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Executive Summary

Merrell Dow's mock-up anticholesterol TV spot, which cites "prescription medication" as one possible therapy, approaches the "gray area" between a strictly educational message and a drug advertisement, FDA Drug Advertising & Labeling Division official Louis Morris told a Food & Drug Law Institute seminar in Washington, D.C. Jan. 25. After watching a tape of the ad, presented during a panel session at the meeting, Morris commented: "I think we're more likely to say, 'why don't you leave it here a while and let us think about it?' . . . I think we'd like to show it to a few people at the agency and get a couple of opinions." The Merrell Dow message states: "When cholesterol levels are over 200, that can be trouble . . . Government scientists have determined that the desirable cholesterol level for people over 30 is 200 or less. Most Americans exceed 200 and may face an increased risk of hear attack. Get tested. Diet, lifestyle changes and possibly, a prescription medication can help. See your doctor." "The question is, is this an ad for a prescription drug," Morris said. "The fact that you're mentioning, 'possibly a prescription drug' gets in closer to that gray area. Clearly the fact that the message is broad, mentioning dietary changes, lifestyle changes and possibly prescription medication, will help. But I think we'd want to give it more of a consensus judgment." Merrell Dow currently has no plans to air the segment. Merrell Dow Product Planning Director Kirk Schueler presented the mock-up to the meeting along with Medicus Consumer Communications Exec VP Joseph Davis. The TV spot was one of three versions presented to the panel for discussion. One version did not mention prescription drug therapy, but only advised: "Your doctor has treatment programs that can help." Another stated that "diet, lifestyle changes and possibly a prescription medication can reduce cholesterol levels up to 50%." The panelists agreed that while the first spot was likely to meet little resistance from FDA, the third made a specific claim, which would probably incur FDA regulations for prescription drug advertising. In addition to Morris, the panel included D.C. attorney Peter Safir (Kleinfeld, Kaplan and Becker). FDA's Morris said that the agency has "historically" not interpreted the term 'treatment programs' alone in educational messages to mean necessarily drugs. However, he added, "if we find out people are interpreting [the term] that way, then maybe we must consider that an ad for a prescription drug. So here's a case where our determination historically can change if there's new information in front of us." Commenting on the version with the 50% reduction claim, Safir stated that "just as a strategic matter, I would recommend against this kind of claim." He pointed out that "once you put in that kind of claim, you're . . . not only asking the [FDA] division of drug advertising to consider whether this is an advertisement for a prescription drug, but now you are asking them to go back to the [FDA drug review] division and check the claim." In the drug review division, he pointed out, "you are going to find people even more opposed to the idea of direct-to-consumer advertising than in the drug advertising division."

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