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SENATE FDA REFORM BILL WILL COST FDA $555 MIL. OVER SIX YEARS, CBO ESTIMATES; $430 MIL. WOULD STEM FROM PRODUCT REVIEW "HAMMER" PROVISION

This article was originally published in The Gray Sheet

Executive Summary

The Senate FDA reform bill's "hammer" provision setting strict deadlines for FDA to reduce premarket submission backlogs and meet statutory review deadlines would cost the agency $430 mil. in additional resource expenditures and staffing over six years, the Congressional Budget Office estimates in its scoring of the reform bill (S 1477) reported out of the Labor and Human Resources Committee June 20. Overall, CBO foresees the agency incurring six-year costs of $555 mil. due to the measure.

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