FDA issues Warning Letter for not complying with Clinical Trial Rules

The U.S. Food and Drug Administration (FDA) issued a Warning Letter for not complying with regulations during the clinical investigation of an investigational medicinal product (IMP) to mitigate and treat COVID-19. 

During an FDA inspection conducted from February 24 to March 3, 2021, the agency reviewed the role of a sponsor of two clinical investigations relating to COVID-19 treatments. The inspection was conducted as a part of the agency´s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of clinical trials and to help ensure that the rights, safety, and welfare of human subjects have been protected.

Failure to submit INDAs

In particular the sponsor initiated and conducted the clinical investigations without submitting an investigational new drug application (INDA). FDA regulations require a sponsor to submit, and to have in effect, an INDA before initiating a clinical investigation of an IMP in human subjects, unless the clinical investigation qualifies for an INDA exemption.

Food or Drug?

The sponsor argued that there was no obligation to submit an INDA before initiating the clinical investigations because the article under study was a food rather than a drug. To support this argument, the sponsor argued that the secondary endpoints in these studies were determinative of safety and tolerability. For this reason, the sponsor stated it was a food intervention, "and consistent with Agency guidance, it was appropriate to conduct these studies without an INDA in a population with COVID-19".

However, the FDA concluded that the evidence collected during the inspection showed that the IMP was intended for use as a drug, not as a food. The FD&C Act defines drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . .”  Based on the study design the IMP as used in these clinical investigations was a drug, because it was studied for use in the mitigation and treatment of COVID-19. Thus, before initiating the clinical investigations, the sponsor was required to submit an INDA to FDA and to have an INDA in effect.

In the response to the Form FDA 483, the sponsor stated to develop "a procedure for determining the need for an INDA when developing protocols for clinical studies in a disease population where endpoints may be viewed as diagnosing, mitigating, treating, preventing, or curing a disease". However, the "corrective action plan does not provide sufficient details about its new procedure for INDA determination", says the FDA. Thus, the agency is unable to determine whether the corrective action plan provided is adequate to prevent similar violations in the future.

On the FDA´s website you can read the full Warning Letter to Kaleido Biosciences.

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