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ORTHO ADS CLAIMING TERAZOL SUPERIORITY TO MONISTAT LACK SUPPORT IN CLINICAL DATA — FDA REG LETTER; SEVERAL CLAIMS CITED BY AGENCY FOR LACK OF FAIR BALANCE

Executive Summary

Ortho's Terazol comparative ads to Monistat have "no basis for ... superiority" in terms of either safety or efficacy, FDA told the company in a Nov. 16 reg letter. "We have reviewed your firm's clinical monograph for Terazol and the data submitted by your firm in support of your new drug applications," states the letter, signed by Office of Drug Standards Deputy Director James Morrison. "That review indicates there is no basis for claims of superiority for Terazol relative to miconazole nitrate in terms of either safety or efficacy." The reg letter outlines FDA's objections to Ortho's introductory promotional campaign for Terazol vaginal cream and suppositories and admonishes the company for not submitting the ads for FDA preclearance. Approved in December, Terazol 7 cream was launched in June in a joint campaign with the just-approved Terazol 3 suppository dosage form. The Ortho professional ads attempt to position Terazol (terconazole) as an improvement over the company's other antifungal, Monistat (miconazole). The two products, indicated for Candida yeast infections, are comparably priced. However, Terazol carries patent protection to the year 2001; the Monistat patent expires in 1991. In its review of Ortho's Terazol ad claims, FDA objected to several claims, including: - - "The advantages of miconazole nitrate, and then some ...," which FDA contends is an unwarranted superiority claim; - - "Outstanding microbiological cure rates ... statistically significant difference shown (in favor of Terazol)," "Low rates of relapse" and "Total Symptomatic Relief by Day 3," which FDA said reflected a selective presentation by Ortho of the clinical data for Terazol; and - - "Lower incidence of burning and itching," which was cited by FDA for lack of fair balance. FDA maintained that the "itching and burning" claim disregarded Terazol's "higher incidence of other side effects ... relative to miconazole nitrate." Commenting on the safety study results, FDA noted that the "overall incidence of side effects was roughly comparable" for both Terazol and Monistat groups. In addition, FDA objected to the clinical monograph Ortho distributed to physicians. The monograph, FDA asserted, "presents data selectively so that Terazol appears superior in terms of efficacy and safety, although the data indicate otherwise." The agency also requested documentation of Ortho's press activities and said it may request a "remedial press kit" be sent out "to correct erroneous impressions of the safety and efficacy of Terazol resulting from your firm's press-related activities." The FDA letter outlined several recommendations for the J&J subsidiary, including immediate cessation of the current promotional campaign accompanied by a formal statement to FDA regarding that action. A J&J spokesperson said the ads scheduled for January have been pulled. In addition, FDA asked the company to prepare a "Dear Doctor" letter that will be sent "to every physician and pharmacist in the U.S. to correct the false and/or misleading impressions purveyed in this campaign." FDA also suggested that Ortho develop and submit to the agency a remedial advertisement to correct any false or misleading impressions left by the campaign, and publish the advertisement "in two consecutive issues of each publication that carried the advertisements from this campaign." Finally, the agency requests a "revised monograph for Terazol that objectively and comprehensively describes its absolute and relative effects." Another J&J promotional campaign is receiving close scrutiny from FDA. Ad division staffers have indicated in recent speeches that J&J's promotion of Retin-A for use in treating wrinkles - an unapproved use - may receive a response from the agency.
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