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TAKEDA-ABBOTT LUPRON PROMOTIONS WILL HAVE TO BE PRECLEARED BY FDA UNDER LETTER OF ADVERSE FINDING; AGENCY CHIDES FIRM FOR PROMOTING UNAPPROVED USES

Executive Summary

Takeda-Abbott Products' promotions for Lupron Depot will have to be precleared by FDA if the agency has its way, according to a letter of adverse finding sent to Takeda-Abbott Products (TAP) on March 21. In the letter, FDA said it has "recently received through industry complaints information indicating" that Takeda-Abbott "has undertaken a deliberate campaign to promote this product for a wide range of unapproved uses." FDA's letter focuses on detailing visits by Takeda-Abbott sales people to OB/GYN physicians to promote Lupron Depot for endometriosis fibroids. FDA met with Takeda-Abbott representatives in late 1988 to discuss similar promotions of unapproved uses for Lupron. "Lupron's sole approved use, palliative treatment of advanced prostatic cancer, is not within the usual range of activities undertaken by OB/GYN specialists," FDA noted. "However, the unapproved uses of Lupron previously promoted by your firm would be within the usual practice of OB/GYN specialists. These physician visits strongly suggest promotion of unapproved uses." FDA also censured the firm for a patient information brochure on Lupron that discusses unapproved uses of the drug. The brochure, prepared by the Reproductive Education and Choices for Health (REACH) on behalf of TAP, was also the subject of an earlier meeting with FDA. At that meeting, TAP "acknowledged" that its efforts to ensure the quality of the materials produced by REACH "did not succeed," according to the FDA letter. The REACH brochures, FDA said, "actively promote [Lupron] administration in a range of indications for which [the drug] is not approved and apparently has not been adequately demonstrated to be safe and effective." The brochures, FDA said, "focus upon administration of Lupron for these unapproved uses to an excessive degree rather than uniformly covering the array of available treatment options for these medical conditions." In addition, FDA said it is "strongly opposed to any involvement of a firm in creation, dissemination or funding of promotional/scientific/educational activities directed to consumers when those activities involve discussion of unapproved uses." FDA also expressed its concern regarding the "direct dissemination of the brochures by patient groups as well as by physicians who had elected to administer the drug for these unapproved uses." FDA noted that Takeda-Abbott did not inform the agency at their December meeting about the direct promotion of the drug for endometriosis. FDA asked the company to preclear all promotional activities for Lupron "until further notice" and suspend all public activities that "promote or discuss administration of Lupron or GnRH agonists for unapproved uses." The agency also asked the company to submit a written agreement to FDA regarding future promotional activities for Lupron and to provide a written description of the company's involvement in the promotion of unapproved uses for the product. Although Lupron was the first GnRH antagonist to reach the market following FDA approval in 1985, the product is now facing two serious competitive challenges. ICI's Zoladex was approved in December of last year and was launched in January for use in advanced prostate cancer. In addition, Syntex received approval in February for intranasal Synarel for the treatment of endometriosis. TAP has supplemental NDAs pending for Lupron use in treating endometriosis and uterine fibroid tissues; the latter indication, however, was rejected by an FDA advisory committee last fall ("The Pink Sheet" Oct. 30, p. 18). Although the Lupron letter from FDA's ad division was directed to Abbott's U.S. joint venture with Takeda, TAP, Abbott's promotional efforts for the antihypertensive Hytrin was also recently the subject of a letter of adverse finding from the agency ("The Pink Sheet" Jan. 29, T&G-5). That case also involved a brochure that, according to FDA, promoted unapproved uses. Abbott has agreed to revise the claims ("The Pink Sheet" March 12, T&G-8).
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