The US Food and Drug Administration is an agency within the U.S. Department of Health and Human Services responsible for ensuring the safety and effectiveness of drugs (both human and veterinary), vaccines, medical devices, and other biological products used by humans. The agency became involved with the Judge Rotenberg Center after the graduated electronic decelerator was invented in 1989.

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1994

 

December 5, 1994: The FDA approved the GED shock device to be used on disabled people for the treatment of self-injurious behavior at the Judge Rotenberg Center (1).

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2000

 

January 31, February 1, 3 & 10, 2000-The FDA conducted an inspection of the JRC as a result of a consumer complaint alleging that the GED’s being used often malfunction (2).

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February 14, 2000-The FDA sent Matthew Israel the report from its inspection, and it incorrectly stated that the JRC qualified for exemption from registration of the GED-3a and GED-4. This mistake would not be realized until 2011 (2, 3).

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2010

 

November 9, to 23, 2010-The FDA inspected the JRC and found that the GEDs had been modified and made stronger and that they were being used for non-self-injurious behavior (3).

 

December 3, 2010-The JRC responded to the FDA, but failed to provide any of the evidence or documentation the FDA required (3) 

 

2011

 

May 23, 2011-The FDA finally realized it told the JRC that the GED-3a and GED-4 were exempt from registration and told the JRC that the newly modified GEDs were in violation of FDA regulations. The JRC had to file a new application for approval and was given 30 days to respond with an explanation of how they addressed or planned to address all of the violations (3).

 

July 13, 2011-People from the JRC met with the FDA at the New England Regional FDA Office to discuss the violations and need for the JRC to comply with FDA regulations (4).
 

2012

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June 29, 2012-The FDA notified the JRC, for a second time, that the GED-3a and GED-4 were incorrectly exempted from registration and required a new application (4).

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December 6, 2012-The FDA notified the JRC, for a third time, that the GED-3a and GED-4 were incorrectly exempted from registration and required a new application (5).

 

December 21, 2012- The JRC responded to the FDA and assured them that they were making progress (5).

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2013

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January 9, 2013-The FDA and JRC met to discuss submitting new notices for the GED, the transition to stop the use of the shock devices, and the physical and emotional harm that would come from not using the GEDs on disabled people (page 61. 6).

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January 15, 2013-The New York State Education Department issued the JRC a corrective action letter stating that the facility can no longer use the GED on students from New York State because the GED-3a and GED-4 have not been cleared by the FDA (7).

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March 12, 2013-New York State Education Department sent the JRC a letter giving them 30 days to stop the use of the GED on New York students because it has not been approved by the FDA (7).

 

April 13, 2014-Gregory Miller, a former teacher at the Judge Rotenberg Center, started a petition on Change.org for the FDA to ban the use of shocks on autistic and disabled people. To date, there are over 396,155 signatures (8).

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2014

 

April 24, 2014-The Neurological Devices Panel of the Medical Devices Advisory Committee to the Food and Drug Administration held a public hearing to decide if the GED should be banned. They heard the opinions of former JRC students who had experienced electric shock as “therapy”; clinical and scientific experts; disability and human rights organizations; and concerned citizens (9, 10).

-Full transcript of Open Public Hearing of the Medical Devices Advisory Committee, Neurological Devices Panel

-FDA Executive Summary prepared for the Neurological Device Panel

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April 25, 2014-The FDA releases the summary of the neurological devices panel meeting (11).

      My summary of the summary:

 

1. When the FDA asked the panel if treatments other than the GED (pharmacological, behavioral, alternative, and experimental therapies) were adequate in treating self-injurious and aggressive behavior, the panel did not believe those other treatments were adequate because there isn’t enough data regarding efficacy and long-term effects(11).

 

   2. Regarding the risk of illness and injury from the GED, some panel members didn’t feel there was enough evidence               showing that electric shocks are beneficial for self-injurious or aggressive behavior(11).

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      The FDA identified the following adverse side effects:

• Negative emotional reactions or behaviors

• burns and other tissue damage, 

• anxiety, 

• acute stress/PTSD, fear and aversion/avoidance, 

• pain/discomfort, 

• depression (and possible suicidality), 

• substitution of other negative behaviors (including aggression), 

• psychosis, and 

• neurological symptoms and injury (11).

