FDA Delays Generic Drug Labeling Rule for Third Time

Originally published by Robert Kraft.

The New York Time reports the Food and Drug Administration will “put off until 2017 a decision about whether to require generic drug makers to take more responsibility for warning patients about the risks of their products.” The Times states that while consumer groups were “dismayed” by the FDA’s decision, the generics industry has said requiring such labeling “would create confusion because drugs that were equivalent could carry different warning labels.” As an alternative, the industry has proposed a cooperative effort between generic drug makers and brand-name companies “that would make the F.D.A. the final arbiter of label changes.”

STAT reports that the FDA “is delaying the debut of a controversial rule for updating generic drug labeling” for the third time since it was proposed in 2013. 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 rule is now expected to take effect in April of 2017.

From the news release of the American Association for Justice.

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