FDA data reveals few violations in DTC ads - Only 4 warnings since 1997, Congress told.

Dear Reader,

Over the past four years that FDA has allowed prescription drug direct-to-consumer (DTC) broadcast advertising that mentions claims, the agency's Center for Drugs has issued 85 notice of violation (untitled) letters and four warning letters, and for all advertising print and broadcast to consumers, an agency official told a House Commerce subcommittee June 18.

CDER Director Janet Woodcock, M.D., told the panel: "FDA is not aware of any evidence that the risks of DTC promotion outweigh its benefits."

Woodcock's statement may be a sign that FDA's forthcoming update to DTC ad guidance once promised for late this summer or fall might not clamp down as hard on this breed of advertising as some critics had hoped.

Since August 1997 when FDA issued draft guidance giving the green light to DTC on-air ads, Woodcock said 26 of the 85 untitled letters concerned broadcast ads for 65 drugs, including for allergy products, eight for skin or hair-related problems, 10 to treat diseases believed to be under-treated and five for products to treat or prevent osteoporosis or menopausal symptoms. Each FDA letter asked drug makers to stop violative promotion immediately.

Another 13 cited "reminder" broadcast ads, short commercials usually without claims and lumped with others under one sponsor. Three others concerned "help-seeking" ads that normally are not considered drug ads, "if done properly."

The drug commercials drew four warning letters during the period, she said, but did not describe the violations involved. Generally, she said, "most of the violations cited were because the ad overstated or guaranteed the product's efficacy, expanded the indication or the patient population approved for treatment, or minimized the risks of the product, through either inadequate presentation or omission of information."

Print ads have been around longer because it is easier to insert the side-effects warning and other label information required by FDA to be included in ads that make claims for the drug. Since January, 1997, Woodcock said, the agency has issued 43 untitled letters for print ads or other promotional materials, including reminder and help-seeking materials. She said the one warning letter issued for a print ad resulted from its inclusion "as part of an overall misleading campaign."

Woodcock noted that violations cited for print ads were similar to those for commercials, she said, with nearly all of the reminder ads resulting from "representations about the product that triggered the need for full disclosure of benefits and risks." The help-seeking ad violations were due to "a particular product being implied in the message," she said.

Surveys sponsored by various groups indicated to FDA, Woodcock added, that consumers and physicians generally are comfortable with DTC promotions, but noted other research being planned on the effects of such promotions, with results being reported after the agency has issued its update.

Representatives of drug manufacturers who testified limited their comments to the non-DTC issues, but Gregory Glover, M.D., an attorney speaking for the Pharmaceutical Research and Manufacturers of America, said the industry was pleased with the current ad process and denied assertions by consumer groups that the flurry of commercials has contributed to the rise in drug prices. The amount spent on advertising "has remained fairly constant and the price increases have been relatively modest," he said.

Sincerely,

The Editors