The Food and Drug Administration (FDA) has made available a draft guidance titled “Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” that would provide information on new statutory provisions authorizing the agency “to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved.” Comments on the draft are requested by July 12, 2011.

The draft sets out how the agency will implement its authority, “including a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.” Before Congress changed the law, FDA learned about the potential for serious risks from a variety of sources and requested that product application holders make labeling changes. “In most cases, application holders responded to these requests by negotiating appropriate language with FDA staff to address the concerns, and then submitting a supplement or amended supplement to obtain approval of the changes.” According to the agency, the process was often protracted, and FDA “had few tools available at its disposal to end negotiations and require the changes.”