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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.


The agency first proposed its rule two years ago following a 2011 US Supreme Court decision that federal law does not permit generic drug makers to make changes to their warning labels independently. Consequently, the court ruled that generic drug makers should not be held accountable for a failure to warn against a safety risk.

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  • Hi Leonarda
    Pharmalot has been around nearly 10 years and has switched venues more than once, most recently going to STAT. During this time, the comments section has generally served as the type of sounding board you are seeking. However, we only turned on the comments this week, so it will eventually gain traction. Meanwhile, no, I don’t know of a forum or listserve of the sort you are seeking. But thanks for taking the time to stop by.

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