In a Federal Register notice today, the FDA announced the outsourcing FY 2019 fees (here) for regular and small business establishment fees and for the reinspection fee. FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019 and will be subject to establishment fees. Qualified small business facilities pay 1/3 on the establishment fee.
With the inflation and other factors that are used to calculate the new FY fees, the structure of the fees are presented below for FY 2019.
Outsourcing facilities that experience cGMP issues are subject to the reinspection fee, but this is a difficult number to predict. There is no reduction in the reinspection fee for small business entities.
The cost for fees in all of the Agency programs keep going up, as the dialog about increased prescription drug costs continues. The fee costs are likely passed onto the consumer. This seems to be a vicious circle and, at some point, it will impact the ability of smaller firms to compete and enter the various markets for which the fees are incurred, and will certainly add to the increased prescription charges patients will pay.
