Once again, a controversial rule for updating generic drug labeling is being postponed, but this time, its chances of being implemented appear slimmer than ever, according to consumer advocates.
The rule was proposed four years ago by the Food and Drug Administration in an effort to bolster patient safety. Specifically, the rule would allow generic drug makers to independently update safety warnings, something only brand-name drug makers can currently do before receiving FDA permission.
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An administration that is against any new rules, coupled with extensive pharma lobbying leave me to observe that this really is dead. Somehow I don’t see the new Commissioner picking this hill to die on….. unless of course a few other people do and then things may change.