FDA Scraps Controversial Generic Drug Labeling Rule, Weighs Next Steps

FDA on Thursday (Dec. 13) scrapped a controversial generic drug labeling proposal that would have allowed generic drug makers to update their drug labels with new information independent of labeling changes to the brand reference product. At the same time, FDA officials announced a new program to update labels on certain generic cancer drugs, and said they were discussing with Congress a possible need for new resources or authority to address outdated labels. The proposed generic drug labeling rule had...