US, foreign API facilities to see FDA fees spike in 2015

04-Aug-2014 - Last updated on 05-Aug-2014 at 13:58 GMT

Related tags Food and drug administration Generic drug

US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.

The rise in fees for FY 2015 was not as steep as it was in 2014, when FDF companies saw a more than $40,000 increase, while API facilities saw an $8,000 increase.

In the most recent tally, 795 API facilities identified themselves to the FDA through self-identification, which was down from the 903 identified last year. Of those, the 103 domestic facilities (down from 148 facilities) will pay $41,926 each, while the 692 foreign facilities (down from 775 facilities last year) will pay $56,926 each.

Domestic FDF facilities will each pay $247,717 in FY 2015, and foreign FDF facilities will each pay $262,717.

The total number of FDF facilities identified through self-identification was 681, which was down from 748. Of the total facilities identified as FDF, there were 271 domestic facilities (down from 315 facilities a year ago) and 410 foreign facilities (down from 433 facilities in 2014).

The other generic drug fee rates for FY 2015, which will be in effect from Oct. 1 thru Sept. 30, 2015, include: ANDA (Abbreviated New Drug Application):$58,730; PAS (Prior approval supplement): $29,370; DMF (Drug Master File): $26,720.