After years of debate, the Food and Drug Administration has withdrawn a rule that would have allowed generic drug makers to unilaterally update their product labeling when they learn of new information.
In explaining its reasons, the agency worried the rule could create “unintended consequences” by confusing patients and doctors if some generic companies did not revise labeling on a timely basis, or if generic and brand labels appeared different. FDA officials also pointed to concerns expressed by generic makers that they would have to raise prices to cover added costs for complying with the rule.
“This is a very careful balancing act,” FDA Commissioner Scott Gottlieb said in a media call. “The rule would have imposed some costs and burdens…. There would have been potential drawbacks and downsides. It’s one of the reasons we may look toward Congress and broader efforts to get additional resources to do the things we currently can’t do.” He noted, however, the agency plans a new program to update labels on certain generic cancer drugs.
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