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ABBOTT HYTRIN BROCHURE HALT

Executive Summary

ABBOTT HYTRIN BROCHURE HALT requested by FDA in a Notice of Adverse Findings sent to the company on Jan. 17. FDA Drug Advertising and Labeling Division Acting Director Kenneth Feather said in the notice that the agency's "objections" to the Abbott promotional campaign for the antihypertensive terazocin "are based upon [the] firm's promotion of unapproved uses of Hytrin." FDA asked the firm to immediately suspend distribution of a promotional brochure for Hytrin entitled "Matching Mechanism to Mid-Life." In addition, the agency requested that Abbott recall "all supplies of similar promotional materials" from its sales force and destroy the materials. The offending claims in the brochure, according to FDA, include: "no adverse effect on BPH (benign prostatic hyperplasia)"; "increases peak urinary flow rate (53.1%); "decreases residual volume (60%)"; "significant improvement in obstructive symptomatology observed (p<0.001)"; "maintains hemodynamics"; "maintains sexual performance"; and a lipid lowering claim. Regarding Abbott's claim for BPH, FDA noted that that BPH "is a generally recognized disease." Consequently, FDA explained, "symptomatic treatment of this disease clearly constitutes an unapproved use for Hytrin." The agency said it does not object "at this time to claims that a product does not adversely affect a concomitant disease state." However, the letter adds, "it must be considered promotion of an unapproved use for your firm to present leading claims reflecting the absence of a detrimental effect upon a concomitant disease, followed by prominent claims clearly suggesting a beneficial effect upon that concomitant disease." The Abbott brochure makes the claim that Hytrin has "no adverse effect on lipids" and in a 128-patient study caused "significant reduction of total cholesterol and [low density lipoprotein and very low density lipoprotein] cholesterol." FDA reminded Abbott of communications with the agency in March and January 1989, and December 1988 regarding the lipid claim. At that time, FDA told the company that it would have to submit data for a supplemental NDA in order to make any claim on cholesterol for Hytrin. FDA's January 1989 letter noted that "none" of lipid changes in the study cited by Abbott were "clinically significant" and may have been an "artifact caused by hemodilution." FDA also reiterated its position on the use of the word "maintains" in promotional material. According to the agency, the use of the word misleadingly suggests "contributory effects." FDA also reminded Abbott of correspondence with the company in June and July 1988 in which FDA stated its position on the use of the such claims as well as a Notice of Adverse Findings sent to Schering in March 1989 for similar claims. "We now find similar objectionable claims being introduced by your firm more than four months after your stated deadline for discontinuance of such claims," FDA told Abbott in the Jan. 17 notice. "Your firm's willingness to continue to promote this product in violation of the federal FD&C Act suggests that it did not negotiate with our office in good faith."
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PS016843

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