Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.
The FDA reported in December 2019 that it had proposed a class III designation for CES devices, allowing sponsors 180 days to complete a PMA or product development protocol filing. This latest development harkens back to an FDA advisory committee hearing in 2012 that was chock full of irregularities, including an advisory panelist’s departure from the hearing room to obtain additional information, a practice that is ordinarily frowned upon by the agency.
The citizen petition noted that the FDA had proposed to require PMA filings for CES devices in August 2011, and that Rep. Carol Maloney (D-N.Y.) had penned a June 3, 2013, letter to then-FDA commissioner Margaret Hamburg regarding the irregularities surrounding the advisory hearing. The company met with several members of the FDA staff in March 2014, during which Nancy Stade, then the agency’s deputy director of policy, had acknowledged that there were problems with the classification process.
The FDA staff present at that meeting, physically or by phone, vowed to take “corrective action,” according to the petition, and an FDA regulatory adviser followed that in June 2014 with a letter that requested that Fisher Wallace withdraw a citizen’s petition regarding the classification process. Michael Ryan, whose letter was appended to the petition, wrote on June 11, 2014, that the agency was withdrawing its proposal to classify the devices as class III items, and that a withdrawal of the petition would speed up the process of designating CES devices as class II devices.
FDA says yes does not always mean yes
The agency then went back on that promise in January 2016, however, without citing any new evidence to support the about-face from the agency’s stated position two years earlier. Fisher Wallace then re-filed its citizen petition, claiming that the process had been unduly influenced by Peter Lurie, who was with Public Citizen prior to taking the role of senior adviser at the FDA’s device center.
Lurie was subsequently promoted to associate commissioner for public health strategy and analysis, and is the author of a letter included in the Fisher Wallace petition. That March 14, 2012, letter from Lurie to FDA senior adviser Daniel Sigelman says that the Center for Devices and Radiological Health “does have one friend in its treatment of CES devices.” That individual was Sidney Wolfe, who Lurie said, “can usually be relied upon to oppose any corporate position.” Wolfe, who at the time was the director of Public Citizen, is said to have “strongly urged” CDRH director Jeff Shuren to “hold fast to the center’s class III decision,” adding that Wolfe’s response to allegations that the Public Citizen’s position was legally flawed was that Public Citizen had based its position on publicly available materials.
In 2017, Lurie resigned from the agency subsequent to an investigation of his activities in connection with the CES reclassification effort, which was conduced by the office of Scientific Integrity (OSI). However, Fisher Wallace noted that the procedural irregularities predated Lurie’s time at the FDA.
The petition says at the outset that the FDA does not require clinical testing for electroconvulsive devices used for catatonia, major depressive disorders, or for treatment of patients who suffer from conditions that require a rapid response. Fisher Wallace said data regarding CES devices that employ direct rather than alternating current were not included in the panel pack for the 2012 advisory meeting, but that these devices are now part of the proposed order for class III. The company petitions that the FDA withdraw the final order and convene an advisory hearing or reconsider the evidentiary base and issue an order providing a class II designation.
Process still at the bottom of the controversy
Kelly Roman, co-founder and CEO of Fisher Wallace, told BioWorld, that the exclusion of evidence regarding direct-current (DC) devices for depression was a “strange and unusual step,” one which Roman said was without precedent. “it’s always challenging to contest a final order” by the FDA, he said, adding that the central issue is not the determination so much as the process. In the absence of an explicit and public consideration of the evidence surrounding DC CES devices, Fisher Wallace remains skeptical of the FDA’s intent to consider the data for DC devices. “In the meantime, we’re going to try to bring as much awareness to the situation as possible,” Roman said.
The FDA declined to make a spokesperson available for comment, stating that the agency does not generally comment on citizen petitions. When asked whether this was a formal policy, FDA spokesperson Jim McKinney said only that the FDA “generally … responds to the petitioner when it comes to citizen petitions.”