In 2006, the European Council (EC) and the European Parliament adopted a regulation that created major changes in the way clinical studies in pediatric patients would be planned and conducted in the EU. For many years, clinical evaluations of drugs and biologics were conducted primarily in adults because it was simpler and raised fewer ethical concerns than conducting studies in children. Nevertheless, following regulatory approval for use in adults, these products were often prescribed for children despite the lack of clinical trials in this population. Physicians often used an empirically selected lower dose based on the weight of the child. In some cases, this could have resulted in exposure to unsafe or ineffective doses because children may metabolize a drug or biologic differently than do adults.

Regulatory Focus 15:11:39–44, 2010.