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Goal of drug labeling rule is clearer inserts

In another step, the Institute of Medicine has been meeting to assess the FDA's drug safety record.

By Susan J. Landers, amednews staff. Feb. 6, 2006.

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Washington -- The Food and Drug Administration's long-awaited prescription drug labeling rule was unveiled Jan. 18, and with it came hope that long and complex package inserts will be replaced with physician-friendly inserts that highlight the essentials -- dose, risks, contraindications and potential drug interactions.

The new rule is intended to give clear and concise prescribing information, according to FDA officials. This information is to be provided in an easy-to-read format with the most important data in a prominent half-page "highlights" section at the top.

The rule takes effect June 30 for new drugs. Drugs approved during the previous five years will be gradually phased in, and older drugs will be included only if there has been a major change in prescribing information.

Physicians long have criticized the lengthy package inserts that have morphed over the past decade from useful tools into lengthy and complex legal documents. The superabundance of material they contained often overshadowed the data physicians needed to find quickly.

The AMA applauded the new rule.

"We hope that the new prescription drug information format will help physicians better access and communicate important drug information for their patients," said AMATrustee Edward Langston, MD.

"The AMA has long encouraged the FDA to update the prescription drug package insert to make information more useful and user-friendly to physicians," Dr. Langston said. The Association has testified before Congress and before the FDA about the need for such improvements.