More Me-Too Drugs Please, FDA’s Jenkins Asks Industry
This article was originally published in The Pink Sheet Daily
FDA’s top new drug official called out industry’s innovation model, noting that major primary care markets are being left underserved as sponsors focus on precision medicine and rare diseases.
You may also be interested in...
Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles.
Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.
FDA's drug center posted yet another record-breaking year for novel approvals, clearing 45 new molecular entities and therapeutic biologics, with big increases in orphan drug and breakthrough therapy approvals but few me-too drugs for common conditions. Is pharma's focus on unmet needs shortchanging public health?