FDA roadmap highlights opioids, gene therapy, biosimilars
In December 2017, the Food and Drug Administration (FDA) revealed its 2018 goals, reflecting Commissioner Scott Gottlieb’s priorities. The FDA’s 2018 strategic policy roadmap highlights the battle against opioid addiction, the growth of cell and gene therapy, and using competition to improve access and make drugs more affordable.
The latter piece of the agenda includes promoting more generics and biosimilars to tame high drug prices, which pharma is “inappropriately impeding.” Final guidance on communication from developers to payers about economic consequences of products is also expected in order to promote value-based contracting.
