Tuesday, December 8, 2015

FDA delays implementation of the generic drug labeling rules until July 2016 (at least)

Back in November, 2013, I posted that the FDA proposed a new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products.  Go here for my most recent post on the background on the controversy.

The rules were supposed to be finalized this month, but the FDA recently confirmed that implementation of the generic drug labeling rules will be delayed until at least July 2016.  This is not entirely surprising given the tremendous pressure the pharmaceutical industry has exerted on this issue and since it has taken this long to even get to this point.  It is disappointing, though, since the announcement back in 2013 gave some hope that the FDA would do something to improve the current state of the law.

As reported in AboutLawsuits.com, "[t]he prominent consumer watchdog group Public Citizen criticized the move in a press release issued December 3, indicating that the FDA’s decision to once-again delay implementing rules originally proposed several years ago, which would allow generic drug makers to up date their warning labels, will place consumers at serious risk."

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