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Chill Out, FTC Advises on Drug Disclaimers

12/07/2003 07:00:00 PM Eastern

Ever see one of those prescription-drug commercials in which the announcer rapidly rips off a list of horrible side effects? Or one where you weren't sure what the pill was for? The Federal Trade Commission apparently has, too, and last week suggested relaxing rules about what prescription-drug makers can and can't say in commercials.

Consumer-targeted prescription-drug ads have been controversial since the Food and Drug Administration approved them in 1997. They are an emerging growth category for television, though, bringing in roughly $1.5 billion a year.

In comments to the FDA, the FTC argued that loosening the rules would make it "easier for consumers to understand" and would be acceptable as long as the ads contain "truthful, non-misleading information." Among FTC's suggested changes, ads would not be forced to contain a "mechanistic balance" between risks and benefits but instead would be required simply to present risks and benefits in a way that does not "convey a deceptive impression of the risk and benefits."

The FTC also said drug makers should be allowed to make "truthful, non-misleading price comparisons and other types of relative cost claims." Endorsements and testimonials should be permitted as long as they meet FTC guidelines for over-the-counter drugs and other products.

The FTC said, risk warnings contained in broadcast ads should direct consumers to a "more useful source of risk information" than the labeling the FDA required as a condition for approving the drug. For instance, information specifically designed for consumers might be more appropriate.

The commission also said available evidence debunks notions that advertising directly to consumers has increased the sale of inappropriate drugs or raised drug prices.

The FTC's comments were submitted as part of drug regulators' plan to revise guidance to advertisers on information that should be in the "brief summary" of side effects and effectiveness that must accompany all ads. The FDA will issue new guidelines next month.

Current regulations require print ads to include all the risk information contained in a product's approved labeling. The brief summary for broadcaster ads is generally shorter because of time limitations. n

 

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