Equal protection under the law: Children and the Best Pharmaceuticals for Children Act

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme, timing and submission of paediatric plans, and the per­manence of the legislation. Submitted: 30 November 2011; Revised manuscript received: 2 March 2012; […]


Generic and therapeutic orphans

Abstract:  This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts to provide drug therapy to children are briefly reviewed. Some examples of the inability of the current generics and non-generics pharmaceutical industry as […]