Petition to the FDA to reverse the approval of the vagus nerve stimulation (VNS) device for the management of treatment-resistant depression (HRG Publication #1783)
To view our request for a National Coverage Determination with the Center for Medicare & Medicaid Services, filed in conjuction with this petition, click here.
September 6, 2006
Daniel Schultz, M.D.
Dear Dr. Schultz:
Public Citizen, a consumer advocacy group with 98,000 members, hereby petitions the Food and Drug Administration (FDA), pursuant to the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 360d, 360f, and 352, and 21 C.F.R. §§ 10.30 and 861, to reverse the approval of the vagus nerve stimulation (VNS) device for the management of treatment-resistant depression (TRD) because the device has not demonstrated a “reasonable assurance that the device is safe and effective,” the standard under the law, 21 CFR 860.7(4)(c)(1).
Today, we are also filing a request for a National Coverage Determination with the Center for Medicare & Medicaid Services (CMS) in which we ask that the device not be considered appropriate for reimbursement by the Medicare program. That letter is attached to this letter and is incorporated by reference. We also incorporate by reference our letter to you of May 11, 2005 (available at: http://www.citizen.org/publications/release.cfm?ID=7385), in which we argued that the device should not have been approved in the first place.
A. Action Requested
The revocation of FDA’s prior approval of VNS for TRD
B. Statement of Grounds
We will not reiterate our arguments as to why we consider VNS ineffective for TRD, as they are reviewed in the letter to CMS as well as in our earlier letter to you. Moreover, the company has generated no significant new data since its submission to the FDA. The only new information of relevance is the report by the Senate Finance Committee on the approval process for VNS (Committee on Finance, United States Senate. Review of the FDA’s approval process for the vagus nerve stimulation therapy system for treatment-resistant depression. February 2006. Available at: http://finance.senate.gov/press/Gpress/02_2006%20report.pdf.).
The investigation concluded that, in approving VNS, you overruled the more than twenty FDA officials who had reviewed the data. Every one of them recommended against FDA approval. The report concluded further that “The facts and circumstances … raise legitimate questions about the FDA’s decision to approve that device for the treatment of TRD.” Elsewhere, the report again questions the appropriateness of FDA’s approval, concluding that “instead of relying on the comprehensive scientific evaluation of its scientists and medical officers, it appears that the FDA lowered its threshold for evidence of effectiveness.” Among the report’s more specific findings were these:
Given these highly irregular aspects of the approval process at the FDA, it is appropriate that the FDA revisit its ill-advised decision to approve VNS for TRD. To have an ineffective device on the market (and an expensive, surgically implanted one at that) does no favors for those suffering from TRD. To allow the continued marketing of this device is to perpetrate a cruel hoax on those patients.
C. Environmental Impact
The actions requested by this petition are covered by categorical exclusions from the preparation of an environmental assessment or environmental impact statement under 21 C.F.R. §§ 25.34 (c) and 25.30(k). In addition, the actions requested would not have any substantial impact on the environment.
The undersigned certify that, to the best of their knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioners, which are unfavorable to the petition.
Peter Lurie, MD, MPH
Sidney M. Wolfe, MD