> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Offers Advisory Committee Hearing on Intarcia Dispute
- URL: https://www.fdaweb.com/fda-offers-advisory-committee-hearing-on-intarcia-dispute/
- Published: 2023-02-07T12:00:00.000Z
- Updated: 2026-09-14T18:14:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153727

FDA Chief Scientist **Namandjé N. Bumpus** has proposed an advisory committee review to address a 2021 CDER decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to deliver exenatide, a GLP-1 receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

In a [2/7 letter](https://downloads.regulations.gov/FDA-2021-N-0874-0066/attachment%5F1.pdf?ref=fdaweb.com) to Intarcia’s counsel, Hogan Lovells’ **David M. Fox**, and FDA’s Office of Chief Counsel, Bumpus says she has “identified numerous disputes between the parties with respect to the NDA for ITCA 650.” She further said that a public hearing before an advisory committee could “aid in the resolution of the parties’ disputes and enable the Office of the Commissioner to render a final decision for the agency on this matter.”

When CDER rejected the NDA in 2021, it published a *Federal Register* [notice](https://www.govinfo.gov/content/pkg/FR-2021-09-02/pdf/2021-18928.pdf?ref=fdaweb.com) that outlined the following issues raised in two complete response letters:

- the clinical trial data demonstrated that the product causes acute kidney injury;
- the cardiovascular risk assessment failed to provide sufficient assurance that ITCA 650 is not associated with excess cardiovascular risk;
- the data provided to validate the limits of the in vitro dose delivery specifications did not support the safe and effective use of the device constituent in the product;
- the data provided, inclusive of delivery performance data and failure analyses, did not demonstrate adequate device reliability associated with in vitro dose delivery to support safety and effectiveness for the intended use;
- the information provided was inadequate in support of sterility assurance for ITCA 650; and
- an FDA inspection of the Intarcia manufacturing facility identified deficiencies in the manufacturing practices for ITCA 650 that were not adequately addressed.

The Bumpus letter gives Intarcia notice to respond by 2/24 to request the advisory committee hearing, which would be held before the Endocrinologic and Metabolic Drugs Advisory Committee within 120 days of Intarcia’s request or as soon as practicable. Bumpus says that if the hearing proceeds as proposed, she would render the final decision for the agency.