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DRUG AD PHOTOGRAPHS ARE CONSIDERED PRODUCT LABELING, FDA

Executive Summary

DRUG AD PHOTOGRAPHS ARE CONSIDERED PRODUCT LABELING, FDA indicated in a letter to Lilly concerning the company's advertisements for Ceclor (cefaclor). FDA told Lilly that two ads in the January and February 1986 issues of American Family Physician depicting older people smoking cigarettes "are highly suggestive that the drug product is indicated for respiratory problems associated with smoking." FDA Drug Advertising & Labeling Div. Assistant to the Director Arthur Yellin stated that "such a suggestion is outside of the approved labeling for the product in that we are unaware of any adequate scientific evidence directly linking smoking with infections specifically amenable to Ceclor therapy, or use of Ceclor in older smokers as a group." Yellin added that "while we do know that smokers are more susceptible to a wide variety of respiratory problems, this is inadequate to support such claims." Second, Yellin said "reminder" advertisements such as that for Ceclor "may not carry any representations or suggestions of product use." In response to FDA's letter, Lilly replaced the ads in May with a new ad including a brief summary to assure compliance with the agency's "reminder ad" regulations. A statement was also added next to the photograph: "The most significant cause of chronic bronchitis is cigarette smoking." Lilly asserted that the ad "accurately reflects current medical opinion that the most significant cause of chronic bronchitis is cigarette smoking." FDA, in turn, told the firm that "careful reading of the approved labeling for Ceclor limits its use to certain infections including those of the respiratory tract. The labeling is devoid of reference to chronic bronchitis or smoking. Therefore, we find it misleading and potentially false to suggest that Ceclor is useful in the treatment of chronic bronchitis or smokers as a patient population subset. Ceclor neither treats chronic bronchitis nor the effects of smoking." Lilly's response cited reports in the medical literature, including a report from the Surgeon General, that stated cigarette smoking is the "most important" cause of chronic bronchitis. Lilly said its journal ad "was not intended to promote Ceclor for the treatment of chronic bronchitis, but rather for superimposed bacterial infections." The firm proposed changing the statement next to the ad to: "Epidemiologic data show that the more a person smokes, the more likely that person is to develop chronic bronchitis, and patients with chronic bronchitis are at high risk for bacterial respiratory infections." FDA considered the addition of this statement with the prescribing information to settle the issue. The agency also objected to a Ceclor ad containing the statement: "Satisfactory clinical response suggests bacteriologic cure in cefaclor-treated patients with skin and skin-structure infections." Yellin said there is lack of supporting data for this statement since Lilly's ad also notes "posttherapy samples were unobtainable in most patients." He stated that "it is impossible to suggest, with any certainty, a relationship between the clinical cure observed and bacterial eradication." Yellin further objected to the inclusion of six numbered footnotes and six additional explanations. "We would hope that future promotional materials can be designed to include most of this information in the body where it is more likely to be read," Yellin stated. Although posttherapy samples were not obtained in most patients, Lilly maintained that "the fact that there was a satisfactory clinical response in most patients strongly suggests a bacteriological cure." The company said the term "suggests" is not conclusive, but that it would modify the copy if it was reprinted.
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