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Executive Summary

UPJOHN GLYNASE PRESTAB CORRECTIVE LETTER TO 10,000 INDEPENDENT PHARMACIES and 10 drug store chains informs pharmacists that "patients switched to Glynase PresTab from other oral hypoglycemic products may incur certain risks and additional costs and inconvenience associated with laboratory testing and monitoring required with retitration until a new appropriate dosage regimen is established." FDA requested the corrective action in a November warning letter ("The Pink Sheet" Dec. 7, 1992, p. 3). The March 12 letter is being sent to pharmacies that were contacted about the Upjohn Diabetes Cognitive Services Reimbursement Program, which paid pharmacists to encourage the switching of patients to Glynase PresTabs (glyburide) from other oral hypoglycemic agents including Upjohn's older glyburide formulation Micronase. The letter will be sent directly to independent pharmacists, while the chain drug stores will be asked to distribute copies to their pharmacists. A copy of the letter will run in four pharmacy journals. Upjohn is sending a "Dear Doctor" letter on Glynase PresTabs to approximately 150,000 physicians who are high prescribers of hypoglycemic drugs. Upjohn is also sending a letter to other physicians whose patients were switched as a result of pharmacy contact. A copy of the "Dear Doctor" letter will be published in eight medical journals. As of February, the company reportedly had identified almost 2,000 prescriptions filled by independent pharmacists under the program, although that number could increase as reimbursement forms continue to be submitted. The firm also was aware of about 4,500 scripts filled by chains. FDA did not ask the company to contact specific patients who were affected. The text of the various "Dear Doctor"/"Dear Pharmacist" letters includes a series of six statements requested by FDA, including: "Patients' dosages should be retitrated when they are switched to Glynase PresTab"; "No exact dosage relationship exists between Glynase PresTab and other oral hypoglycemic agents"; "Bioavailability studies have demonstrated that Glynase PresTab" may not be bioequivalent to Micronase; "Inappropriate dosage could cause the loss of diabetes control in clinically stable patients"; "Patients should be informed of the potential risk of hypoglycemia"; "The patient's blood glucose should be monitored periodically." FDA's warning letter cited Upjohn for not submitting materials distributed as part of the program "in a timely manner." Upjohn revised its procedures for submission of promotional materials in response to the letter. Upjohn met with FDA to discuss its proposed corrective campaign on Jan. 14. While the company discontinued the program in response to FDA's letter, Upjohn is understood to have told the agency it still believes reimbursement to pharmacists for "cognitive services" is appropriate. FDA said it is only concerned about payments to pharmacists when the intent is promotional. The agency cited Lederle's ProStep nicotine patch pharmacist counseling program as an example of an acceptable practice. Upjohn is also understood to have said that promotions for all oral hypoglycemic agents should point out that retitration is necessary whenever patients are transferred from one agent to another. Upjohn is seeking a meeting with the Endocrine and Metabolism Drug Products Division to discuss the retitration issue.

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