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FDA's Unlikely Defenders

This article was originally published in RPM Report

Executive Summary

The primacy of FDA-approved labeling has an unlikely advocate. The Washington Legal Foundation is joining the EPO coverage dispute to tell CMS not to step into FDA’s turf.

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Amgen, J&J and a host of supporters urged CMS to wait until FDA completes its safety review of EPO before acting to limit coverage. CMS is having none of it.

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Amgen and J&J have billions of dollars at stake in the battle to convince CMS to change its coverage proposal for EPO in cancer patients. Win or lose, their efforts will be a valuable case study for any other manufacturer that fi nds itself facing an adverse reimbursement policy.

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