View our request for a National Coverage Determination with the Center for Medicare & Medicaid Services, filed in conjuction with this petition.
Daniel Schultz, M.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
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: https://www.citizen.org/our-work/health-and-safety/articles/letter-urging-against-approval-vagus-nerve-stimulator-treatment), 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: https://www.citizen.org/sites/default/files/02_2006_report.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:
- On October 3, 2003, CDER officials notified CDRH that had a sponsor submitted to CDER data similar in quality to those submitted for VNS, the CDER would not even have allowed the filing of the New Drug Application.
- When you were director of the Office of Device Evaluation, you ordered staff to issue a Major Deficiency Letter (instead of the non-approvable letter the staff favored) without even reviewing the sponsor’s data. The letter was sent on March 4, 2004.
- An advisory committee meeting took place on June 15, 2004, despite the objections of FDA staff, and was described by the committee’s executive secretary as “very unusual, emotional, not data driven.” The committee recommended device approval in a 5-2 vote.
- After the August 11, 2004, non-approvable letter, the FDA received hundreds of letters and phone calls urging the agency to approve the device.
- FDA relations with the sponsor were described in the report as “not collegial.” FDA staff described such interactions as “terrible” and at times “abus[ive].”
- Certain key management staff and reviewers were excluded from a critical meeting between FDA staff and the sponsor in December 2004.
- On January 6, 2005, one month prior to the approvable letter, the entire review team, including the new director of the Office of Device Evaluation, recommended against approval. The director of the Office of Device Evaluation is not typically involved in device approval decisions.
- Typically, device approval decisions are made at the division level and signed at the office level (the next level up). In this case, the decision was made at the center level in CDRH (the next step up from the office level).
- Several FDA staff, including you, agreed that the CDRH director was involved “very rarely” in decisions regarding device approval.
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, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group