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FDA's regulation of direct-to-consumer ads is shifting its focus from the content of such ads to the effect that an ad has on consumers, FDA Division of Drug Advertising and Labeling Acting Director Lou Morris, PhD, told a Food & Drug Law Institute conference Sept. 11. "I think what's happening is an evolving standard," Morris said. "We're moving away from just looking at the content of the ad and looking at the effect of the ad itself on how we think it's going to be perceived." The shift in emphasis will be reflected in a forthcoming direct-to-consumer ad guidance. Morris said the difference lies in whether an ad causes a consumer to seek out their physician about a medical condition or to request a specific drug product. "What does the patient, if influenced by the ad, say to the doctor when they respond to the advertisement?" Morris queried. "If they say: 'Doc, I want help with this condition,' then that's a health-seeking ad. If they say on the other hand: 'Doctor, I want this [specific] drug that was advertised, then that's an advertisement for prescription drugs." To help determine how a "typical" consumer sees an ad, the division continues to encourage companies to submit ads for preclearance and has begun recently to ask drug companies to provide market testing results. However, relying on consumer testing, Morris noted, raises a new set of questions. For instance, FDA has to weigh the quality of the test and wrestle with how to interpret test results. "If 50% of the people ask for a drug, is that the issue? If 30%...10%?" Morris asked rhetorically. He noted that the agency expects industry to pay for such consumer tests, but they will not be routinely asked for by FDA. FDA has had to develop this new standard in response to the prevalence of what Morris called "backdoor promotions" to consumers for prescription drugs, such as major public relations campaigns and media appearances. He noted that in the "old days" if an ad mentioned a drug's name or was the only therapy available for a medical condition, then it was defined by FDA as a drug ad. * As more companies are promoting prescription drugs to consumers in various media, FDA's review of ads has become more complicated. After defining an ad, FDA next has to determine whether the prescription drug ad is acceptable as a direct-to-consumer vehicle. Morris outlined a series of tests the agency uses to make that acceptability determination. First, the direct-to-consumer ad must provide the brandname and the generic name. "Interestingly," Morris commented, marketers come to the ad division and "say: 'Yeah, it's an ad for a prescription drug but we didn't want to name the product because we thought [that] would lead to more problems.' You have to name the product if it is an ad for an Rx drug," Morris noted. "It's one of our many Catch-22's." The "second major question" the division looks at is whether an ad is false or misleading. The same criteria apply as for physician-only ads, Morris noted. The third issue is the adequacy of the prescribing provisions. With the increasing prevalence of new technologies to reach consumers, Morris said: "Our view of these contingent on the issue of is the provision for prescribing information adequate?" He noted that with visual media, adequacy is a considerable problem. * The evolving agency standards for direct-to-consumer ads are contained in a policy statement that is being reviewed by the commissioner's office. On the matter of the guidance's publication, Morris said: "I think with terms of football [they operate in extra long] 'football minutes.'" Morris raised the notion that the policy statement in combination with the guidance on company-sponsored symposia may have some unintended negative effects on the tenor of direct-to-consumer ads. He theorized that the agency's policies may lead to health-seeking ads becoming "fear appeal" ads that relay to consumers information on a medical condition that gives them the impression that they better hurry to a doctor to get help. "It's something to watch," Morris noted.



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