Testing new pharmaceutical products in children

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7380.64 (Published 11 January 2003) Cite this as: BMJ 2003;326:64

A positive step, but ethical concerns remain

  1. Alastair G Sutcliffe, senior lecturer in paediatrics
  1. Royal Free and University College Medical School, London WC1E 6BT

    Ideally all medicines that could benefit children should be licensed for this purpose. To date this has been the exception rather than the rule, resulting in children becoming therapeutic orphans sometimes with tragic consequences. Many medicines prescribed for children, whether in hospital or primary care, are either unlicensed or off label (used for an indication, age, dose, or route of administration outside the terms of the product licence). 1 2 Other problems surround the prescribing, dispensing, and administering of medicines to children.3 Many difficulties could be overcome if manufacturers were obliged to test their products on children as well as adults.

    In the United States a “carrot and stick” approach has been adopted to achieve this end.4 The carrot is the “paediatric exclusivity provision,” which grants an additional six months of patent protection or market exclusivity to companies that voluntarily test the relevant drug on children. The stick is the “paediatric rule,” a later requirement by the Food and Drug Administration that companies test their products on children under certain circumstances. …

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