2008 was a banner year for orphan drug designations. FDA’s Office of Orphan Products Development (“OOPD”), which, since September 2007, has been under the leadership of Timothy Coté, M.D., M.P.H., designated a record 165 products for orphan (i.e., rare) diseases and conditions. FDA also approved 15 orphan products in 2008. The 2008 orphan drug designation figure continues a recent trend in an uptick in designations. From 2004 to 2007, OOPD granted 130, 122, 141, and 119 designations, respectively. From 1983 to 2003, the greatest number of orphan drug designations in a single year was 95. The table below illustrates OOPD’s designation and FDA’s orphan drug approval track record since the enactment of the Orphan Drug Act of 1983 (“ODA”).
