tci Medicare Compliance & Reimbursement - 2006 Issue 6

PHYSICIANS: Prescription Drug Package Inserts Get A User-Friendly Makeover

Long-overdue redesign improves information but sparks controversy.Physicians may soon find prescription drug labeling information a much more useful tool--but critics worry that the Food and Drug Administration's package insert revisions conceal a hidden agenda.The potential revisions, which would take effect June 30, 2006, are the first significant changes to package inserts in 25 years and will apply to all new drugs, as well as those the FDA approved within the last five years. FDA hopes the changes will help reduce medication errors, improve physicians' abilities to locate important information about drugs' risks and benefits, and increase adverse...

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