FDA warns COVID trial sponsor for failing to submit IND

The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.
 
In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Subjects and Their Quarantined Close Contacts Who Test Positive for COVID-19.”
 
While the treatment investigated in the trial is redacted from the warning letter, HealthQuilt is only listed as the sponsor of one study in ClinicalTrials.gov investigating the use of Nerium oleander in patients with COVID-19 and their close contacts. Other details available in the ClinicalTrials.gov listing match those provided in the warning letter.
 
“We conclude that HealthQuilt, as the sponsor, and you, as the clinical investigator, did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects,” FDA wrote in the warning letter.
 
“HealthQuilt studied the efficacy and safety of [redacted] in subjects who had tested positive for COVID-19 or who were close contacts of subjects who had tested positive, to determine whether and to what extent [redacted] has antiviral properties, helps patients with COVID-19 recover faster, and prevents transmission of disease,” FDA added.
 
While HealthQuilt claimed the study was intended to evaluate the use of a dietary supplement, FDA explained that the product both meets the definition of a new drug and fails to qualify as a dietary supplement under FDA regulations. “Because the product was intended for the treatment, cure, and prevention of COVID-19, it meets the definition of a drug under the [Federal Food, Drug, and Cosmetic Act] FD&C Act,” FDA wrote, noting that the intervention is not generally recognized as safe and effective for the uses being investigated.
 
FDA explained in the warning letter that an IND is required before conducting a clinical investigation of a drug in human subjects except if the investigation qualifies for an IND exemption under 21 CFR 312.2(b). In this case, FDA said the investigation does not meet the criteria for an IND exemption as it does not involve a lawfully marketed drug.
 
“[O]ur intent in conducting this study was to evaluate the use of [redacted] as a dietary supplement only,” HealthQuilt wrote in its response to the Form 483 it received after the inspection. The company also said it acknowledged and deferred to the agency’s insistence that an IND was required. It did not intend to submit the results of the study in support of the product’s approval as a new drug.
 
However, FDA denied that the product could be considered a dietary supplement as it has been authorized for investigation as a new drug subject to substantial clinical investigations which have been publicly disclosed and because the product has not been previously marketed as a dietary supplement or food.
 
Furthermore, FDA said that the sublingual route of administration featured in the study would preclude the dietary supplement claim, as supplements may only be “intended for ingestion” by definition.
 
“Because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not intended for ingestion,” FDA wrote.
 
FDA also cited HealthQuilt for failing to maintain “any records showing receipt, shipment, or other disposition of the investigational drug” and for consenting subjects to the trial with informed consent forms that included a clause releasing the sponsor, investigator and others from liability for the study.
 
“No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence,” FDA wrote.
 
Lastly, FDA said that HealthQuilt failed to retain required records for at least two years after the investigation was discontinued as required under 21 CFR 312.62(c), noting that the company “failed to retain at least eight signed and dated informed consent forms.”
 
FDA