New DTC Oversight Powers Given FDA – Show Me the Money!

I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. 

J0385339A new user fee program for review of DTC ads will exist that allows the FDA to charge manufacturers to review proposed DTC advertising in exchange for a "good-FDA seal of approval" that will serve as a get out of jail free card respecting violations that would otherwise merit a Warning Letter.

There are many intriguing aspects to this system.  But the question that bothers me most is the fact that DDMAC enforcement over DTC has been anything  but robust under the Bush Administration.  The rate of warning letters and untitled letters issued to companies has deteriorated dramatically, as I’ve pointed out before.  Unless FDA intends to again begin picking up on enforcement, what is the point for a manufacturer to pay a hefty fee for FDA to review the advertising campaigns?  Or does it become a necessary tax at this point – pay up for review, or we will begin issuing warning letters again? 

While you don’t have to participate, the question is will companies that don’t pony up the money suddenly become subject to increased scrutiny by DDMAC or will it be the same standard of enforcement that has been seen over the past several years?

And, under this system, you can get more than a Warning Letter, you can get slapped with a hefty fine.  So either way, you end up paying.

There are other interesting aspects of the system pointed out by the RPM analysis.  For example, the article speaks at length of the fact that companies will have to pre-determine how many ads campaigns they need reviewed at the beginning of the year and then pay up.  If they go with less, they get no refund.  If they go with more, they have to pay a penalty fee. 

Either this new system will result in higher quality DTC advertising from a regulatory perspective, or a cash cow for the FDA. 

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