The increasing cry for lower health care costs usually includes an emphasis on wider use of generic drugs, but some data from the FDA suggests it will take longer for US payers and consumers to reap the benefits because approval times are lagging - creating a large backlog of Abbreviated New Drug Applications.
The median NDA approval time by the agency's Office of Generic Drugs rose about five months – to 26.70 months – in fiscal year 2009 compared with 21.65 months in fiscal year 2008. Yet the number of ANDA's received is remaining fairly steady - 766 in fiscal year 2005, 880 in fiscal year 2007 and 859 in fiscal year 2009.
As a result, a backlog is festering - from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, according to OGD data presented at the recent Generic Pharmaceutical Association meeting, the FDA Law Blog writes.
In a speech, FDA commish Margaret Hamburg laments the fact that "the unprecedented spike in generics applications has simply outstripped our capacity to properly review." She goes on to press the case for generic drug makers to pay user fees, something brand-name drug makers do. The proposed White House budget request calls for about $38 million in fees from companies, and the FDA estimates mean times would be cut in half (see this). And the generic trade group, as the FDA Law Blog notes, appears willing to negotiate fees (see this). What do you think?
Should generic drug makers pay user fees, too?
- Yes (90%, 175 Votes)
- No (10%, 20 Votes)
Total Voters: 195
Hat tip to the FDA Law blog