The FDA has issued a warning letter to an eye center in Illinois for failing to file an investigational new drug application (IND) before initiating a trial of a combination drug-device investigational product.

The warning letter to David Lubeck of the Arbor Centers for EyeCare in Orland Park, dated Nov. 18, was sent following an FDA inspection in April which detailed “objectionable conditions” at the site, including a failure to submit an IND as required by regulations.

Specifically, the warning letter claims that Lubeck did not submit an IND to the FDA prior to starting the trial, which enrolled five participants, noting that his May 10 response to the agency’s Form 483 was insufficient.

In that response, Lubeck said that he and the institutional review board (IRB) determined that the trial protocol posed a nonsignificant risk to participants and that neither an IND nor an investigational device exemption were required.

The agency, however, noted that the investigational product has drug-device components and, therefore, must be regulated as a combination product requiring an IND, and that the FDA’s Center for Drug Evaluation and Research has primary jurisdiction over the product, not the IRB.

The FDA acknowledged that Lubeck halted enrollment and study activities after the IRB informed him that an IND was needed after all, but the IND submitted to the agency and referenced in his response did not contain the correct study protocol, instead featuring “a similar but substantively unique clinical protocol.”

The failure to have an IND approved before initiating the trial “raises concerns about the validity and integrity of data collected at your site during the conduct of the clinical investigation,” the agency said.

The Arbor Centers for EyeCare did not respond to a request for comment.

Read the FDA warning letter here: https://bit.ly/3Y4zM1N.