Regulatory Focus™ > News Articles > User Fees Published for Drugs, Biosimilar Products

User Fees Published for Drugs, Biosimilar Products

Posted 31 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has published information regarding user fees payable to the agency between October 2012 and September 2013 for prescription drug, veterinary and biosimilar products.

The fees are part of the FDA Safety and Innovation Act (FDASIA)-a sweeping piece of legislation containing numerous user fee bills, including the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BSUFA).

The fees for all products will start being collected on 1 October 2012 and will continue until 31 September 2013, after which time they will be subject to an adjustment to account for inflation.

Prescription Drug Fees

The PDUFA component of FDASIA is expected to generate the largest amount of revenues for FDA, with fees nearing $695 million in fiscal year 2013.

New drug applications requiring clinical data will be required to pay $1,958,800 per application, while both supplements to existing applications and applications not requiring clinical data will pay $979,400.

Establishment registration will cost sponsors $526,500 and product registration will cost $98,380.

Biosimilar Fees

Biosimilar products will be subject to application fees similar to those charged for prescription drugs. A new biosimilar product application will require its sponsor to pay $1,958,800, and supplements to existing applications and applications not requiring clinical data will pay $979,400. As with pharmaceutical products, registration costs for establishments will be $526,500 per establishment and product registration will cost $98,380 as well.

Biosimilar products will be subject to some fees not paid by sponsors of prescription drugs, however. Sponsors will be required to pay an annual fee of $195,580, and will be assessed a $391,760 fee if they wish to reactivate a dormant product.

Veterinary Fees

Animal drugs-both branded and generic-will be subject to vastly reduced fees relative to their human counterparts.

New animal drug application (NADA) fees will be set at $435,200, with supplemental applications or applications not requiring data paying half that fee ($217,600). Each product will also be subject to a $8,640 registration fee, a $104,600 establishment fee and an $87,700 animal drug sponsor fee. Establishment and sponsor fees are due on an annual basis.

Generic veterinary drugs are meanwhile subject to reduced fees as well. Sponsors of abbreviated NADAs are required to pay $148,300 per application and $6,515 to register each product.

Sponsors of generic products will also be subject to a sliding scale of sponsor fees payable to FDA each year. Sponsors with more than six previously-approved applications will pay 100% of the fee ($63,000), sponsors with between two and six approved applications will pay 75% of the fee ($47,250) and sponsors with just one or no approved applications will pay 50% of the sponsor fee ($31,500).


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