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Executive Summary

SANDOZ "DEAR PHARMACIST" LETTER REQUESTING THIORIDAZINE ADVERSE REACTION INFO was criticized by FDA as an anti-generic campaign "to mislead health care professionals to believe that substituting approved generic forms of thioridazine to patients requiring such therapy will result in clinical failures or some other unexpected and unfortunate experience," a recent FDA reg letter. FDA Office of Drug Standards Director Peter Rheinstein, MD, told the company that it "may not state or imply that any clinical differences have been demonstrated between Mellaril and approved generic thioridazine products." FDA's letter was written in response to a May 21 "Dear Pharmacist" letter that states: "Due to the nature of a thioridazine patient's illness, differences in symptomatology may often be attributed to the illness rather than to drug product differences." The letter encourages pharmacists to report "differing patient response to various manufacturers' products" because such information "would be most helpful in determining whether or not an actual problem exists upon the interchange of thioridazine products." FDA noted that the letter includes an adverse reaction reporting form and stamped addressed envelope to Sandoz. Rheinstein asserted that the suggestion "that differences in patient symptomology should perhaps be attributed to product differences rather than only to the illness, is objectionable." He said it is "unlikely that a large majority of substitutions will be Mellaril for a generic product. Therefore, if most patient reactions are attributed to product variation as you suggest, they will be attributed to substitution of the generic product." With regard to pharmacist submission of ADR reports, Rheinstein declared: "Your efforts to suggest reasons for and accumulate increased numbers of reports for FDA's Drug Experience Program is viewed as a deliberate attempt to bias and commercialize a system FDA utilizes to detect unexpected drug hazards." The agency ordered Sandoz to cancel immediately any materials that convey deceptive information about the differences between Mellaril and generic thioridazine products. In addition, FDA requested Sandoz to prepare, with FDA assistance, a corrective letter to be sent out within 30 days of discussions with the agency. FDA has had ongoing discussions with Sandoz about its promotion of Mellaril for the past 18 months. In November 1983, the agency objected to an ad that suggested generic substitutes might result in unpredictable results because of "widely varying blood levels" that could occur between products. More recently, FDA said it became aware in March 1985 "of a report of clinical failure which was published in the Florida Pharmacy Journal, vol. 48, April 1984, which was being used as a promotional piece by Sandoz."

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