Trial Site Draws FDA Warning Letter Over Combination Product

The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product.

The warning letter to David Lubeck of the Arbor Centers for Eye Care in Orland Park, dated Nov. 18, was sent following an FDA inspection in April which detailed objectionable conditions at the clinical site. 

“There are no FDA records to indicate that you submitted an IND before initiating and conducting this clinical investigation, in which five human subjects were enrolled,” read the letter, which deemed Lubeck’s May 10 response to the Form 483 lacking.

In his response, Lubeck said that he and the study’s institutional review board (IRB) determined that the study protocol posed a nonsignificant risk and that an investigational device exemption was not required.

But the FDA noted that the product involves 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 stopped study activities after “learning from the IRB that an IND was required to be submitted to the FDA,” 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 submit and to have in effect, an IND before initiating a clinical investigation “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 Eye Care did not respond to a request for comment.

Read the FDA warning letter here: www.fdanews.com/11-30-22-WarningLetter.pdf. — Jason Scott