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Executive Summary

Schering-Plough's promotion of relaunched Chewable St. Joseph Low Dose Adult Aspirin for prevention of myocardial infarction "represents an unapproved new use," FDA told the company in a July 20 regulatory letter. The St. Joseph 81 mg aspirin product "bears labeling and is intended exclusively for adult use in the prophylaxis of myocardial infarction (MI) and/or other cardiovascular-related indications, as well as adult use as an analgesic and/or antipyretic," FDA declared. Plough pulled St. Joseph children's aspirin from the market in the fourth quarter of 1986 in response to concern over aspirin's association with Reye's Syndrome in children. Plough's relaunch of the children's aspirin line for the adult market seeks to capaitalize on recent interest in the use of lower dose aspirin following the Jan. 28 publication in the New England Journal of Medicine of the Physician's Health Study, which showed that regular aspirin use in healthy patients reduced the risk of heart attack ("The Pink Sheet" Feb. 1, 1988, T&G-1). FDA and the company, through letters and meetings, have been in close communication over the labeling of the low dose aspirin product since April 15. After a June 22 meeting with agency officials, Plough submitted proposed revised labeling to FDA. Current labeling for the low dose aspirin includes statements such as: "Ask your Cardiologist/Doctor . . . If you take aspirin frequently, you may benefit from the flexibility of a low dose form." The labeling also states: "Aspirin is a proven aid in reducing the risk of a second heart attack for people who have already suffered one, or for those who suffer from unstable angina. Low dose aspirin offers a probable lower rate of gastrointestinal side effects." At the June 22 meeting, FDA noted its concern with the use of the statement, "Ask your Cardiologist/Doctor" and with the term "Low Dose." FDA viewed the term "Low Dose" as "suggestive that the intended dose was a low dose (less than 325 mg), which is inconsistent with the standard recommended dosage," a meeting memo says. FDA was also concerned with the use of promotional material to the trade that suggested use at a lower dose than the FDA-approved dose. Plough responded to the agency's concerns in a July 1 letter. "We are deleting the term 'cardiologist' from any portion of the label, labeling, or any other information which is distributed for consumer view," Plough said. The company noted that it will "delete from package 'end flaps' the term, 'Low Dose.'" Along with the letter, Plough submitted two "mock-ups" of proposed packaging that the company believed would address the agency's concerns. Regarding future promotional material, Plough said that it would be "especially mindful of the environment in which the product is sold [and] will not promote a dosage of aspirin . . . that is lower than that approved by FDA." In the reg letter, FDA stated that a flavored, chewable 81 mg aspirin tablet "has long been recognized" as the "standard oral pediatric dosage form for use as an analgesic." However, FDA noted, St. Joseph low dose adult aspirin "does not include directions for pediatric use" and, therefore, is "misbranded." "The aspirin product FDA continued, is "further misbranded in that its labeling is false and misleading, since the designation, 'Low Dose,' is incongruous with the labeled directions for use as an analgesic/antipyretic, which are comparable to standard adult dosages for aspirin."

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