API, Generic Drug Facilities Hit With US FDA Fee Hikes for 2014

By Zachary Brennan contact

- Last updated on GMT

API, Generic Drug Facilities Hit With US FDA Fee Hikes for 2014

Related tags: Generic drug, Food and drug administration, Us

US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.

The facility fees, announced late last week by the US FDA​, are based on the number of API (active pharmaceutical ingredients) and fixed-dose formulation facilities that self-register with the agency, as well as the amount of money the agency needs to recoup to conduct its inspections of the facilities and meet GDUFA (Generic Drug User Fee Act) timelines.

But the increases in fees come as the number of self-registered FDF (fixed-dose formulation) facilities decreased from last year, while the number of API facilities slightly increased.

John DiLoretto, executive director of the Society of Chemical Manufacturers and Affiliate’s (SOCMA) Bulk Pharmaceutical Task Force, told in-Pharmatechnologist.com the FDA’s estimates for the API fees for the first year “weren’t very concrete so we knew the numbers would be different​.” He said SOCMA expected an increase and will conduct a conference call later this week to discuss it with member companies.

GPhA (Generic Pharmaceutical Association) spokesman Steve Arnoff said the association doesn’t have an immediate comment on the fee increase.


For 2014, 748 FDF (fixed-dose formulation) facilities self-identified, including 315 US facilities that will pay $220,152 each, and 433 foreign facilities that will pay $235,152 each. The 2014 numbers saw a slight drop from the 325 US facilities that self-identified last year, and the same number of foreign facilities.

Of the 903 API facilities registering, the 128 US facilities will pay $34,515 each, while the 775 foreign facilities will pay $49,515. The latest numbers indicate an increase of six US facilities and an increase of 12 foreign API sites. Generic and API manufacturers can begin paying the fees Oct. 1.

Foreign facilities on both the API and FDF sides will pay $15,000 more than US facilities because of the cost of the foreign inspections, though that differential could go up to $30,000 in future years.

The annual API facility fee is owed by each facility producing one or more identified, or intended to be identified, APIs in at least one generic drug submission that is pending or approved, or in a Type II API drug master file referenced in a generic drug submission.

Other Fees

This FDA also set FY 2014 rates for an ANDA (abbreviated new drug application) at $63,860, prior approval supplement fee at $31,930 and the drug master file (DMF) fee at $31,460.

These fees represent a more than $10,000 increase for ANDA submissions, about $6,000 more for PAS, and more than $10,000 more for DMFs.

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