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# Orphan Drug Designation Requests Much Higher
- URL: https://www.fdaweb.com/orphan-drug-designation-requests-much-higher/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134721

> FDA’s Office of Orphan Product Development (OOPD) received 472 requests for orphan drug designations in 2015, five more than the record-setting 467 requests in 2014\. Attorney **Kurt Karst** (Hyman, Phelps & McNamara), [writing](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2016/02/orphan-drug-approvals-dipped-in-2015-while-designations-and-designation-requests-continue-upward-tre.html?ref=fdaweb.com) in his firm’s *FDA Law Blog*, says that OOPD “designated an amazing 354 products as orphan drugs,” about a 22% increase over 2014.  
>  
> Karst notes that while the OOPD workload has increased considerably in recent years, its staff level and budget have remained relatively flat. “While OOPD is a pretty lean, mean, working machine,” he writes, “resources can be stretched only so thin. We’re already starting to see some of the strains of the increasing workload on OOPD.”  
>  
> He notes that while OOPD usually sets an internal target date for responding to orphan drug designation requests at about 60-90 days from date of receipt, it appears that the target date is now around 90-120 days.  
>  
> “Those folks in charge of the purse strings should really consider dedicating greater funding to OOPD,” Karst concludes.