New Labels for Drugs Promised

On September 23, 2005 the FDA announced that new prescription drug labels will be easier to read and updated quickly on the Internet. This all comes as part of an effort to improve information for doctors and patients.

Regulators have been promising a major revamp of prescribing instructions for years. Labels for physicians sometimes run several pages with side-effect information scattered throughout. In addition, it can take months for new warnings to be added.

Rules outlining a new format are expected to be issued soon. Official hail such revisions as an important step toward creating an electronic environment for drug safety and drug effectiveness information. Drug makers will have to submit changes to their product labels electronically starting in October 2005 in a standard format that will hasten the updating process. This step is part of a broader program that will begin in November to make important information readily available by electronic means such as over the Internet or through personal digital assistants. The agency also is considering a policy of releasing regular updates, perhaps weekly, about side effect reports for drugs on the market.

The FDA has been attacked as being too slow to respond and warn the public about signs of serious side effects from some medicines. Two agency scientists went public with charges that their supervisors downplayed or suppressed their concerns about antidepressants used by children and Merck & Co. Inc.'s recalled arthritis drug Vioxx.

Article References
New labels for medicines coming soon, site accessed on 10/22/05