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Executive Summary

SEARLE "PATIENTS IN THE KNOW" PROGRAM OFFERS TAKE-HOME Rx INFO to patients through their physicians. Described by the firm as "the first comprehensive effort by a pharmaceutical company to provide easy-to-understand information about its prescription drugs to patients worldwide," the program will initially provide laymen's language information sheets for Searle's top three products, Cytotec (misoprostol), Calan (verapamil) and sustained-release verapamil (Calan SR). In a sample of instructions provided on Calan SR, Searle directs patients to "follow your doctor's instructions on how much and how often to take Calan SR." The sheet also states: "If you are being treated for high blood pressure, youmay not feel sick, and therefore you may decide to stop taking your medication. It is important to continue taking this type of medicine as directed for as long as your doctor prescribes it. High blood pressure can lead to many serious conditions, including stroke, heart disease, and kidney failure." The sheet contains a space for "special instructions from your doctor." Searle introduced the program to the medical community in early October and "already has requests for materials from over 5,000 physicians and nearly 10,000 pharmacists." Pharmacists also will be provided with pamphlets on prescription medicines in general for distribution to patients. The program will be launched in Canada in early 1990 and expanded to other countries when permitted by each country's regulations. The European Community is expected to require distribution of patient package inserts in 1992. The program was announced to the public at an Oct. 19 press conference on Capitol Hill. Chairman and CEO Sheldon Gilgore was accompanied at the briefing by Sen. Hatch (R-Utah), ranking minority member of the Labor & Human Resources Committee, and HHS Undersecretary Constance Horner, who both expressed support for the voluntary effort. Hatch said that while he hoped other drug companies would voluntarily follow the lead taken by Searle, he does not support legislation mandating the distribution of consumer information on prescriptions. Horner noted that mismedication is a government concern and pointed out that FDA and HHS Secretary Sullivan recently supported an effort initiated by the National Council on Prescription Information and Education to improve drug use among children ("The Pink Sheet" May 8, T&G-15). Gilgore noted that FDA had reviewed the materials and was satisfied with their content. However, he pointed out that since the consumer information is not required by FDA, the materials do not need agency approval prior to distribution. The "Patients in the Know" program is the third consumer-oriented promotion instituted by Searle in the past three years. The company announced a "Patient Promise" refund program in the fall of 1987, in which Searle offered full refunds to patients for whom a Searle product is prescribed but "does not achieve the desired therapeutic benefits." Sen. Hatch also participated in the announcement of that program. In the winter of 1988, Searle launched a "Patients in Need" giveaway program for indigent patients. Through that program, Searle has distributed free Calan, Calan SR, Cytotec and other drugs with a retail value of over $8 mil.

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