FDA Warns COVID-19 Trial Sponsor for Failing to Submit Investigational New Drug Application
The FDA has issued a warning letter to HealthQuilt, the sponsor of a clinical trial evaluating a drug product as a COVID-19 treatment, citing its failure to submit an Investigational New Drug (IND) application for the product being studied, among other problems.
The FDA took issue with the sponsor’s characterization of the trial drug as a dietary supplement, making clear that it did not meet the definition for a dietary supplement and required an IND application because the agency considers it to be a new drug. The application was not submitted by the sponsor prior to beginning the trial as required, the agency said.
Though the name of the trial drug was redacted from the agency’s warning letter, it is presumably nerium oleander, a highly toxic plant, according to the only study HealthQuilt is listed as sponsoring on ClinicalTrials.gov. That trial, which is still listed as enrolling participants by invitation and expects to enroll up to 100 COVID-19-positive patients, is evaluating the effect of a proprietary extract of nerium oleander on COVID-19 symptoms and mortality in infected patients and their close contacts.
In addition, the FDA wrote up Houston, Tex.-based HealthQuilt for failing to maintain adequate records for the trial drug. The agency found that it failed to keep any records that showed receipt, shipment or other disposition of the drug. It also cited the sponsor’s failure to retain at least eight signed and dated informed consent forms. The informed consent forms themselves were in violation of FDA regulations as well because they included terms that waived liability for the trial sponsor, the trial drug manufacturer and others involved in the trial.
“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,” the agency clarified.
HealthQuilt could not be reached for comment.
Read the FDA’s warning letter here: www.fdanews.com/03-03-21-KDunnAssocWL.pdf. — James Miessler