Tabor’s book, ‘Risk Evaluation and Mitigation Strategies for US Drug Development’, was recently launched with RAPS (Regulatory Affairs Professionals Society).
In it, he describes the REMS (risk evaluation and mitigation strategies) programme and how companies can dodge the hurdles of the application process, which has been in place since the US FDA (Food and Drug Administration) brought the strategy into play in 2007.
Speaking to in-PharmaTechnologist.com, Tabor told us that though some companies are still concerned about additional costs and delays of implementing the program the benefits outweigh the risks.
“One can view the REMS as a continuum of requirements ranging from informational such as medical guides or plans, implementation plans, and elements to ensure safe use abbreviated (ETASU) at the other end of the spectrum,” he said.
“The existence of REMS has in some cases allowed the drugs to be approved, the thinking being that the REMS provide the additional controls that prevent some of the risks that would be there without the controls.”
He added that though preparing REMS does cost money, the programme often speeds drugs to market, which means an extra year of sales at the time of peak revenue.