As I see it

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Now come the ad police to ask for user fees from marketers. Admittedly, it's just for TV ad previews, but the FDA's Prescription Drug User Fee Act 4 reauthorization proposal may be seen as the thin end of the wedge — and the dawn of a new era.

Reflecting an informal agreement with affected advertisers, the FDA's proposal seeks $6.2 million in voluntary user fees to pay for 27 new staff in the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to review TV ads and related projects.

Perhaps to help grease the skids, commissioner Andrew von Eschenbach told Reuters that the DDMAC's role should be more to “help” companies produce acceptable ads than to enforce after bad ads have aired.

This bespeaks a whole new era of friendliness between the DDMAC and industry, as has occurred in other parts of the FDA that have been receiving the fruits of product-approval user fees since 1994. A cozy buyer-seller culture develops between the participants, with the regulators eager to please customers.

Putting aside for the moment the issue of whether the DDMAC should behave as a polite but firm cop on the beat, or as a paid consultant, its enforcement output has been dwindling, as if in anticipation of the new era.

The DDMAC last year issued only one-sixth as many warning letters in 2006 (22 in all) as it did in the waning years of the Clinton administration (156 in 1998, 108 in 1999). If you ask, you might be given the doubtful proposition that this trend simply reflects a steady, positive improvement in industry compliance with the regulations.

However, I think we're seeing the consequences of years of DDMAC resource-starvation, now reaching a point where user fees from industry are seen as the only solution. First TV ads, then print, then everything.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)

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