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Medicare Formulary Rules Add Bite to "Black Box" Warnings

CMS is sharply limiting the ability of Medicare plans to make formulary changes during a plan year-except when FDA demands a new warning. Though CMS says it doesn't want to interfere with FDA's regulation of drug safety, the policy is likely to complicate the already difficult labeling negotiations over new warnings.

The cost to pharmaceutical companies of adding a new "black box" warning to product labeling just got higher.

A black box, so named because the warning information is highlighted in a box placed at the top of the...

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