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