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It all started back in October/November 2005 at an FDA public hearing on DTC advertising (see here). That's when AstraZeneca stunned attendees-at least those "in the know"-with written testimony proposing "a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer (DTC) advertising to the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing and Communication (DDMAC) for review prior to its use."

The industry was successful in getting this mandatory review included in the Prescription Drug User Fee Act [PDUFA, sounds like "P'doofah"], which called for drastically raising user fees charged to drug companies from $87.4 million to $392.8 million annually in order to fund an expanded drug safety program, increased screening of DTC ads and the agency's Critical Path initiative.

Somewhere along the way, PDUFA became FDAAA (FDA Amendments Act) and the program to preview DTC ads went up in smoke as in PDUffft!

There was a lot of criticism of FDA collecting fees from the industry to preview DTC ads and many critics pointed out the obvious conflict of interest inherent in such an arrangement.

Consequently, either Congress got cold feet or pulled a trick that was always up its sleeve and refused to provide the "necessary" funding for the DTC preview program in the fiscal year 2008 omnibus appropriations legislation signed into law December 26, 2007, by President Bush. As a consequence, the FDA decided to cancel the program.

It's interesting that the FDA would cancel the program even though the appropriations legislation DID provide $6.5 million of public funds-in lieu of user fees-to run the program through August 2008. The FDA used a somewhat convulted argument based on paragraphs in FDAAA, but its main gripe seems to be that without a guarantee of continued funding for 5 years-as was originally called for in the user fee program-it could not hire the necessary people to preview ads.

I guess hirinig consultants-as FDAt usually does in other cases (eg, physician advisory committees)-was out of the question, although I would have thought that for the $41,390/ad fee FDA was going to charge the industry, that it could hire some pretty knowledgeable temp people.

But using the $6.5 million appropriations rather than user fees would not have allowed the industry to play the "get out of jail free card" that FDAAA included; namely, the guarantee that once the FDA "approved" an ad through the preview process, FDA could not request that the ad be discontinued if it later considered the ad violative (see "DTC Here to Stay; Pet Turtles Too!"). That was the real pot of gold at the end of the PUFA rainbow.

IMHO,

John Mack, Publisher and Editor
johnmack@virsci.com.com