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.
The delay comes one month after the House Appropriations Committee proposed a spending bill that would prevent the FDA from using its funding to enact the rule as early as this summer. At the same time, more than a dozen companies and organizations urged the FDA not to proceed over concerns a potpourri of labels would result. Among them were CVS and trade groups representing health insurers, pharmacists, and pharmaceutical wholesalers.
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