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SENATE FDA REFORM BILL DEMOCRATIC SUPPORT CONTINGENT ON CHANGES TO "HAMMER," CONTRACTING OUT PROVISIONS; OFF-LABEL DATA DISSEMINATION LANGUAGE DROPPED

This article was originally published in The Gray Sheet

Executive Summary

Moderation of the FDA performance enforcement mechanism and contracting out provisions of Senate Labor and Human Resources Committee Chair Nancy Kassebaum's (R-Kan.) comprehensive FDA reform legislation (S 1477) likely will be necessary in order to maintain Democratic support for the measure. The three Democrats voting in favor of the bill during Labor Committee mark-up March 28 said their support was contingent on further changes.
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