FDA unveils new prescription drug labels

WASHINGTON (AP) -- A major makeover is coming for the little written inserts that accompany prescription drugs. The new versions are supposed to play up information that's useful to pharmacists and patients while paring down the small-print legal disclaimers.
Confusing medical information is behind many of the estimated 300,000 preventable cases of death or injury that occur each year in the nation's hospitals, Surgeon General Richard Carmona said Wednesday in introducing the new drug labeling rules.
The rules should make it easier to quickly learn the most critical things about a drug, according to the Food and Drug Administration.
But the FDA's repeated assertions that the federally approved labels pre-empt state law alarmed some activists and legislators, who call that a curtailment of patient rights. The rules come amid a flurry of high-profile drug lawsuits, including cases involving Merck & amp; Co.'s painkiller Vioxx.
The guidelines seek to roll back additions made over the years that have made prescription drug inserts, intended for physicians but useful to patients, dense and difficult to negotiate, acting FDA commissioner Dr. Andrew von Eschenbach told a news conference.
"We are making the prescribing information much more targeted and useful for physicians," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations.
The American Medical Association applauded the FDA, saying it had long encouraged the regulatory agency to make labels more useful and user-friendly.
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