Rx ads reach couch potatoes

The FDA loosened restrictions for advertising prescription pharmaceuticals on television and radio.

As of August, any TV or radio advertisement that mentions both the name and purpose of a prescription drug must include a "major statement" of a product's most important risk information and an "adequate provision" for the dissemination of more detailed labeling information.

This provision is meant to replace the traditional "brief summary" often found in other advertising vehicles, such as magazines and newspapers. It should eliminate two-minute-long advertisements that are nearly 50% text, such as the one Pharmacia & Upjohn created and premiered for its contraceptive Depo-Provera in July. (Most television and radio commercials are less than one minute in length.) It should also discourage companies from producing vague, and often confusing, advertisements that mention a drug's name without giving any indication of its use.

"The 'adequate provision' requirement recognizes the inability of broadcast advertisements of reasonable length to present and communicate effectively the extensive information that would be included in a brief summary," the FDA stated in a Federal Register notice. "It instead specifies that presentation of the advertised product's most important risk information as part of the 'major statement,' together with 'adequate provision' for the dissemination of the approved labeling, can fulfill the risk information disclosure mandated by the act."

According to the new guidelines, ads can refer consumers to an Internet address, a toll-free phone number or other sources where complete information on the product can be found, such as in libraries, pharmacies or physician offices. Companies must accommodate the limitations of consumers who may not have access to sophisticated media, such as the Internet, to research complete product information. Companies are not permitted to over-emphasize the effectiveness of a product or minimize a product's potential risks.

The Pharmaceutical Research and Manufacturers Association, Washington, supported the FDA's decision.

"Direct-to-consumer advertising enhances consumer knowledge about diseases and treatments," read PhRMA's official response. It also stated that direct-to-consumer advertisements may foster competition among products, lead to improved quality and lower prices for consumers, and encourage dialogue between patients and doctors.

First in line

Several pharmaceutical companies immediately rushed to air television commercials that had been prepared in expectation of the FDA's announcement. Schering-Plough, Glaxo Wellcome and Hoescht Marion Roussel were among the first to test the waters, with mixed results.

Schering-Plough's 30-second ads for the antihistamine Claritin did not meet the modernized guidelines, the FDA decided immediately. The agency reprimanded the company, and within a week the ads were stopped. Revised versions were cleared by the FDA for broadcast a week later.

Glaxo Wellcome's 60-second ad for the antiherpes medicine Valtrex and Hoescht Marion Roussel's 60-second ad for the antihistamine Allegra did not receive any objections from the FDA.

Commercials from other pharmaceutical companies are likely to follow fast on the heels of the first few, leaving many to predict a windfall in advertising dollars for top ad agencies. New York-based Grey Healthcare Group forecast a "dramatic increase in spending," mostly on television advertisements.

Grey also suggested that advertisements for prescription medicines will assume the same traits and tone as over-the-counter advertisements. Pharmaceutical brands will assume more importance in consumers' minds. Emotion and consumer insight may also be strong selling factors in commercials.

Products not advertised on television or radio will not necessarily suffer in sales, according to Grey: "A unique drug will still be able to be sold with branded indication advertising. But the minute there is competition, branding will be necessary."

Stay tuned

The FDA will not establish a committee to formally monitor the effects of looser regulations. Instead, the agency urged industry members to take the lead in analyzing how direct-to-consumer advertising affects public health; to what extent consumers use the resources provided by broadcast media to obtain more complete labeling information; and how risk messages can be best integrated into broadcast advertisements. PR