Latest FDA guidance may require copy testing

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What the FDA euphemistically calls “guidances” are usually received by industry with something less than cheers. Despite the name, the guidances are often perceived as directives to be ignored at your peril.

The most recent example, issued in late May, is as usual a draft asking for comments, but based on past experience, the final version is not apt to be far different. And no wonder. Given the fact that past guidances almost invariably imposed new restrictions, spelling out what not to do, most of the comments received from industry raised objections that the agency tended to ignore. Not this latest document: it seeks, instead, to clarify previous agency statements.

As industry observers were not slow to point out that raises a different set of problems.

Here, for example, is a pertinent comment from Dan McKillen, CEO of HealthDay. What's intriguing is that it was forwarded to me by John Kamp, an attorney who heads the Coalition for Healthcare Communication – and neither he nor the coalition is known as part of FDA's fan club. So here is what Dan, who thinks that it's a “pretty good document,” had to say.

“Executives in the Rx advertising industry have been complaining for a long time that they try to make ads that are fairly balanced...[and] don't understand how FDA arrives at some of the conclusions they do when a violation letter is sent saying the advertisements are not in compliance with the regulations.” Now, in this new document, Dan goes on, FDA has provided a lot more detail of exactly what they are looking for in terms of fair balance, along with specific examples of how they review these materials.

In other words, these are not new regs, but an attempt to explain what's acceptable and what isn't.
And in Dan's opinion, the document does a very good job of this explanation. “If industry follows these guidelines,” Dan predicts, “there will be fewer violation letters, fewer ads and commercials that need to be pulled. And probably fewer Vioxx-type lawsuits from people claiming they weren't adequately informed about side effects, risks, and warnings of Rx drugs.”

But as Jack Thorne, chairman of Thorne & Associates, points out, there is also a downside to the guidance. The critical measurement will be the “net impression,” putting the emphasis on how the message is perceived. Does that mean, Kamp and others ask, that advertisers will have to run more focus groups and do other types of copy testing? Kamp thinks the answer is yes: “All this presents a tremendous challenge for advertisers, and copy testing will probably have to be resorted to [to demonstrate that these] communication requirements are met.” What's more, the makeup of these panels will have to be carefully calibrated, as the guidance seems to presume a highly sophisticated audience. But if the panels reflect this bias, industry critics may well demur that the research has been deliberately skewed.

Welcome to the world of FTC.

The Federal Trade Commission has traditionally put its emphasis on how advertising messages are perceived. But what has made living with FTC regulations bearable is that it is rare for FTC (except in cases of egregious wrongdoing) to take enforcement actions. Or perhaps it's wrong to judge by what happened during the Bush years. It remains to be seen what stance an Obama FTC will take.

So what are we to make of all this?

It would seem that in place of previous FDA standards – most significantly the emphasis on fair balance -- we are now going to have to read the tea leaves to determine how recipients interpret the message.  Not that there isn't a good measure of subjectivity in applying the fair balance standard, too, as a number of advertisers have found out. When, after conscientiously trying to balance warning information with claims for effectiveness, they received a letter from FDA, charging that they had (whether deliberately or not) skewed the emphasis in their favor.

Medical advertising has never been easy and it isn't getting any easier. Is that a fairly balanced opinion?
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