The FDA has handed down a pair of warning letters to the New York State Psychiatric Institute and a physician-researcher who used to work there.
The letters pertain to the protection of human subjects, and closely follow controversy surrounding research that had been led by psychiatrist Bret Rutherford, MD.
It was previously reported that a participant in a clinical trial of the Parkinson’s drug levodopa for depression committed suicide, and that the trial was subsequently suspended.
Now, the FDA warning letters have shed light on agency inspections of the psychiatric institute’s institutional review board (IRB) and at Rutherford’s clinical site.
In addressing the New York State Psychiatric Institute, which is based at the Columbia University Department of Psychiatry in New York City, FDA officials indicated that the facility’s IRB did not adhere to statutory requirements governing the protection of human subjects.
The IRB failed to prepare, maintain, and follow written procedures for ensuring prompt reporting — including to the appropriate institutional officials and the FDA — according to the letter.
For instance, on August 9, 2021, at a convened meeting, the IRB determined that a serious adverse event (SAE) of death by suicide was an unanticipated problem involving risks to human subjects, the letter stated. However, the IRB did not report this to the FDA.
Other instances not reported to the agency included that, on February 7, 2022, the IRB reviewed and discussed serious noncompliance by an investigator related to medication tapers being conducted without being part of an IRB-approved protocol, the letter added. And on July 11, 2022, the IRB determined that an investigator’s failure to report an SAE to the IRB, to consistently establish or document eligibility, and to conduct all required assessments, was serious and ongoing noncompliance.
Furthermore, the IRB failed to review proposed research during convened meetings at which a majority of its members — including at least one member whose primary concerns were in nonscientific areas — were present, the letter continued.
In the agency’s letter to Rutherford, FDA officials wrote that the psychiatrist failed to ensure that a clinical investigation was conducted according to an institutional plan.
Though specific identifiers were omitted from the publicly posted letter, it pointed to several enrolled subjects who were on antidepressant treatment at the time of a screening assessment and did not undergo a protocol-required medication tapering and washout period.
Specifically, the subjects did not remain off their antidepressant medication for five elimination half-lives or 2 weeks — whichever was longer — before randomization, the letter stated.
Ultimately, the FDA noted in both letters that these were not intended to be an all-inclusive list of deficiencies.
The New York State Psychiatric Institute and Rutherford were provided 15 business days from receipt of the respective letters to notify the FDA of actions they have taken or plan to take regarding any violations, according to the documents. Failure to address the matter could result in regulatory action.
In an email, a spokesperson for the psychiatric institute provided MedPage Today with the following remarks: “The New York State Psychiatric Institute is fully committed to protecting the health and safety of all participants in programming. While we cannot comment on an ongoing review, we will continue to work with the FDA regarding this matter.”
For his part, Rutherford is no longer a faculty member of Columbia’s psychiatry department, and is no longer employed at the New York State Psychiatric Institute. He did not immediately respond to MedPage Today’s request for comment.
![author['full_name']](https://clf1.medpagetoday.com/media/images/author/Jennifer_Henderson_Photo_188.jpg)
Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.
>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/special-reports/features/109469
