Current Edition

FDA/EMA-triggered Paediatric Studies Do Not Advance Child Healthcare

Both the US Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) request/demand clinical studies in
children sponsored by the pharmaceutical industry, claiming
that off-label use of drugs in children is unsafe. Most FDA/EUrequested/demanded
paediatric studies are regulatorily justified, but
are medically senseless, and many even harm patients by keeping
them away from innovative efficacious treatment. Klaus Rose at
Klausrose Consulting reckons that most paediatricians are unaware
of this background and we should let them know. With their help, it
will be easier to suspend and terminate such studies, differentiating
between reasonable studies that advance child healthcare and
questionable studies triggered by regulatory obsession.