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# FDA Delays Generic Drug Labeling Final Rule Until 2017
- URL: https://www.fdaweb.com/fda-delays-generic-drug-labeling-final-rule-until-2017/
- Published: 2016-05-19T12:00:00.000Z
- Updated: 2026-09-14T21:04:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135715

FDA has again postponed its final rule on generic drug post-approval labeling changes, this time until 4/2017\. Public Citizen previously [criticized](http://fdaweb.com/login.php?sa=v&aid=D5134104&searchWords=generic%20drug%20labeling%20rule&cate=S&stid=%241%24yk..Te2.%24PGERYCe9aO0PEFP2Wd5qj%2F&ref=fdaweb.com) the agency for delaying the rule’s issuance until 7/2016\. The group has long complained (see earlier [news release](http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5746&ref=fdaweb.com)) that brand name drug manufacturers currently are permitted to make label safety updates without agency approval (changes being effected process), while generic drug manufacturers cannot update warnings to reflect new safety information unless instructed to do so by FDA. Now, a White House Office of Management and Budget [notice](http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG94&ref=fdaweb.com) indicates the rule has been delayed again, and without any explanation.

In response to a request for comment, an agency spokeswoman told ***FDA Webview*** that the completion dates for rules are “projected dates that may be adjusted to reflect ongoing work on specific rules.”

It is possible that FDA is using this extra time to evaluate an industry proposal that FDA adopt a science-based alternative that relies on the agency to review new safety information for multi-source products. “FDA is the only organization in the multi-source environment with full access to complete product safety information from the numerous manufacturers,” stakeholders said in a recent [letter](http://www.gphaonline.org/gpha-media/press/healthcare-supply-chain-raises-more-concerns-about-fda-proposed-changes-to-generic-drug-labeling?ref=fdaweb.com).