The draft rules on labeling updates are now a reality. Next month, regulations about safety warnings will take effect, aimed at offering clarity for drugmakers and increased confidence among patients, the FDA says. Critics say the new regs could shield drugmakers from product liability suits.
One new rule in particular states that companies only have to rush out safety warnings when there's clear evidence of a serious risk that the FDA hasn't reviewed. In every other case, FDA will review safety data and consider labeling changes after that.
A lawyers' association (which of course has its own vested interest) says the rule sets the bar too high for the scientific evidence needed to impel a warning. The group says that will make it easier for drugmakers to say they weren't obligated to alert the public about a particular safety risk. "This rule is going to be a total shield against all 'failure to warn' claims," the association's director said.
The big Vioxx case, for instance, alleged that Merck failed to warn consumers about the painkiller's heart attack and stroke risks. That lawsuit wouldn't have been possible under this new rule, according to the lawyers' association.
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