Wednesday, May 23, 2012

Shire Seeks to Maintain YouTube "Loophole" in FDA's Draft Guidelines for TV Ads

FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).

Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.
Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. 
"BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." 
BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.
Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:
"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."
Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."

FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."

However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.

As part of that process (e.g., submission of static storyboards for video ads), FDA estimates that "approximately 2 hours on average would be needed per submission, including the time it takes to prepare, assemble, and copy the necessary information." Compared to that, the creation of "final filmed" versions of TV ads is indeed a significant burden on sponsors. However, since FDA's new guidelines are specifically aimed at products with significant safety concerns, it "behooves" the drug industry to carry that "burden" in the interest of patient safety, IMHO.

3 comments:

  1. The FDA has maybe 10 folks to check ALL marketing 2253 submissions. I don't think they have ever stopped any ad until it went live & some competitor complained.

    The companies use the submission to claim to juries that the FDA "approved" the ad. The main purpose of this regulation is as part of a tort defense. FDA should stop acting like it does something it never does. Let the free market and the courts decide.

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    1. David,

      Thanks for your comment. Are DTC TV ads cited as evidence of drug safety in many tort cases?

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  2. sure are. Vioxx Dorothy Hammel ads were a big hit. Lanier the plaintiff lawyer stopped his opening every 15 minutes to play a commercial after saying "listen for the warning." Opps no warning. Company response was we gave them to the FDA and they approved them. tort lawsuits and not FDA regulations are the main barrier to lies misrepresentations and other illegal activities. FDA penalties including multi-billion dollar settlements are a joke.

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