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# FDA Taps Comstock Rick for Rare Disease Hub
- URL: https://www.fdaweb.com/fda-taps-comstock-rick-for-rare-disease-hub/
- Published: 2024-11-01T12:00:00.000Z
- Updated: 2026-09-14T14:45:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158106

FDA has selected former Leavitt Partners consultant **Amy Comstock Rick** to serve as strategic coalitions director for the newly created Rare Disease Innovation Hub. In this role, Rick will report directly to the hub’s co-leaders — CDER director **Patrizia Cavazzoni** and CBER director **Peter Marks** — and she will act as a single point of external engagement on “cross-cutting rare disease-related issues and will also drive the development of a comprehensive strategic agenda for the hub, according to an [agency update](https://www.fda.gov/news-events/fda-voices/fda-takes-exciting-steps-toward-establishing-rare-disease-innovation-hub?utm%5Fmedium=email&utm%5Fsource=govdelivery#:~).

FDA established the hub in July to help advance rare disease product development, particularly products intended for smaller populations or for diseases where the natural history is variable and not fully understood. It is also intended to enhance inter Center collaboration to address common scientific, clinical, and policy issues related to rare disease product development; and to advance regulatory science with dedicated workstreams for consideration of novel endpoints, biomarker development and assays, innovative trial design, real-world evidence, and statistical methods.

An earlier notice said the hub will also leverage activities of the CDER Accelerating Rare Disease Cures program and the CBER Rare Disease Program. The recent update says the hub will also “collaborate with other areas that touch rare diseases across the FDA, including with the Center for Devices and Radiological Health, the Oncology Center of Excellence, and the Office of Orphan Products Development.” This includes creating a Rare Disease Innovation Hub Steering Committee that will bring together these groups and a new CBER-CDER Rare Disease Policy and Portfolio Council, it says. The council is expected to bring together experts from the Centers to consider scientific, regulatory science, and policy issues related to rare disease product development that are common to both centers.

Rick previously served as president and chief executive officer of the Food & Drug Law Institute. She has a law degree from University of Michigan Law School and a bachelor’s degree from Bard College.