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FDA deputy adds flesh to bones of new labelling regs

06-Oct-2005

New rules detailing an improved format for prescription drug labels will be issued later this year, US Food and Drug Administration deputy commissioner for medical and scientific affairs Scott Gottlieb has said.

"Right now, too much important medical information is poorly accessible today or not accessible at all because we have failed to adapt for healthcare simple IT innovations that have long permeated the workplace," he said in a presentation at the National Press Club in Washington DC.

Beginning in November 2005, healthcare professionals, patients, and other consumers will be able to access high-quality, up-to-date information on medications via the Internet free of charge through the Daily Med system, which will receive, distribute and display medication information that has been developed by Federal agencies.

"This is a monumental change in the way medical information is made available," said Gottlieb.

A key element of the Daily Med is an electronic version of the package insert. At the moment, the content and format of these paper labels is not conducive to easy accessibility, and they are not easy to search for pertinent information, or even find on the web, according to Gottlieb.

The FDA will release soon a new rule that would fundamentally re-make this package insert, or the physician label, making the information that is provided more readable, more accessible, and more amenable for electronic dissemination, he added.

The move, part of a broad program starting in November, is an important step toward creating an electronic environment for safety and effectiveness information, he said. From next month, drugmakers will have to provide label changes electronically and in a standard format, he noted, adding that the FDA is considering providing updated information on side effects of marketed drugs on a regular basis, perhaps even weekly.

"This is an important step toward creating an electronic environment for drug safety and drug effectiveness information that will make it easier for doctors and patients to get up-to-date information right at the point of care," noted Gottlieb.

However, not all are completely satisfied that these measures go far enough. Peter Lurie, deputy director of Public Citizen's Health Research Group, told Reuters that these ideas are good but the FDA also needs to approve more medication guides that explain risks and benefits to consumers in plain English.

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