The pursuit of orphan drugs remains high and why not? The Orphan Drug Act, which encourages development of meds for diseases with small markets, gives drugmakers seven years in which to sell a product without competition for seven years and sometimes tax incentives, too. So it is not surprising that a record 323 requests for designation were submitted to the FDA last year.
And the agency's Office of Orphan Products Development obliged by designating 192 meds with orphan status. As a result, there are now 2,308 drugs with this designation, as noted by the FDA Law Blog, which scanned the FDA orphan drug database. However, the FDA approved only 14 orphan meds last year, down from 17 approvals in 2009 and down from a high of 25 back in 1996.
Why is there so much interest lately? Hard to say, although it is reasonable to speculate that FDA workshops garner attention (here's one) and, of course, the opportunity to get a lock on a market for several years is all-the-more tempting at a time when FDA scrutiny of new drugs is particularly high and drug development is so expensive.