February 23, 2016—Petitioner Fisher Wallace Laboratories filed an amendment to their original citizen petition. Fisher Wallace manufactures cranial electrotherapy stimulation (CES) devices, which may be used to treat symptoms of depression, anxiety, and insomnia. The original petition was filed on March 9, 2012. Petitioners requested expedited review for reclassification. Petitioners also asked for investigation of possible misconduct of organizations that made adverse recommendations to their request for expedited review, such as the Center for Devices and Radiological Health, Neurological Devices Paten of the Medical Devices Advisory Committee. In the amended citizen petition, Petitioners expands its allegations to include alleged misconduct by the FDA itself. Petitioners request that the Commissioner refer the petition to an independent investigatory body such as the Department of Health and Human Services’ Office of the Inspector General.
By Una Fan