FDA

FDA warns investigator for violating clinical hold

The US Food and Drug Administration (FDA) earlier this month warned Faro Owiesy, a physician and clinical investigator at the California-based Corona Doctors Medical Clinics, for violating a clinical hold and administering an investigational drug to patients before an investigational new drug (IND) application went into effect.

The warning letter comes after FDA inspected the clinic over six days in June as part of the agency’s bioresearch monitoring program and nearly a year after the agency placed a clinical hold on a study being conducted at the site.

“From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated July 3, 2018, we conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects,” FDA writes.

However, it is not clear who the sponsor of the clinical investigation is or what drugs were used as those details have been redacted from the warning letter.

Warning Letter

FDA says it informed Owiesy that a study under an IND he submitted was being placed on full clinical hold during a teleconference on 10 August 2017 over “insufficient information to assess risks to human subjects.”

FDA also says it sent Owiesy a letter the following month reiterating that no studies under the IND in question could be initiated, and rejected Owiesy’s request to remove the clinical hold in November as his response did not address all the issues raised in the letter.

However, FDA says Owiesy ignored the clinical hold and “administered the investigational drug [to one patient] only a few hours after the teleconference.” In total, FDA says Owiesy administered the investigational drug to six patients between the teleconference and when it sent the follow up letter.

FDA also cites Owiesy for administering an investigational drug to patients without an active IND. Under FDA regulations, an IND does not go into effect until 30 days after it is received by FDA unless the agency says it may proceed before then.

According to FDA, Owiesy administered the investigational drug to a patient just four days after submitting the IND on 17 July 2017, and to another patient on 3 August 2017.

FDA


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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