The ink is barely dry on a February draft guidance dealing with distribution of scientific materials reviewing off-label use of drugs and devices, but FDA has agreed to address a citizen's petition seeking greater clarity on this and other First Amendment issues. The news comes at a time when case law is in a state of churn and FDA thus faces an uncertain legal landscape in its efforts to apply the statute. However, Mark Gardner of DuVal & Associates (Minneapolis) told Medical Device Daily the agency may end up responding to the petition by citing existing guidances despite FDA's promise to "evaluate the need for additional guidance and new or modified regulations" for the issues at hand. Read More
