A view from the United States

Primary care pp 1311, 1312, 1313

Three papers in this issue, one from Germany and two from the Netherlands, highlight the problem of off label prescribing in children. 1 2 At first reading these manuscripts were a confusing “tower of Babel” for a reader from the United States, but the problem being discussed is all too familiar. In the United States the Food and Drug Administration has responsibility for the licensing process for all drugs. The term “approved” is used for a drug that has been deemed to have safety and efficacy for a particular disease process. Until recently, the drug need only to have been studied in the adult male population. Yet once a drug is approved it may be prescribed by a physician for any population or disease state desired. The term “off label” has been applied to describe the use of these drugs in either populations or disease states not listed as indicated in the package insert. While attempts have been made to use the term off label to imply recklessness in the medical malpractice arena, the American Academy of Pediatrics has …