FDA 2008 NCE appros exceed expectations

Having made a slow start to 2008, and giving a number of excuses for its slowness of action, the US Food and Drug Administration seemed to move  into top gear towards the end of the year, making dozens of decisions  on the approval of New Chemical/Molecular Entities. However, not all of  these were positive for the applicants (see also product pages in this  issue).

In total, last year saw the FDA clear 24 New Drug Applications for  novel compounds. This compares with 18 in 2007, 22 in 2006 and 20 in  2005. As well as these, the agency approved a large number of new  indications and formulations for existing drugs.

As of end October 2008, the FDA had delayed 15 NDAs under the  Prescription Drug User Fee Act, despite payments from drugmakers that  were supposed to speed up the process, as well as a substantial budget  increase from Congress following the Act's renewal the previous year to  recruit additional reviewers (Marketletters passim). The agency argued  that problems filling new positions and delays as newcomers settled in  were to blame. Also, there is a requirement for all new drugs to be  reviewed by advisory committees made up of outside experts.