GDUFA Fee Relief For Small Businesses

Pharmaceutical CommercePharmaceutical Commerce - November/December 2015

Fees paid to FDA by small generic manufacturers are financially 'unfair'

The Generic Drug User Fee Amendments of 2012

(GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires the industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. FDA held a public hearing on June 15, 2015, which began the renegotiation process for the renewal of this amendment, set to begin on October 1, 2016.

The Specialty Pharma Association (SPA), along with some other industry associations and stakeholders, is seeking relief for small businesses from some of the fees of the forthcoming GDUFA reauthorization. The GDUFA fee schedule requires all companies seeking ANDA (abbreviated new drug application) approvals to pay the same amount of fees regardless of company size. We believe the current fee schedule is financially unfair to small businesses seeking product approvals. Requiring the small companies to pay the same fees as large companies limits the small company’s ability to file for approvals and creates an unfair disadvantage for small companies to compete fairly. In an effort to provide a fair and reasonable alternative to the GDUFA fees upon reauthorization, the SPA proposes consideration of the following three suggestions:

  • That FDA recognize small companies qualifying as SBA Designated Small Businesses under the Guidelines for Pharmaceutical Preparation Manufacturers (NAICS Code 325412), which would include pharma companies with 750 or less employees seeking ANDA product approvals.
  • That FDA allow a waiver of GDUFA fees for the first product approved by a company qualifying as a small business, as currently allowed under PDUFA fees.
  • That FDA allow a waiver of the Establishment Fees (FDF) for qualifying small businesses until such time the product is approved by FDA. With an average ANDA approval time of 42 months, requiring small companies to pay this fee prior to approval and marketing creates an unfair hardship for small companies.

The GDUFA renegotiation process between FDA and the industry began in September and will require congressional approval before enactment. Some members of Congress are in favor of granting GDUFA fee relief for small businesses, which would not only benefit small businesses but the consumers as well.


Perry N. Cole is the president and executive director of the Specialty Pharma Association, (, a not-for-profit industry association representing small-to-medium companies active within the Specialty Pharma industry. Perry has been involved with the pharmaceutical industry for more than 30 years and was a cofounder and executive vice president of Abana Pharmaceuticals, Inc., which was acquired by Jones Pharma Industries in 1996.

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