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# CDER Made ‘Erroneous Statements’ to A/C: Letter
- URL: https://www.fdaweb.com/cder-made-erroneous-statements-to-a-c-letter/
- Published: 2023-10-25T12:00:00.000Z
- Updated: 2026-09-14T14:14:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155645

Three former senior Intarcia Therapeutics employees who were closely involved in the development of the company’s ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes, say CDER made “erroneous statements” in a “misleading” presentation to the 9/21 meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee that [voted](https://fdaweb.com/login.php?sa=v&aid=D5155396&cate=&stid=%241%24pG4.8R1.%24oPOkVb5xbpyHO7P40ylr41&ref=fdaweb.com) 19-0 not to recommend approval of the product. In a 10/10 [letter](https://downloads.regulations.gov/FDA-2021-N-0874-0081/attachment%5F1.pdf?ref=fdaweb.com) to FDA chief scientist **Namandjé Bumpus**, the three say they are no longer employed by the company and are contacting the agency as private citizens who have no financial interest in the company or the product.

“We are submitting this information voluntarily to try to correct the record and provide you with an accurate understanding of how the product works,” the three write. They say they are concerned beyond the advisory committee meeting with how CDER managed the NDA review of the product. “This includes stating wrong information, being biased, avoiding any dialog to fully understand the device principles of operation, and not applying a science- and data-driven approach with respect to evaluation of the device performance,” they write.

The letter gives examples of what the writers say were hypothetical data and misleading erroneous statements that CDER staff made at the committee meeting. It also says the staff mixed up daily IVR acceptance criteria for one study with IVR weekly specifications. As a result, it says, “the overall conclusions on device performance stated by CDER in the \[advisory committee meeting\] are misleading and wrong.”

The three say they have been unsuccessful in trying to talk with CDER staff over an extended period to educate the staff on the basic principles of the ITCA 650 technology, and to correct the false CDER statements about the device’s performance in agency communications. “CDER has remained silent, avoided any scientific dialog, and instead produced their own misleading and wrong data and statements,” the writers state…. “One should expect FDA to apply highest standards to their work, be unbiased and science- and data-driven, and operate with a high level of integrity in the interest of public health. This is not the case for how FDA has handled the ITCA 650 ANDA. We do not know the reasons for this but are requesting to meet with you to share our concerns and provide evidence for our statements.”

A briefing document issued before the advisory committee meeting said the agency had repeatedly communicated to the company its assessment that the drug-device combination implantable product’s benefits did not outweigh its risks. The agency said a 3/9/2020 complete response letter recommended that Intarcia redesign the product so that it provides a reliable and clinically appropriate exenatide release over the life of the product. It also called for new clinical tests to demonstrate the efficacy and safety of any redesigned product.

Following a CDER 7/9/2020 proposed order to deny approval of the NDA, the company requested a public hearing before an advisory committee, which was held on 9/21.