Cyberonics Faces New Hurdle

Less than three weeks away from an expected final decision from FDA on its vagus nerve stimulation (VNS) therapy system for the treatment of cases of depression considered treatment-resistant, Cyberonics Inc. (Houston) received notification from the U.S. Senate Finance Committee (SFC) that it is examining FDA’s handling of the company’s application for device approval.

SFC’s involvement was apparently sparked by Public Citizen (Washington, DC), an organization founded by well-known consumer activist Ralph Nader in 1971. In a letter to Daniel G. Schultz, MD, director of FDA’s Center for Devices and Radiological Health (CDRH; Rockville, MD), Public Citizen questioned both the effectiveness of the device and the soundness of the studies submitted by Cyberonics, and said the device should not be approved.

Peter Lurie, MD, deputy director of Public Citizen’s health research group, said, “FDA would never approve a drug under these conditions. They certainly shouldn’t approve this device.” Nicholas Stine, a researcher at Public Citizen, added, “FDA should not let justified empathy for this patient population lead to the unjustified approval of a device that does not come close to meeting the agency’s approval standards and may do more harm than good.”

Cyberonics CEO Cummins: No wrongdoing.

Acknowledging the SFC inquiry, Robert P. Cummins, Cyberonics chairman and CEO, said “Cyberonics and its advisers believe that SFC’s examination will produce no new information and will have no bearing on FDA’s final approval decision of the VNS for treatment-resistant depression.” According to Cummins, the letter from SFC “alleges no wrongdoing on Cyberonics’ part and informally requests that Cyberonics provide certain information to the committee.” Cummins indicated that the company plans to cooperate with the request.

The Senate Finance Committee, chaired by Senator Charles Grassley (R–IA) and with Max Baucus (D–MT) as ranking member, has not issued any public statement on the Cyberonics inquiry.

The VNS system was initially approved by FDA for the treatment of epilepsy in 1997. In 2003, Cyberonics sought permission from the regulatory agency to market the device for the treatment of severe treatment-resistant depression. In June 2004, the agency’s neurological devices advisory panel recommended such action in a 5–2 vote. But that recommendation was subsequently set aside by the agency, which rejected the application in August. The following month, Cyberonics submitted its premarket approval (PMA) application with supplemental information addressing specific FDA concerns.

During this same period, Cyberonics was moving to resolve issues raised in an FDA warning letter received last December regarding “nonconformities with current good manufacturing practice (CGMP) requirements of the quality system regulation for medical devices.”

In February, FDA approved the VNS for the treatment of depression but stipulated that Cyberonics could not market the device until certain conditions were met, including full compliance with GMP quality systems directives at its Houston manufacturing facility—the plant cited in the warning letter.

Public Citizen referred to FDA’s reversal as “mysterious.”

In early April, Cummins reported that the company had received notification from FDA that it was in full compliance with all quality systems requirements, that the issues raised in the warning letter were fully resolved, and that the matter was closed.

Noting that the company has satisfied the conditions of final approval of VNS for depression, Cummins said Cyberonics is “prepared for a successful launch and to accomplish its mission of improving the lives of people touched by treatment-resistant depression. We continue to make good progress towards favorable coverage policy.” Cummins also noted that the company has received significant interest from psychiatrists involved in postmarket studies, including the dosing study, patient registry, and mechanism-of-action research.

Most medtech analysts expect FDA to give the final go-ahead to Cyberonics to market VNS for the treatment of severe depression, although it may be delayed until SFC completes its inquiry. Of greater concern, however, is the potential politicization of the device approval process. The involvement of Public Citizen represents the second instance in as many months of special interest groups challenging the actions and decisions of regulatory bodies and taking their case directly to Congress. Last month, a special interest group petitioned Congress to intervene in FDA’s pending decision to approve silicone breast implants from Mentor Corp. (Santa Barbara, CA).

© 2005 Canon Communications LLC

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