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# Generic Policy Shop Cuts will Hurt ANDAs: Post
- URL: https://www.fdaweb.com/generic-policy-shop-cuts-will-hurt-andas-post/
- Published: 2025-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:57:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158981

Hyman, Phelps & McNamara attorney **Kurst Karst** is raising concerns about recent staff cuts at FDA that “eradicated” the Office of Generic Drugs’ Division of Policy Development (DPD). The division’s functions are critical to the development and approval of generic drugs, he says in a 4/9 *FDA Law Blog* [post ](https://www.thefdalawblog.com/2025/04/the-great-rift-one-fda-divisions-destruction-and-what-it-could-mean-for-generic-drugs/?ref=fdaweb.com)and there is uncertainty about how the work will be handled going forward. Among other functions, the division was responsible for:

- Developing product-specific guidances.
- Implementing the Drug Competition Action Plan, which focused on removing barriers to generic drug development, approval, and market entry.
- Publishing generic drug guidances and internal policies and procedures to fulfill FDA’s user fee commitments.
- Processing voluntary ANDA withdrawals.
- Managing the process of issuing Covered Product Authorizations under the CREATES Act for generic manufacturers to have access to samples of brand-name drugs not readily available through normal market channels for generic drug development.

Karst says the division also did other substantial “behind-the-scenes work” to support ANDAs and OGD generally. For example, it “worked with subject matter experts from across FDA to clarify the scientific and regulatory pathway for the transition of generic metered-dose inhalers to different propellants…,” he says. 

In closing his post, Karst says “generic drug access, availability, and affordability will suffer without DPD. We can only hope that the powers that be will promptly reconsider this move.”