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Orphan drug legislation

Executive Summary

Senate Labor & Human Resources Committee could schedule a markup as soon as this month on S 2060, Sens. Metzenbaum (D-Ohio) and Kassebaum's (R-Kan.) bill to set a $200 mil. sales "trigger" on orphan drugs. Once the trigger is reached, FDA could consider competitor marketing applications during a product's exclusivity period. Committee Chairman Kennedy (D-Mass.) also is looking seriously at "windfall" profits tax approaches to address concerns about big-selling orphan drugs.
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