Since 1997 the US reward pediatric studies with patent extensions; since 2007 the EU demands Pediatric Investigation Plans (PIPs) for new drugs. Without a PIP, EU approval is blocked. The demanded pediatric measures are based on the children-are- therapeutic-orphans and children-are-not-small-adults mantras. Babies are different from adults, but they mature. With growth their body matures. From 1997 on, companies profited from US patent extensions. The EU demands pediatric measures very early, while the reward is negligible. Minors are not another species that need repeated prove of efficacy. Young children need correct dosing. In life science industry it is an open secret that most FDA/EMA-demanded pediatric studies are questionable. Dr. Rose was the first to analyze that systematically. In this highly controversial topic massive conflicts of interest are involved.

Babies & infants cannot swallow tablets. Child-friendly formulations are the most reasonable part of regulatory demands. Technical development has accelerated
enormously. Dr. Poellinger will lead through these advance and how to reconcile preliminary formulations used in pediatric studies with the final market formulation.
FDA & EMA know that their demands are scientifically on shaky grounds. Companies should not be confrontational initially, but should be prepared to do so if necessary.
Negotiating FDA initial study plans (iPSPs) and EMA PIPs should not be a routine that accepts FDA/EMA justifications. Companies should push back to save millions and
avoid damage lawsuits.