GDUFA Fees Jump for 2014

The FDA has calculated the 2014 fees associated with the Generic Drug User Fee Amendments. A Federal Register filing — http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf — revealed GDUFA’s inflation-based budget growth and its calculations for Facility Fees and other charges for 2014. The Federal Register did not provide an update on GDUFA’s progress in clearing ANDA backlog or facility inspections.

For Final Dosage Form (FDF) manufacturers, which includes both generic drugmakers and contract manufacturers who make generics for third parties, each U.S.-based facility will be subject to a fee of $220,152, effective October 1, 2013. Non-U.S. FDF facilities will be charged $235,152. For the previous year, those fees were $175,389 and $190,389, respectively. FDF facilities account for 56% of the total GDUFA budget, which will be $305,659,000 in 2014. The GDUFA budget in 2013 was $299 million; the increase is due to inflation related to the FDA’s Personnel Compensation and Benefits (PC&B) calculation.

API facilities, which comprise 14% of the GDUFA budget, also saw a jump in 2014 rates. U.S. API facilities owe $34,515 while foreign API facilities owe $49,515. Those fees were $26,458 and $41,458 in 2013, respectively. The $15,000 differential between domestic and foreign facilities (both API and FDF) may be adjusted in the years ahead, with a range of $15,000 and $30,000.

The jump in this year’s Facility Fees is due mainly to the absence of a one-time $50 million “backlog fee” that was paid by ANDA holders in the first year of GDUFA’s five-year term. Without the backlog fee, FDF facilities are now on the hook for $28 million more than they were in the previous year.

As we reported extensively in our March issue, CMOs that have perhaps a single generic clients are not happy that they’re subject to an identical fee paid by a mega-generic company for a facility that is exclusively devoted to generic manufacturing. One hybrid CMO subject to these fees recently told Contract Pharma that it will exit the CMO space entirely in 2014, once its contracts elapse. That company explicitly cited its GDUFA Facility Fee as the reason for this decision. Others have hinted at the same move.

If the pool of sites in the FDA’s Self-Identified Facilities list shrinks, the Facility Fee per site will increase in the years to come. In addition, such departures could lead to shortages of short-run generics that are no longer manufactured. The number of domestic FDF facilities listed on the FDA’s GDUFA page is down from 325 in 2013 to 315 in 2014. The number of foreign FDF sites was constant at 433.

ANDA and PAS fees, which comprise 24% of the GDUFA budget, rose to $63,860 and $31,930 from $51,520 and $25,760, respectively. DMF fees, which comprise the remaining 6% of the budget, increased from $21,340 to $31,460.

Fees are effective October 1, 2013 and payment information is available at www.fda.gov/gdufa.