EASIER RULES START FOR TV, RADIO ADS FOR PRESCRIPTION DRUGS

CHAPIN CLARK / Additional reporting: JOEL ELSON

WASHINGTON -- Easing restrictions on drug companies' television and radio product advertising, the Food and Drug Administration has begun a new era in the direct-to-consumer marketing of prescription medicines.

Supermarket pharmacy directors contacted by SN last week anticipated greater clarity in manufacturers' messages to consumers as well as more educated and active customers.

As part of the FDA's new rules, prescription-drug manufacturers will no longer be required to include the so-called "brief summary" of a product's side effects, contraindications and effectiveness -- a thicket of esoterica -- in broadcast advertising.

Instead, manufacturers now must include only a "major statement" listing the major risks associated with the drug, as well as information -- a toll-free telephone number or a web site address, for example -- on how consumers can learn more.

Print ads are unaffected by the new guidelines.

"No question that these ads will educate and make consumers aware of drugs that they didn't know about," said Barrett Moravec, pharmacy director of Abco Foods, Phoenix. "I've got a hunch that we'll get a lot of support from the manufacturers, who are going to be stressing certain products in this environment, and that they will make a lot of consumer literature available at the pharmacy."

Moravec added, however, that he was "not sure there will be an immediate, measurable increase in sales traffic. I think people will first consult their physician after seeing or hearing the ads."

Jody Stewart, director of pharmacy operations at Raley's Supermarkets, West Sacramento, Calif., agreed. "I think it's more the doctor who bears the brunt."

"Somebody coming up cold to inquire about a prescription drug doesn't usually happen," said Pete Gasenberger, pharmacy director at Consumers Markets, Springfield, Mo. "But this may change with these ads."

Under the new provisions, pharmaceutical companies will also be able to run ads that both name a prescription drug and make claims for its efficacy. In the past, drug makers relied on "reminder" ads, which stopped at the simple mention of a product's name and were exempt from the FDA's "brief summary" requirement.

Lenora Waddell, pharmacy coordinator in the Jacksonville, Fla., division of Winn-Dixie Stores, expressed mixed feelings about the changes. She welcomed the prospect of a clearer message from manufacturers but was concerned about the suggestibility of consumers.

"It's got its good points and its bad points," she said. "You can't tell everybody everything they need to know in a 30-second commercial, and a lot of people, when they see these things, they think, 'I've got that [condition]!' "

Stewart added that drug companies will be especially challenged in creating direct-to-consumer ads for certain types of prescription products, like tranquilizers and diet pills, as opposed to allergy medicines, say, or H2 antagonists.

Kansas City, Mo.-based Hoechst Marion Roussel and Glaxo-Wellcome, Research Triangle Park, N.C., have been among the first to take advantage of the new guidelines, with 60-second TV spots for the antihistamine Allegra and genital-herpes treatment Valtrex, respectively.