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      The panel felt this list was incomplete and the terms were too vague. They added

• equipment malfunction, 

• long term effects of pain, 

• range of pain, 

• trauma from falls, 

• mistrust of providers, 

• learned helplessness, 

• chronic stress, 

• generalized behavioral suppression, 

• small repetitive damage of other tissues, 

• cognitive impairment, 

• neuropathy, 

• neuropsychiatric symptoms and emotional sequelae, and

• staff growing overly dependent on administering shocks for any behavior (11).

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   3. When the FDA asked the panel if the GED presents “an unreasonable and substantial risk of illness or injury”, the                 majority of the panel said that it did (11).

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   4. When the FDA asked the panel if placing some restrictions on the GED device and its use might correct or mitigate             the “unreasonable and substantial risk of illness or injury”, the panel stated that there were no restrictions that could             correct these things. The panel recommended that only licensed health professionals should administer shocks and             the device should only be used on people who engage in life-threatening self-injurious behavior (11).

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   5. When the FDA asked the panel if the GED should just be banned for only future JRC students or be completely                   banned, the majority of the panel believed that every GED device should be banned. The panel suggested that                     students who were being shocked at the time be transitioned to another treatment using a less powerful shock                     device (11).

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   6. The FDA asked the panel if a clinical study should be conducted if they decide not to ban the GED, and the panel                 stated that the studies be carried out on animals first, then adults, then children (11).

       -Summary of the Neurological Devices Panel Meeting. April 24, 2014

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2016

 

April 22, 2016-The FDA proposed a ban on skin shock devices because they present an “unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling”. The agency arrived at this decision after it considered all available clinical and scientific data, the findings from the 2014 FDA advisory panel, and opinions from experts in the field, from state agencies, and disability rights organizations; former JRC students and parents; and people working for the JRC. The FDA was concerned with the numerous physical and psychological risks associated with electronic shock devices and issues regarding consent and the possible inability for staff to understand when individuals with developmental or intellectual disabilities, or those who are nonspeaking, are in pain. The FDA believed positive behavioral support and medication would be more useful at curbing self-injurious or aggressive behaviors (12). 

 

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2018

 

March 9, 2018-The FDA still hadn’t finalized the ban, so disability activists from all over the country occupied a park in DC near the chairman of the FDA, Scott Gottlieb’s house. It was organized by American Disabled for Attendant Programs Today (ADAPT) and lasted 12 days (13). 

 

March 20, 2018-Twelve protesters occupied the FDA headquarters in Silver Springs Maryland and were arrested for blocking traffic (14).

 

April 23, 2018-The Autistic Self Advocacy Network wrote to the FDA, the Department of Health and Human Services, and the Office of Management and Budget petitioning for the ban of electric shock devices. It was signed by 240 organizations, including ACLU, NAACP, NAMI, ADAPT, Autism Society of America, Center for Disability Rights, The ARC, Down Syndrome Alliance, Families of Children on the Autism Spectrum (FOCAS), National Association of Councils on Developmental Disabilities, National Association of State Directors of Special Education (NADSE), National Association of the Deaf (NAD), National Council on Independent Living Washington DC, National Disability Rights Network, National Down Syndrome Society, National Organization of Nurses with Disabilities, Native American Disability Law Center, Inc., TASH, Teaching Learners with Multiple Needs/Ahern TEC, United Cerebral Palsy, National Council on Independent Living, and the National Disability Rights Network (15).

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October 17, 2018-The director of the FDA, Scott Gottlieb, announced his intent to finalize the ban on the GED (16).

 

2020

 

March 4, 2020- The FDA announces it would be banning the GED, starting in 30 days. The final rule was published on March 6, and was meant to take effect on April 6, 2020. JRC physicians were instructed to make a plan regarding transitioning the students off of the GED by September 2, 2020. The final report was published on March 6, 2020 (17).

 

March 27, 2020-The FDA filed a partial stay on the GED ban which allowed the JRC to continue to shock the 55 JRC student who had the GED in their treatment plan for the duration of the COVID pandemic or when the JRC’s petition to overturn the ban finishes litigation (18).
 

2021

 

July 6, 2021-The Washington D.C. Circuit Court of Appeals overturned the FDA’s ban on the GED because the Federal Food, Drug, and Cosmetic Act did not allow the FDA to have the authority to interfere with the practice of medicine (19).

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2022

 

In December 2022, the Federal Food, Drug, and Cosmetic Act was modified giving the FDA the authority to ban medical devices like the GED (20).

 

2024

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March 2024-The FDA issued a new ban on the GED shock device and says it will issue a formal ruling later this year (20).