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This article was originally published in The Gray Sheet

Executive Summary

THERAKOS PHOTOPHERESIS SCLERODERMA STUDY "UP AND RUNNING" under protocol developed jointly by FDA and photopheresis device manufacturer Therakos, Commissioner David Kessler testified at a March 16 hearing before the House Appropriations agriculture subcommittee. "What we have done," Kessler said, is "to sit down and work with the sponsor to work with the making sure that the study is adequately designed." A clinical trial under the new protocol "is up and running; it's in place, and it will answer the questions that we think need to be answered," he said. "We're on our way to getting the data, once and for all, on that product." The protocol was agreed to by Therakos and FDA during a Sept. 23, 1992 meeting ("The Gray Sheet" Sept. 28, 1992, In Brief). Therakos, the manufacturer of the UVAR plasma photopheresis device used in conjunction with ICN Pharmaceuticals' Oxsoralen (methoxalen) to treat severe scleroderma, had withdrawn its new drug application for the combination product after concluding that previously submitted data was not receiving a fair appraisal by FDA reviewers ("The Gray Sheet" Jan. 27, 1992, p. 29). Asked by Rep. Rosa DeLauro (D-Conn.) about the delay in approving the combination therapy, Kessler replied: "The unfortunate part about the photopheresis issue involving scleroderma is that the [earlier] studies...did not show in any convincing way that the therapy worked." The commissioner maintained that "when the data is there that shows that something works, we can move that product out, and that's what we need" to approve the treatment for severe scleroderma. Kessler acknowledged that women with scleroderma, which can be life-threatening, generally cannot get insurance coverage for unapproved treatment regimens like photopheresis. The answer, he said, is that health insurers should cover experimental products for serious illnesses when no alternative therapies are approved. The issue now for scleroderma patients "is what do we do in the interim; what do you do while you're waiting for the data, especially when people don't have time to wait?" he said. "There's no reason why, at least from our standpoint, insurance companies should not cover" experimental therapies "if patients have no other alternative," the commissioner asserted. "I can't mandate that coverage, but I have said repeatedly, in cases of life-threatening diseases or serious diseases, those kinds of therapies should be reimbursed."



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