FDA Sets Facility Registration Fees for Manufacturers of Generic APIs, Finished Dosage Forms
The US Food and Drug Administration (FDA) has published the user fee rates for facilities that manufacture active pharmaceutical ingredients (APIs) and finished dosage forms (FDF) for the current fiscal year, part of the agency's new authority under the FDA Safety and Innovation Act (FDASIA).
In July 2012, FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the active ingredients for generic drugs and those just turning the active ingredients into its finished form by combining them with excipients or other additives.
That fee structure, contained within a provision of FDASIA known as the Generic Drug User Fee Act (GDUFA), divides one lump sum-$249 million ($299 million minus a $50 million one-time backlog fee)-into several parts, of which API and FDF manufacturers are collectively responsible for 70%.
FDF manufacturers will be on the hook for 56% of the total facility fees, or $139,440,000, which is then divided by the number of facilities registered with FDA. The Federal Register notice indicates that 759 facilities have registered with FDA as of the time of posting, of which 325 were domestic facilities and 433 were foreign.
Facilities located outside the US will be required to pay an additional $15,000 in fees meant to partially offset the costs of maintaining a global regulatory presence to conduct regulatory inspections.
The base fee-not counting the $15,000-will be $175,389 per facility per year. Foreign facilities will need to pay $190,389 per facility per year.
API facility fees are determined in the same manner. API facilities will pay 14% of the total facilities fees, or $34,860,000. By FDA's accounting, there are 122 domestic and 763 foreign registered facilities, of which the latter will be required to pay the same $15,000 premium for yearly facility registrations-a far higher burden relative to the total cost for API manufacturers than for FDF manufacturers.
The base fee for registering an API manufacturing facility with FDA in fiscal year 2013 will be $26,458. Foreign facilities will be required to pay $41,458 per facility per year.
Fees are due to FDA by 4 March 2013, and may be submitted on FDA's website at this webpage.