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# Orphan Drug Requests Way Up, Approvals Down Slightly: Attorney
- URL: https://www.fdaweb.com/orphan-drug-requests-way-up-approvals-down-slightly-attorney/
- Published: 2017-01-26T12:00:00.000Z
- Updated: 2026-09-14T22:03:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137827

Attorney **Kurt Karst** (Hyman, Phelps & McNamara) says that FDA is receiving orphan drug designation requests at a record rate of 1.6 per day, up from 2.23 per work day in 2016, and is granting designation requests at a near-record rate of 0.9 per day, down from 1.28 per work day in 2016\. Presenting his annual [roundup](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/01/orphan-drug-approvals-and-designations-dipped-slightly-in-2016-but-orphan-drug-designation-requests-.html?ref=fdaweb.com) of orphan drug designations and approvals in his firm’s *FDA Law Blog*, Karst says that in 2016 the agency’s orphan drug program “continued to break new ground with massive numbers of orphan drug designation requests.” He notes that 2016 was still the second-best year for orphan drug designations, and the third-best year for orphan drug approvals since the Orphan Drug Act was enacted.

The agency’s Office of Orphan Product Development (OOPD) received 582 requests for orphan drug designation in 2016, 110 more than the record set the previous year. OOPD granted 333 designations in 2016, 26 fewer than in 2015\. Since 1983, he writes, FDA has approved almost 600 orphan drugs, has granted nearly 4,000 orphan drug designations, and has received nearly 5,800 orphan drug designation requests.

Karst notes that funding for the OOPD has remained relatively flat, while the workload has increased considerably. “Perhaps the soon-to-be-released budget will include some much-needed additional funding for OOPD,” he writes, “but we’re not holding our breath.”