Maryland Sponsor-Investigator Bypasses Trial Regulations, Earns FDA Ire
An herbal medicine specialist operating trials as a sponsor-investigator has been hit with an FDA Form 483 after a March inspection found she had skipped investigational new drug (IND) approval, IRB review and informed consent in two trials for COVID-19 treatments.
Wanzhu Hou, who operates All Natural Medicine Clinic in Rockville, Md., failed to submit IND applications and receive FDA approval to conduct two trials that began in May and September 2020, an agency investigator found.
These trials, which have enrolled 31 and 17 participants, last treated participants in early 2022 with natural medicines (combination products and dietary supplements) that the FDA considers to be investigational new drugs.
The trials were still open to enrollment at the time of inspection, according to the 483, and are listed as “Recruiting” on ClinicalTrials.gov as of the date of this publication.
In addition to not having the agency’s green light, Hou did not submit written protocols and informed consent documents to an IRB for review. In fact, neither existed for the trials at the time of inspection.
By extension, the 483 also lists failure to obtain informed consent from each participant before administration of an investigational product.
There were also issues with recordkeeping in the two trials. Hou did not use any case report forms to document study data, with participant records being kept in an online electronic health record, and no records were kept related to participant eligibility.
The trials also had no investigational drug accountability records to speak of. “Detailed records documenting shipment, receipt and disposition of investigational product were not maintained,” the FDA said.
Hou could not be reached for comment.
Access the Form 483 here: https://bit.ly/3SO589U.