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Executive Summary

HOECHST-ROUSSEL REVISED INTERMITTENT CLAUDICATION INSTITUTIONAL AD for television will "increase public awareness of intermittent claudication and . . . advise the public to see their doctor -- but without implying that a prescription drug from Hoechst" (i.e., Trental is the remedy, FDA noted in a memo of a recent meeting between representatives from the firm and FDA's Rx Drug Advertising & Labeling Division. FDA's meeting with Hoechst followed an Aug. 19 letter to the firm objecting to its television ad on intermittent claudication. FDA had told the firm that the agency disagreed "with your contention that because 'there is no mention of the drug's name in this television advertisement,' it is an institutional ad and, thus need not comply with the advertising section of" the FD&C Act. FDA explained that "because of the emphasis it places on the availability of a drug for treating intermittent claudication, the commercial is, per se, at a minimum, an advertisement for a prescription drug." The memo states that "it was agreed that the proposed revision would be satisfactory if the language . . . were revised from 'And now there's effective treatment your doctor can prescribe' to something that says, essentially, 'And your doctor can prescribe an effective treatment program.' " FDA notified the firm in an Oct. 9 letter that it has "no objection to the revised message, as presented in story board form, for television presentation." The firm plans to air the revised ad in December. Noting that Hoechst intends "also to use the message in consumer print media in 1986," FDA stated that "for print media, since you are not limited to 30 seconds, we recommend that you expand on the meaning of 'effective treatment program,' e.g., smoking cessation, diet, exercise, etc." This recommendation was made for the TV message, FDA noted, "but withdrawn only because of time and space limitations."

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