Is the End Near for DTC TV Ads? Sanofi Says Yes

Is the End Near for DTC TV Ads? Sanofi Says Yes

May 23rd, 2012 // 12:34 pm @ jmpickett

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Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their TV ads for agency review. The FDA has had the authority to review ads ever since the Food and Drug Administration Amendments Act of 2007 was enacted and the recent draft guidance makes clear that reviews are required for direct-to-consumer ads for a variety of situations.

These include initial TV ads for any prescription drug; an initial TV ad for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy, or REMS; all TV ads for Schedule II controlled substances; the first TV ad following a safety labeling update that affects a boxed warning, contraindications, or warnings and precautions section, and the first TV ad following an enforcement letter (here is the draft guidance).

However, one drugmaker cautions that the expense involved in producing TV ads is so great that any revisions made by the FDA may prohibit DTC TV ads from running. In a May 11 letter to the FDA, Sanofi writes that “additional comments received from the agency after production of a final recording would require reshooting and re-editing, thus would be both costly and resource intensive for the sponsor. The process presented in the guidance would potentially require the sponsor to cease to the use of TV ads as a vehicle to educate consumers due to significant production challenges…”

Instead, Sanofi suggests that the FDA accept storyboards – scene-by-scene depictions of what is to appear in an ad – or an “animatic” version in lieu of recorded footage (here is the Sanofi letter). In this way, of course, a drugmaker and its advertising team could save money and time if the FDA indicates that changes must be made to a finished ad.

This assumes that no tweaks – forget about mistakes – would find their way into an ad after the agency approved a set of storyboards. Of course, drugmakers that violate such a grand bargain would face the wrath of the FDA if a subsequent TV ad somehow differed from the storyboard or animated version that had been submitted for review and given approval. But such a system is not foolproof.

The FDA already reviews storyboards submitted prior to some ads being run, as John Mack notes on PharmaMarketing. And he reminds us that, four years ago, the FDA issued a warning letter (here it is) to Bayer for a TV ad for its Yaz birth control pill, even though storyboards had apparently been reviewed (the FDA offered the storyboard as evidence of a violation).

In other words, if a problem does arise due to any changes, however miniscule or inadvertent, the agency may not notice until much later. By then, the ad is likely to have reached its intended audience. This underscores the agency insistence on reviewing ads prior to airing – there is no substitute, after all, for a final work product. But will drugmakers balk and curtail TV ads?