FDA demands digital, online drug labels

WASHINGTON - Drug makers must begin submittingelectronic versions of their drug labels to build a databasethat doctors and patients can search for recent warnings orother changes, the U.S. said onWednesday.

The labels will be available on the Internet within onebusiness day of any FDA-approved change athttp://dailymed.nlm.nih.gov, FDA officials said in a statement.

"With this information, physicians will be able to quicklysearch and access specific information they need beforeprescribing a treatment, allowing for fewer prescribing errorsand better informed decision making," the FDA said.

Digital versions of drug labels must be provided to the FDAwhen either a label change is made or as part of a yearlyreport that pharmaceutical companies provide the agency.

It will take a year for the roughly 9,000 U.S.-approvedprescription drugs to have their new labels put online, FDAspokeswoman Kristen Neese said.

Drug labels are usually designed as small pamphletsincluded with the medicine and are known for their 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 underspecific conditions.

The FDA says the new Internet format will allow people tomore easily navigate through the information by jumpingdirectly to certain sections.

The FDA will next require similar digital label formats fornonprescription drugs and eventually for medical devices,animal drugs, some food products and biologic drugs such asvaccines, said Neese.

yahoo.com/