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ORPHAN DRUG EXCLUSIVITY LIMITS UNDER REVIEW AT FDA

Executive Summary

ORPHAN DRUG EXCLUSIVITY LIMITS UNDER REVIEW AT FDA, Solomon Sobel, director of the agency's Metabolism & Endocrine Drug Division noted in a recent deposition filed in Washington, D.C. Federal Court. "FDA is currently developing regulations that seek to define the scope of orphan drug exclusivity," Sobel said. According to FDA's Office of Orphan Products Development, the regulations are expected to be complete by year end. Sobel's testimony was taken on behalf of FDA, which is being sued by Genentech in connection with the agency's designation of Lilly's methionyl-free recombinant human growth hormone product, Humatrope, an orphan drug. While FDA is moving ahead in an effort to define the scope of orphan drug exclusivity through the development of regulations, Rep. Waxman (D-Calif.) has put Orphan Drug Act amendments on the back burner. Following the approval of Humatrope in March, Waxman was reportedly ready to introduce a bill in mid-April that would attempt to narrow the current law's definition of orphan drug and reconsider the issue of exclusivity ("The Pink Sheet" March 23, T&G-1). That bill was never introduced, and since late spring, Waxman and his Energy & Commerce/Health Subcommittee have been preoccupied with a revision of Medicare to include outpatient prescription drug coverage.
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