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Executive Summary

SANDOZ MELLARIL/GENERIC THIORIDAZINE INTERCHANGEABILITY information -- not an "anti-generic message -- was the goal of a "Dear Pharmacist" letter sent by the firm last spring, Sandoz Vice Chairman/CEO Max Link said in an Oct. 4 letter to FDA. Link wrote FDA Div. of Drug Advertising Director Lloyd Millstein, PhD, that the Sandoz "letter to pharmacists neither states nor implies that clinical differences have been established when thioridazine HCl drug products are interchanged. What the letter seeks is 'information that would determine whether or not an actual problem exists upon the interchange of thioridazine products.'" Link was responding to a Sept. 5 FDA reg letter regarding a Sandoz mailing in May 1984 to pharmacists. FDA noted that the "Dear Pharmacist" letter encouraged pharmacists to report "differing patient response to various mfr. products" because such information "would be most helpful in determining whether or not an actual problem exists upon the interchange of thioridazine products." FDA told the firm that it viewed the letter to pharmacists 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." FDA also noted that the firm had repeatedly been advised that it "may not state or imply that any clinical differences have been demonstrated between Mellaril and approved generic thioridazine products" ("The Pink Sheet" Sept. 23, T&G-2). Link maintained that the company's intent was "not to confuse health care professionals, but rather to determine whether a clinical problem exists." As support for the firm's position, Link noted that prior to the May letter Sandoz had forwarded to FDA a number of reports of clinical adverse effects associated with thioridazine substitution. "The overwhelming majority of these reports indicated an exacerbation of psychiatric symptoms upon interchange of drug products," Link said. By enclosing in its mailing to pharmacists copies of FDA's Form 1639; the agency's adverse experience reporting form, Sandoz' goal was to facilitate the gathering of information on the interchangeability question, Link said. He declared: The agency's statements that Sandoz has deliberately biased and commercialized a system that the FDA uses to detect unexpected drug hazards and that Sandoz is attempting to create the impression that FDA-approved generic drugs are not safe and effective as their brand name competitors are unfair to Sandoz and inaccurate." Link said that the objective of the data submitted to FDA is to get the agency to give thioridazine a BP rating, which indicates therapeutic inequivalence. The agency currently classifies thioridazine AB, indicating that different mfr. products are therapeutically interchangeable. The distribution of the FDA adverse experience report forms, Link states is "not the commercialization of an agency data collecting system but rather an attempt to collect important scientific data in a manner consistent with and in compliance with regulations." Link added that "we fail to understand how the agency can, in one breath, accuse Sandoz of making claims without sufficient supporting clinical data -- an accusation which is false -- and, in the next breath, criticize Sandoz for seeking relevant clinical information." In response to the agency's request for Sandoz to prepare, with FDA assistance, a corrective letter to be sent to pharmacists, Link said: "We strongly believe that 'corrective action'. . .is not warranted nor can it be considered in isolation from the clinical data which we have repeatedly submitted to the agency and our pending request for a BP rating for thioridazine HCl products." The firm is requesting a meeting with FDA officials including Office of Drug Standards Director Peter Rheinstein, MD, Office of Drug Research and Review Director Robert Temple, MD, and Chief Counsel Thomas Scarlett.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1985 F-D-C Reports, Inc., The Pink Sheet, October 7, 1985

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