Does Yaz correction signal a DTC shift?

It's one of the strangest drug ads you'll probably ever see: An attractive young woman explaining why Bayer's birth control pill Yaz isn't all it's cracked up to be. Don't take Yaz thinking you'll get clearer skin or find yourself in a better mood come PMS time, the ads note. Never mind what our ads might have said before.

The commercials are part of Bayer's settlement with FDA and attorneys general in 27 states. You'll recall that the drugmaker agreed to spend $20 million on corrective ads to placate regulators angry about previous advertising they considered misleading. In addition to the DTC backpedaling, the company also has to submit all future Yaz ads for federal OK before they're aired, for the next six years.

It's quite a departure from the FDA's usual slap-on-the-hand warning letter. "They rarely require these corrective campaigns," one patient advocacy expert told the New York Times.

Does this settlement herald a new vigilance about DTC advertising? Let's be realistic: The FDA still has a paltry staff and budget in its drug promotion division. In the Yaz case, the agency was responding to complaints from women's groups and, more importantly, the state attorneys general. What the deal may do is raise more questions about FDA oversight of advertising. But considering the laundry list of reforms on tap for the agency, those questions will just be a few of many.

- check out the original Yaz "Balloons" commercial
- read the NYT story

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