The New Jersey Supreme Court challenged direct-to-consumer advertisers when it ruled that pharmaceutical companies can be held liable if they fail to give consumers sufficient information about the risks inherent in the use of a product.

"The direct marketing of drugs to consumers generates a corresponding duty requiring manufacturers to warn of defects in the product," the court said in the case involving Wyeth-Ayerst's contraceptive Norplant. "Prescription drug manufacturers that market their products directly to consumers should be subject to claims by consumers if their advertising fails to provide an adequate warning of the product's dangerous propensities."

In the past, courts held physicians responsible for ensuring that consumers had adequate information regarding a medicine's risks and benefits. The court, however, ruled that precedent does not apply to medications advertised directly to consumers. The court emphasized that consumers are active participants in their health care decisions—invalidating the concept that the doctor decides whether a product should be used.

Responsibility Shift
Regardless of whether the court's ruling stands, the opinion sends two strong messages to the industry:

1. Pharmaceutical companies with DTC campaigns should not continue to rely on physicians to inform consumers about a product's risks and benefits.
2. Expectations are increasing for companies to provide consumers with information they can use to make informed decisions based on DTC ads.

In other words, companies can no longer have it both ways. By virtue of medications' unique product risks, companies have a greater obligation to inform consumers of risks prior to purchase than do other manufacturers. If a cereal company promotes a granola that tastes like sawdust, the only real danger is that the consumer paid for an inferior product. The equation is far different for a prescription drug that may limit a user's ability to drive a car, perform adequately on the job, avoid serious physical injury, or perform other routine tasks.

Consumers have seen the high-quality information some companies provide with DTC products and have become more aware of what knowledge they need to make informed decisions. When people's health is at stake, they will do all they can to protect it. Consumers will keep that issue alive, regardless of the outcome of the case.

Companies that fail to provide appropriate information in language that consumers can understand will meet increasing public resistance. They must stop ignoring consumers' information needs associated with DTC ads.

PPIs vs. Brief Summaries
Not everyone reads the playing field that way. In contrast to the New Jersey Supreme Court's message, the August 16 issue of Advertising Age called for FDA to release pharmaceutical companies from the obligation of publishing brief summaries with DTC ads.

From an advertiser's standpoint, the editorial may make sense. After all, brief summaries contain highly technical language that the average consumer frequently finds indecipherable. Not only do brief summaries fail to provide any worthwhile information to consumers, but they also waste a good part of a company's ad budget. So, said Ad Age, let's just get rid of them.

In a September 13 response to Ad Age, I noted that companies can use an effective alternative to brief summaries—an option that can benefit both consumers and advertisers. A growing number of pharmaceutical companies are voluntarily developing patient package inserts (PPIs) for some products. Like Brief Summaries, PPIs discuss the risks and benefits of the product to the consumer. But unlike the brief summaries, PPIs present the information in precise, understandable language targeted specifically to consumers. Some companies have even incorporated simplified medical illustrations to show consumers how the medicine works.

As with other DTC materials, FDA reviews and approves PPIs. After approval, they may appear on the back of a DTC ad in lieu of the brief summary. Equally important, they can serve as the basis for all patient information subsequently developed for the product, thereby ensuring a unified, consistent message that can promote drug compliance as well as brand loyalty.

Consumer expectations of pharmaceutical companies are growing as a result of DTC campaigns. Consumers want more information. Companies that recognize their unique responsibility to inform patients—and take firm steps to do so through such means as consumer-friendly PPIs—will reap the rewards rather than the fallout of DTC advertising.

Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.

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Published in Pharmaceutical Executive, October 1999. Copyrighted material; All rights reserved.