FDA's Unlikely Defenders

 
• By Michael McCaughan
  
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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.

Oncologists are definitely not happy about the Centers for Medicare & Medicaid Services’ proposed coverage restrictions for erythropoietin therapies. The agency received more than 1,800 comments on its draft policy, most from oncologists—and virtually all opposed to the changes. (See "Living in a Bipolar World," in this issue Also see "Living in a Bipolar World: Implications of the EPO Safety Debate (Part 1) " - Pink Sheet, 1 July, 2007..)

CMS’ policy is "dangerous," "poorly thought out," "deeply flawed," "too restrictive," "an injustice to patients," and "radical," the oncologists think....

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