Methodology for the Evaluation of Drugs in Pregnant Women
Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France
2 Schering-Plough, Levallois-Perret, France
Accepted: 26 May 2003
Although drugs are prescribed during pregnancy with some reluctance, they fulfil a real need in some circumstances. Adequate drug evaluation is thus essential, either based on efficacy and safety or mainly safety, using available data from non-pregnant women. Evaluation methodology is not fundamentally different during pregnancy. Recommendations for drug development are formulated on the basis of the most common situations as well as specific suggestions, thus raising the awareness of the different partners participating in healthcare (institutions, the pharmaceutical industry and prescribers). In particular, regulatory and economic incentives superimposed upon those recommendations adopted in Europe and the US for orphan diseases should be put into place to assist in the evaluation of drugs used in obstetrics. Medical needs in obstetrics should be better identified, and labelling of drugs for use during pregnancy should be better directed towards prescribers; a national registry of pregnancies should be established in France.
Key words: drug / pregnancy / evaluation / regulatory incentives
© Société Française de Pharmacologie, 2003