effective Date of Requiremnt for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses AND Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff” Please see attached our petition to FDA to not down-classify the shock device for any reason and that FDA must hold hearings on the shock device and our complaint to the FDA Ombudsman Office. I have received confirmation that our official complaint has been received by the Abiy B. Desta, Ombudsman, Center for Devices and Radiological Health, US Food and Drug Administration. However, our petition was also directed at HHS and our complaint is directed at The Public and All Elected, Appointed, And Otherwise Employed Government Employees. The FDA Dockets closed on March 28, 2015 and many people were unable to respond, as there simply was not enough time to do so. We envisioned this and had put the issue of not having enough time to reach people, process information, and comment in our complaint. I, myself, in attempting to upload over 700 comments generated on our petition did not have enough time to do so. My own, typo-filled comments, I submitted literally at 11:59PM and some of the attachments that I attempted to submit were rejected, and these included the comments of over 700 people opposing the FDA's proposed rule to down-classify the shock device. As of March 30, 2016 at 3:10 PM, 2,070 people have signed our petition. We are seeking your help in getting the shock dockets, FDA-2014-N-2010 and FDA-2014-D-1318 re-open so that the American public can have adequate time to respond and participate in government processes. Please let me know how you can assist. You can see 2,070+ people who signed the petition to say #FDAStopTheShockDevice here: https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment; You can read the full 47-page public complaint here: http://laurentenney.us/files/113651456.pdf. Thank you for your time and attention. Sincerely, Lauren J. Tenney, PhD, MPhil, MPA, Psychiatric Survivor (516) 319-4295 (cell) (718) 273-8708 (land) www.LaurenTenney.us -----Original Message----- From: Lauren Tenney To: ombuds ; cdrhombudsman Cc: laurentenney Sent: Thu, Mar 24, 2016 3:46 am Subject: OFFICIAL PUBLIC COMPLAINT RE: FDA PROPOSED RULE ON SHOCK DEVICE Hello Talisha Williams and Abiy Desta::: Ms. Williams, I spoke with you on February 24, 2016, one month ago today, about concerns people I am working with to respond to the FDA proposals to down-classify the shock device have and were hoping your office and the medical device ombudsman will address and resolve. I appreciated you listening to our concerns. You suggested we put our concerns in writing. We have done this. Therefore, I am writing on behalf of people who are psychiatric survivors, people who are shock survivors, allies, and members of MindFreedom International to submit an official public complaint concerning: Docket No. 2014-N–1210 for ‘‘Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment-Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses” and Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff”. Ideally, we would appreciate an acknowledgement of receipt of this attached public complaint with your response to this complaint prior to the close of these open dockets, which is March 28, 2016. If it is not possible to have a response included with acknowledgement by then, we ask for a full response by May 4, 2016 which ought to have been the close of the 90-day period if business days and holidays were taken into account. Please contact me for clarification, response, or any reason at (718) 273-8708; (516) 319-4295 or LaurenTenney@aol.com. Thank you for your time and attention. Lauren Lauren J. Tenney, PhD, MPhil, MPA, Psychiatric Survivor