FDA hearing might influence DTC strategy

The Food and Drug Administration last month held public hearings on the future of direct-to-consumer (DTC) advertising.

The Food and Drug Administration last month held public hearings on the future of direct-to-consumer (DTC) advertising.

Although these comment periods are held routinely, the current political climate could spur the regulatory body to legislate certain reforms - perhaps making mandatory some or all of the guidelines drafted this summer by PhRMA.

Current product promotion typically takes one of two forms: the typical DTC campaign and unbranded disease awareness.

If the PhRMA principles are any indication, the spirit behind the FDA's potential DTC reforms will move toward requiring more balanced risk-benefit information, as well as emphasizing physician and patient education. The latter, in particular, seems to call for more unbranded promotion. But many marketing executives have questioned the ROI of trying to sell a product without mentioning what the product is.

Yet product promotion and disease awareness need not be mutually exclusive.

There are a number of very good DTC advertisements that explain how products work and effectively deliver both an educational and a sales message. Many spots for clinical depression expertly take this route, illustrating how a chemical imbalance in the brain triggers symptoms, and outlining what those symptoms might be.

Merck and Schering-Plough similarly understood that an educational message would be the best one to differentiate Vytorin because of the unique way the drug controls the "two sources" of cholesterol.

Drug promotion by its very nature should always demonstrate a level of self-awareness about the seriousness of what is being sold.

The same is true for grassroots disease awareness events. There's a mistaken notion that an educational event must necessarily be unbranded, an idea that misses the point of these efforts.

But it's impossible to truly educate patients on the risks and benefits of a product without explicitly stating what the product is. Companies typically "sell" a product and leave it to doctors to explain how it works - but there's a place for them to be involved in the educational process too.

It's almost as if companies shy away from putting their names on anything that might actually redeem their reputation. No wonder the drug industry complains that the public seems not to notice all of the good things that it does. It's because the industry does them well under the radar.

People remember good DTC promotion, said PhRMA Deputy VP Mark Grayson, who added that while people might criticize DTC outreach as a category, they can usually recall marketing efforts that taught them something or helped them make a medical decision.

Now is the time for companies to own responsible DTC advertising as something that defines their corporate brand and serves a common good.

Two companies already stand out: Johnson & Johnson, which has managed to marry educational and promotional messages, and AstraZeneca, which was the only company to back mandatory adoption of the PhRMA guidelines.

The FDA could take on greater oversight of DTC promotion. It could put in place mandatory restrictions on the types of advertisements that companies run or draft a standard formula for communicating risk-benefit information.

These would be appropriate steps. But unless the industry changes philosophically, it will continue to be criticized for the way it markets products.

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