New drug labels: Easing information overload

The American Medical Association applauds the Food and Drug Administration's attempt to make medication package inserts easier for physicians to digest.

Editorial. March 13, 2006.

Each year the Food and Drug Administration approves more than 100 new drug applications, including about 30 medications never before marketed in any form. The agency also gives the nod to more than 100 new or expanded uses for existing medications.

On top of that, special black-box warnings are attached to some drugs' labeling information. The agency is currently pondering adding such an alert to the package inserts for drugs that treat attention-deficit/hyperactivity disorder. Hundreds of medications have these special warnings.

Keeping up to date on this ever-changing prescription drug landscape is overwhelming for physicians.

Ironically, the package inserts that come with these medications have become so dense, lengthy and complicated that they are almost impossible to navigate, let alone absorb. Instead of serving the original intent as a tool to give doctors information they need about a medication, package inserts have become largely a legal document aimed protecting drugmakers.

Fortunately, the FDA has recognized the problem and is trying to do something about it. The agency last month came out with new rules for prescription drug labels -- the first revision in more than 25 years.

The American Medical Association, which long encouraged the agency to update the package insert to make it more user-friendly for doctors, has applauded the move. The Association has testified before Congress and the FDA about the need for these improvements and adopted policy in 2005 urging the agency to publish final drug label rules.