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FDA DTC Payola Out, You Pay In!Posted: January 10, 2008Recent changes to how FDA will be paid to review DTC TV ads forces us to ask: What's worse? Drug companies paying the FDA to preview TV ads for approval or you paying for it? Instead of the FDA charging drug companies to review their ads, it will now get the money from US citizens. That's because the DTC User Fee Program authorized by the FDA Amendments Act in September, 2007 was replaced by the fiscal year 2008 omnibus appropriations legislation signed into law Dec. 26 by President Bush (read more about this here). This allocates $6.5 million for the review program for 2008. Unlike the User Fee Program, which would have guaranteed funding for the program for 5 years, there is now no guarantee that funds will be available in 2009 or thereafter. I have one question: Does the drug industry still have its Get-Out-Jail-Free card? ie, if FDA pre-approves an ad, is it prohibited from fining a company if, after the ad airs, the FDA determines the ad is violative? For more on this, read today's post to Pharma Marketing Blog. For more posts in related topic areas, see: If you wish to receive notice by email whenever a post is made to Pharma Marketing Blog, please subscribe.
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Special Supplement Direct-to-Consumer Advertising Volume Two: DTC in the New Era 
DTC advertising is set for major changes in light of public criticism, but also in reaction to the changing reality of the marketplace where there is less need for a one size fits all solution. DTC must evolve and marketers must pay more attention to measuring and improving its effectiveness. Otherwise, billions of dollars will continue to be wasted. This volume is devoted to DTC best practices with a focus on techniques for improving DTC efficacy and return on investment, which is generally considered to be declining.
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