FDA Delays Proposed Rule on Generic Labeling

for the second time, the Food and Drug Administration has delayed a controversial rule for updating generic drug labeling that would allow generic drug makers to independently update safety warnings, something only brand-name drug makers can currently do before receiving regulatory permission.

In a notice published in the Federal Register, the agency said the rule will be published in July 2016. The FDA originally planned to publish its rule late last year, but then delayed publication until this fall. The delay came amid push-back from the pharmaceutical industry, as well as some congressional lawmakers who questioned whether the agency has the authority to issue such a rule.