Following the Contergan disaster in the 1960s statutory regulations governing the safety testing of pharmaceuticals were significantly tightened in many countries. Children whose mothers had taken during pregnancy the sleep aid and tranquillizer Contergan (active agent: thalidomide) developed and marketed by the company Grünenthal exhibited a high rate of severe limb deformities. In his paper Shirkey refers to the "unfortunate twist of fate" under which the call for extensive testing of new substances has led to many drugs coming onto the market with an exclusion clause prohibiting their use on children because child-specific tests have not been carried out.

It is, however, widely held that regulatory difficulties are not the only reason for a lack of clinical trials. The financial profits that can be generated with drugs for minors are considerably smaller than those that can be earned with pharmaceuticals for adults. As a result, drug companies operating according to free-market principles devote less attention to research on children (cf. Boos 2005: 56).