As we are in the midst of approval for PDUFA IV, there has been a lot of talk from the FDA about the need for increased funds to bring greater focus on drug safety and even monitoring of marketing activities.
But if you look at the track record over the span of all the PDUFAs, one sees a curious thing. As PDUFA dollars go up, the enforcement actions by the Division of Drug Marketing Advertising and Communications (DDMAC) have gone down.
We have gone from a high in 1998 of 156 Warning Letters to the all time low set last year with 22. For the first quarter of 2007, DDMAC issued a paltry 4 Warning Letters, which amounts to an annualized rate of 20 if that trend keeps up for 2007.
YEAR # OF DDMAC WARNING LETTERS
2007 4 (first quarter only)
2006 22
2005 29
2004 23
2003 25
2002 28
2001 64
2000 75
1999 108
1998 156
1997 139
This necessarily leads to a question I’ve asked before. Are the large number of DDMAC Warning letters issued in the 1990s reflective of the fact that industry just wasn’t very good at compliance and has now gotten much better?
This sort of track record should be explained because it is precisely the point raised by detractors of user fees – that the larger the portion of the enforcement budget comes from industry, the less aggressive is FDA about enforcement. I support PDUFA IV, but there needs to be an explanation for this and it should be made clear before PDUFA IV is enacted.
I would encourage interested readers to review the GAO’s November 2006 report on FDA’s oversight of DTCA. One of the conclusions in that report, and also their report issued in 2002 is that perhaps the reduced number of warning letters can be attributed to the Bush Administration’s policy that all FDA warning letters be reviewed by the Office of General Counsel, which GAO showed has drastically increased the time it takes to issue warning letters from 2 weeks, prior to the new policy, to 4 months, after implementation of the new policy. Here is a link to the report.
http://www.gao.gov/new.items/d0754.pdf