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Executive Summary

ABBOTT HYTRIN PROMOTIONAL CLAIM FOR BPH WILL BE REVISED "to conform more closely" with the approved labeling for the product, the firm told FDA in a recent letter. In addition to the benign prostatic hyperplasia claim, the firm has agreed to revise lipid claims for its antihypertensive Hytrin (terazocin), according to a March 6 FDA memo. FDA's objections to Abbott's promotional tactics were voiced in a Jan. 17 Notice of Adverse Findings, which called on the company to cease distribution of Hytrin promotional brochure ("The Pink Sheet" Jan. 29, T&G-5). The agency found that the brochure implicitly promoted the drug as a treatment for concomitant disease states for which the drug is not approved. Specifically, FDA complained that a statement that Hytrin has "no adverse effect on BPH (benign prostatic hyperplasia)," and suggestions of a beneficial effect on BPH symptoms -- "increases peak urinary flow rate (53.1%)"; "decreases residual volume (60%)"; "significant improvement in obstructive symptomology (p < 0.001)" -- added up to a claim that the drug contributes to treatment of the disease. The agency had the same objection to statements that Hytrin "has no adverse effect on lipids" and in an 128-patient study caused "significant reduction in total cholesterol." While conceding to changes proposed by the agency, Abbott vigorously disagreed with FDA's contention that the disputed claims constituted promotion for unapproved uses. "Abbott does not agree with the Agency's position that mere presentation of clinical data constitutes 'promotion' of a drug for an unapproved use," the company said in a Feb. 7 letter to FDA. Taken in context, the statement on BPH merely "demonstrate that Hytrin does not exacerbate the disease of benign prostatic hyperplasia contrary to other hypertensives, such as thiazide diuretics," Abbott maintained. The company also strongly denied that its lipid information could be interpreted as a cholesterol-lowering promotion. "The promotional piece contains no statement, or even implication, that Hytrin would be effective in the treatment of hypercholesteremia," Abbott asserted. The firm pointed out that the lipid information discussed in the brochure was used to support a paragraph on lipids in the current approved package insert for Hytrin and is also used in the Hytrin Summary Basis for Approval (SBA). The conclusion in the SBA states that terazosin "is associated with small, but favorable directed changes in serum lipids," according to Abbott. Abbott acknowleged, however, that claims that the drug "maintains" sexual performance and hemodynamics contradicted a previous agreement with FDA not to use the term "maintains" without approval. The agency believes the word misleadingly suggests that a product makes contributory effects to a condition. Abbott said use of the word was unintentional and the result of "inadequate proof-reading." FDA's March 6 memo of a conversation with the firm indicates that the agency has accepted Abbott's proposed revisions, "so long as the firm maintains this conservative their other promotional activities." Abbott has told the agency it will prepare new promotional material incorporating the revisions and destroy supplies of the current brochure.

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