PDUFA Dollars Up, Warning Letters Down

by Mark S. Senak
Eye On FDA



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.

(Warning Letters by Year)


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.


Source: EyeOnFDA.com



RELATED READING:
- FDA Warning Letters on the Decline

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