FDA issues draft guidance on promotion of off-label uses

In February, the Food and Drug Administration issued a draft guidance, “Good Reprint Practices,” that would allow drug and device companies some leeway in off-label promotion. The guidance would permit companies to give doctors reprints of articles from medical journals about unapproved uses of drugs and devices, within certain parameters. The proposal is similar to guidelines that were in effect since the late 1990s, but expired in 2006.