Friday, September 23, 2011

GDUFA Guidelines fixed - Should weed out smaller players, as it will increase the cost for generic players in the US


GDUFA negotiations have been recently completed.  The additional funding called for under GDUFA is an inflation-adjusted $299 million annually for each of the five years of the program. This amount will be split between finished dosage form manufacturers and active pharmaceutical ingredient manufacturers.

Fees will be derived from both applications and facilities in a 30%-70% split. Fees will be split between finished dosage form manufacturers and active pharmaceutical ingredient manufacturers in an 80%-20% split. With about 200 ANDA applications filed annually the fees per ANDA should come to around half a million per ANDA application. The fees for Post Approval Supplements (PAS)  would be half of the ANDA fees. While A USFDA approval for its finished dosage facility would become a costly affair for a generic company.  About $170m annually would come from the finished dosage facilities having USFDA approval / requiring a USFDA approval.  Globally there are 1000 USFDA approved Finished dosage manufacturing facilities and these will share the additional burden.


·         Application Fees – Include backlog fees in year 1 and ANDA and PAS fees, as well as DMF first reference fees, in all years.


·         Facility Fees – Will be paid by both finished dosage form manufacturers and API facilities with a modest fee differential reflecting the added costs of overseas inspection.

Source of Fees – The percentage to be obtained from different industry segments and types of fees are estimated below. Please note that these are estimates based on current projections and will be subject to minor changes based on annual updated data. However, this provides a general outline of expected fees.


·         First year only: 17% (in the first year only) from ANDA submissions pending on Oct. 1, 2012 (the backlog); 5% from DMF submissions; 20% from ANDAs and supplements (with individual PAS fee amount being half the fee for ANDAs); 46% from generic drug finished dosage form facilities; 12% from API facilities


·         Subsequent years: 6% from DMF submissions; 24% from ANDAs and supplements (with individual PAS fee amounts being half the fee amount for ANDAs); 56% from generic drug finished dosage form facilities; 14% from API facilities.