The letter is addressed to psychiatrist Bret Rutherford, MD, who was the clinical investigator during the FDA’s investigation, which happened between Dec. 19 and Jan. 10. The agency said a trial at the New York City-based hospital failed to follow protocols for investigational drug studies.
Criteria said subjects who received antidepressants, antipsychotics or mood stabilizers within the past four weeks are ineligible for the research. This was not obeyed, the FDA said, as medication tapering was not followed.
The letter said Dr. Rutherford acknowledged the oversight in a Jan. 27 letter to the agency, adding that no patient harm was identified. It also listed corrective and preventive actions, including retraining all investigators and other staff.
The FDA found deficiencies in the response.
“Your written response does not provide sufficient details about how you, as a sponsor-investigator and clinical investigator, will ensure adequate oversight of study procedures,” the warning letter said. “We are also concerned that most of the corrective actions taken, appear to represent the actions of [New York State Psychiatric Institute] and do not reflect corrective actions that you have personally taken to prevent similar violations in the future.”
Becker’s has reached out to the center for comment and will update this article if more information becomes available.
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