If a Tree Falls in the Forest….

J0407218If a tree falls in the forest, and almost no one notices, did the tree almost not fall? 

Pharmaceutical Executive noticed, but I didn’t notice anyone else notice. 

I’m talking about the long-proposed user fee program for the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).  Last week, the program died according to a statement quietly issued by DDMAC in the Federal Register:

"The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not “provided in advance in
appropriations Acts” as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn."

The user fee program was designed to raise money for FDA review of direct-to-consumer ads and by charging companies substantial fees to review ads and then those ads would not be subject to Warning Letters.  They would have the DDMAC stamp of approval, so to speak.  Presumably, if you did not pay to play here, and you were found in violation of regulatory standards, you would not only get a warning letter, but you would also be fined.  This was a Congressional attempt to put a new standard on DTC ads and to put some bite into the regulatory process.

But I’ve written before about the fact that PDUFA dollars keep going up while DDMAC enforcement has declined.  In 1998 there were 158 warning letters issued – by the third quarter of last year, there were only 15.  That’s quite a drop, and not an uncommon enforcement track record across government agencies under this Administration.

I always thought this a bad idea.  Apparently so did everyone else.  The FDA was, according to Pharmaceutical Executive, unable to raise the requisite amount of money from industry by January 25 (tomorrow) which was required to carry out the program.  The legislation was signed into law in September, giving the agency remarkably little time to do so and almost no time for industry to plan advertising and budgets for 2008 that included the user fees.  In other words, this was set up for failure.  Noticeably, FDA did not issue a press release saying that the plug was being pulled on the program, just the quiet little notice in the Federal Register.  If the program never existed and is now never going to exist, is it news when it implodes?

It will be to members of Congress.  At least in part, the PDUFA renewal contained reforms such as this that were an expression on the part of Congress that DTC needs to be better regulated.  Yet, according to Pharmaceutical Executive, Congress also did not provide any funding for the program.  Now that the program (and the intended reform) is apparently not going to happen, the appetite for some kind of reform may not be satisfied.  And we are in an election cycle, where some of the candidates have repeatedly used DTC as one of the many sticks with which to beat the industry.  This is an issue that, unlike the program, is not likely to go away.   

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2 Responses to If a Tree Falls in the Forest….

  1. Sally Robinson says:

    I’m not sure that your posting captures the outrageousness of what happened. I think what actually happened was orchestrated by democratic members of Congress but has managed to fly somewhat under the radar. I found 2 articles on this besides the federal register notice. The Pink Sheet published an article on this issue on January 7, 2008, and FDA Week had an article on this on January 11th. It was my understanding from the articles that the Congress revoked the DTC userfee program due to concerns that drug companies would be paying off FDA to approve their ads. Congress did agree to provide appropriations for this program, but only for 2008. So if funding is not renewed for this program each year, and if funding is not increased annually then staff will have to be let go.

  2. John Mack says:

    Mark,
    You need to get out of the forest to see the trees! I blogged about this back on 17-JAN about a week before the PharmExec story. See “FDA Won’t be Previewing TV DTC Ads!” at http://pharmamkting.blogspot.com/2008/01/fda-wont-be-previewing-tv-dtc-ads.html