FDA wants digital labels on all drugs - might solve the problem of very small print

Nov 3 2005

The U.S. Food and Drug Administration is requesting drug manufacturers submit electronic versions of their drug labels in order that a database can be established for doctors and patients to search for recent warnings or any other changes.

FDA officials say the labels will be available on the Internet within one business day of any FDA-approved change at http://dailymed.nlm.nih.gov.

The FDA says that with this information, physicians will be able to quickly search and access specific information they need before prescribing a treatment, allowing for fewer prescribing errors and better informed decision making.

It will be required that digital versions of drug labels must be provided to the FDA when either a label change is made or as part of a yearly report that pharmaceutical companies provide the agency.

FDA spokeswoman Kristen Neese estimates that it will take a year for the roughly 9,000 U.S.- approved prescription drugs to have their new labels put online.

Currently drug labels are usually designed as small pamphlets included with the medicine and are notorious for their very small print.

The labels include information on how the medicine works, what dose patients should take, possible side effects and, sometimes, warnings against its use in certain people or under specific conditions.

According to the FDA the new Internet format will allow people to more easily navigate through the information by jumping directly to certain sections.

Neese says ultimately the FDA will require similar digital label formats for nonprescription drugs and eventually for medical devices, animal drugs, some food products and biologic drugs such as vaccines.