Bill Text: NJ SR122 | 2018-2019 | Regular Session | Introduced
Bill Title: Respectfully urges FDA to finalize rule banning electrical stimulation devices used in treatment of aggressive or self-injurious behavior.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Introduced - Dead) 2019-01-24 - Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee [SR122 Detail]
Download: New_Jersey-2018-SR122-Introduced.html
Sponsored by:
Senator LINDA R. GREENSTEIN
District 14 (Mercer and Middlesex)
Senator NILSA CRUZ-PEREZ
District 5 (Camden and Gloucester)
SYNOPSIS
Respectfully urges FDA to finalize rule banning electrical stimulation devices used in treatment of aggressive or self-injurious behavior.
CURRENT VERSION OF TEXT
As introduced.
A Senate Resolution respectfully urging the federal Food and Drug Administration to finalize its rule banning the use of electrical stimulation devices in the treatment of aggressive or self-injurious behavior.
Whereas, Section 512 of the federal "Food, Drug, and Cosmetic Act" 21 U.S.C. 360f, authorizes the federal Food and Drug Administration (FDA) to ban a medical device if it finds, based on all available data and information, that the device presents an unreasonable and substantial risk of illness or injury to patients; and
Whereas, In March 2010, and again in January 2013, concerned citizens and advocacy organizations urged the FDA to use its authority, under the "Food, Drug, and Cosmetic Act," to ban electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior, particularly in individuals with intellectual or developmental disabilities; and
Whereas, On April 24, 2014, the FDA held a day-long hearing on this issue, and it convened an advisory panel to seek expert opinions on the risks and benefits associated with the use of ESDs in the treatment of aggressive or self-injurious behavior; and
Whereas, The FDA considered nearly 300 public comments in association with its April 2014 hearing on this issue; and
Whereas, In April 2016, two full years after the FDA held its hearing and established its advisory panel, the agency issued a rule proposal, at 81 FR 24386, proposing a ban on ESDs used in the treatment of aggressive or self-injurious behavior; and
Whereas, In its rule proposal, the FDA concluded, based on its review of all available data and information, that ESDs pose a "substantial and unreasonable" risk of injury or illness to patients when used to treat aggressive or self-injurious behavior, and that this risk cannot be reduced or eliminated through proper device labeling; and
Whereas, The FDA found, in particular, that the use of ESDs to control aggressive or self-injurious behavior may ultimately cause the patient to exhibit numerous negative physical and psychological side effects, including, but not limited to, pain, burns, tissue damage, heart palpitations, seizures, nerve damage, loss of sensation and numbness, migraine headaches, memory loss, muscle cramps, nightmares, flashbacks, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, difficulty concentrating, depression, fear, panic, loss of interest in usual activities, post-traumatic stress disorder, acute stress disorder, shock stress reaction, learned helplessness, suicidal ideation, severe psychological trauma, catatonia, an increase in escape and avoidance behaviors, impaired brain function due to stress, the substitution of the treated behavior with other negative behaviors, such as willful immobility, and the worsening of underlying symptoms, such as increased levels of aggression or frequency of self-injury; and
Whereas, The FDA also found that there are additional risks associated with the misapplication or mechanical failure of ESDs, particularly when such devices are used on individuals with intellectual or developmental disabilities who may have the inability to indicate pain or accurately describe any increase in pain, or any unusual sensations they are feeling; and
Whereas, Although the FDA's rule proposal initially called for a public comment period of 30 days, the FDA received several requests for, and ultimately granted, a 60-day extension of the comment period, concluding that a 60-day extension would allow "adequate time for interested persons to submit comments without significantly delaying rulemaking on this important issue;" and
Whereas, On June 1, 2016, nearly 200 concerned advocacy organizations signed a letter to the FDA, as well as to the United States Department of Health and Human Services, and the federal Office of Management and Budget, in which they strongly opposed the FDA's extension of the comment period for the proposed ESD ban; highlighted the significant length of time that the FDA had already spent reviewing this issue; and urged the Obama Administration to take all necessary actions to prioritize the finalization of this rule and ensure its final publication by October 31, 2016; and
Whereas, Despite the fact that the extended public comment period ended more than two years ago, on July 25, 2016; despite the concerns raised by numerous concerned citizens and advocacy organizations; and despite the FDA's own findings and apparent recognition of the fact that there is a need to act expediently in this area, the FDA has not yet issued its final rule officially banning ESDs in the treatment of aggressive or self-injurious behavior; and
Whereas, By adopting a persistent course of delayed action on this issue, and failing to finalize its proposed rule banning ESDs in the treatment of aggressive or self-injurious behavior, the FDA has failed to fulfill its duty to protect the public health and welfare from dangerous medical devices, as provided by the federal "Food, Drug, and Cosmetic Act," and it has, instead, enabled the continued use of a device that is known to be dangerous, effectively acquiescing to the ongoing harms that are being committed therewith against some of the most vulnerable members of society; now, therefore,
Be It Resolved by the Senate of the State of New Jersey:
1. This House respectfully urges the federal Food and Drug Administration to immediately publish its final rule banning electrical stimulation devices that are used to treat aggressive or self-injurious behavior, particularly in individuals with intellectual or developmental disabilities.
2. This House further urges the federal Department of Health and Human Services to take all necessary and appropriate actions to facilitate and otherwise ensure the Food and Drug Administration's immediate publication of its final rule banning electrical stimulation devices that are used to treat aggressive or self-injurious behavior.
3. Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Clerk of the General Assembly to the Secretary of the federal Department of Health and Human Services, the Director of the Food and Drug Administration, the President of the United States, and every Congressional representative elected from this State.
STATEMENT
This bill would respectfully urge the federal Food and Drug Administration (FDA) to immediately publish, and the federal Department of Health and Human Services to take action to facilitate the immediate publication of, the FDA's final rule banning electrical stimulation devices (ESDs) that are used to treat aggressive or self-injurious behavior, particularly in individuals with intellectual or developmental disabilities.
The federal "Food, Drug, and Cosmetic Act" authorizes the FDA to ban a medical device if it finds, based on all available data and information, that the device presents an unreasonable and substantial risk of illness or injury to patients. In April 2016, two years after it conducted a public hearing and established an advisory panel to evaluate the risks and benefits of ESDs, and six years after the issue of ESD safety had first been raised with the FDA, the FDA published a proposed rule to ban ESDs in the treatment of aggressive or self-injurious behavior on the basis that these devices pose a "substantial and unreasonable" risk of injury or illness to patients when used to treat aggressive or self-injurious behavior - a risk that cannot be reduced or eliminated through proper device labeling. The FDA found, in particular, that the use of ESDs to control aggressive or self-injurious behavior may ultimately cause the patient to exhibit numerous negative physical and psychological side effects. It further found that there are additional risks associated with the misapplication or mechanical failure of ESDs, particularly when such devices are used on individuals with intellectual or developmental disabilities.
Nevertheless, despite the fact that the public comment period on the proposed rule ended more than two years ago, on July 25, 2016; and despite the FDA's own findings on the dangerousness of ESDs in the treatment of aggressive or self-injurious behavior and the agency's recognition of the need for timely action in this area, the FDA has not yet issued its final rule officially banning ESDs in the treatment of aggressive or self-injurious behavior. By failing to adopt the final rule, and instead adopting a persistent course of delayed action on this issue, the FDA is neglecting its obligations to protect the public health and welfare from dangerous medical devices, and it is, instead, enabling the continued use of a device now known to be dangerous, effectively acquiescing to the ongoing harms that are being committed with this device against some of the most vulnerable members of society. It is, therefore, imperative that the final rule be published as soon as possible.
