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# 2017 Orphan Drug Approvals ‘Skyrocketed’: Analysis
- URL: https://www.fdaweb.com/2017-orphan-drug-approvals-skyrocketed-analysis/
- Published: 2018-02-28T12:00:00.000Z
- Updated: 2026-09-14T23:26:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140868

Attorney **Kurt Karst** (Hyman, Phelps & McNamara) says FDA granted 476 orphan drug designation requests in 2017 and approved 77 orphan drugs. He says requests for designation and approvals both “skyrocketed” last year, “obliterating” the previous records of 49 approvals in 2014 and 355 requests in 2015.

“The increase in orphan drug designations may be attributed to FDA’s Orphan Drug Designation Modernization Plan, which targeted the elimination of the backlog of pending designation requests,” Karst [writes](http://www.fdalawblog.net/2018/02/going-strong-orphan-drug-approvals-and-designations-skyrocketed-in-2017-while-orphan-drug-designation-requests-dipped-slightly/?ref=fdaweb.com) in his firm’s *FDA Law Blog*. “FDA’s Office of Orphan Products Designation also received a near record 526 requests for orphan drug designation in 2017\. That’s a slight dip over the 2016 record of 582, but still not too shabby! Since 1983, FDA has granted more than 650 orphan drug approvals, has granted nearly 4,500 orphan drug designations, and has received more than 6,300 orphan drug designation requests.”

Karst says that additional new efforts announced by FDA could lead to records being set again in 2018\. The new initiatives include a pilot program for more efficient orphan designation requests. He notes that pilot program elements include a fillable form, an on-line tutorial to guide sponsors through the submission process, and a new inter-Center consultation process to streamline and standardize agency communications.