FDA again Delays Rule to Allow Generic Drug Makers to Change Labels
May 23, 2016
(STAT News) – Once again, the US Food and Drug Administration is delaying the debut of a controversial rule for updating generic drug labeling. The rule would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission. The agency never set a specific introduction date, but the rule was widely expected to be introduced this spring. But on Wednesday, a notice indicated the publication date was extended until April 2017. In fact, this marks the third time since the FDA proposed its rule in 2013 that the rule has been delayed amid opposition from the pharmaceutical industry and some lawmakers.