The FDA has announced the withdrawal of the proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” published in the Federal Register of Nov. 13, 2013. It is withdrawn as of Dec. 14, 2018.
The FDA is taking this action in light of concerns expressed by commenters—which reflect significant competing interests—and the agency acknowledges that the proposed rule, if finalized, would present significant potential downsides. The agency does not believe that finalizing the proposed rule would be an appropriate use of agency resources. Rather, such resources would be better used on other efforts to improve the communication of important, newly acquired drug safety information to health care professionals and the public.
The FDA continues to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle. The withdrawal doesn’t alter the obligation for holders of marketing applications for drug and biological products to ensure labeling is not misleading.