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The Drug User Fee Relief for Small Business

Specialty Pharma Association presents request for reduced GDUFA fees for Small Pharma Companies


Birmingham, AL   June 15, 2015


During the FDA's Public meeting on Reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) held today at the FDA's White Oak Campus in Silver Spring, MD, Specialty Pharma Association President and Executive Director Perry Cole presented a plan to provide financial relief in filing Abbreviated New Drug Applications (ANDA's) for small pharma companies.


The Drug User Fee Relief for Small Business would allow pharma companies with 750 employees or less to be recognized by the FDA as Small Businesses under the U.S. Small Business Administration's definition of Pharmaceutical Preparation Manufacturer (NAICS Code 325412).


Under this plan, Qualified Small Pharma companies would receive a waiver of the GDUFA fees for their first product approved as provided under the Prescription Drug User Fee Act (PDUFA). These companies would also receive a waiver of the Finished Dosage Form Facility fees (the Establishment fees) until the product is approved by the FDA.


"Requiring the small pharma companies to pay the same fees as the large companies creates an unfair disadvantage for the small companies. This severely limits competition and decreases the availability of affordable generic drugs" Cole stated.


The Specialty Pharma Association is a not for profit industry association representing pharmaceutical distributors, manufacturers and other companies active within the Specialty Pharma industry. For further information please contact Cole at pcole@specialtypharma.org         


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