New US FDA distribution rules for off-label Rx drug information to physicians

The US Food and Drug Administration's Office of Policy has published Good Reprint Practices for the distribution of medical journal articles  and reference publications on the unapproved new uses of otherwise  approved drugs. The guidance document is intended to present the  agency's "current thinking" without being binding on the FDA or the  public, the FDA said in a statement.

Previous FDA rule lapsed in 2006

The basis for the move is that, under Section 401 of the FDA  Modernization Act, drugmakers were provided with certain conditions  under which they could claim a "safe harbor" for information  disseminated about off-label uses of prescription medicines. This meant  that a presumption could be made that the circulation of scientific  journal articles would not be considered to be an unlawful marketing  exercise. Pharmaceutical firms were not obliged to use the provisions.  However, the legislation under which these arrangements operated lapsed  in September 2006.