GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress

On 9 July 2012, the US Congress passed the so-called "Generic Drug User Fee Act" (GDUFA). This act allows the FDA to charge Generic Drug companies who submit a marketing authorisation application for generics (Abbreviated New Drug Application; ANDA), a variation application or a Drug Master File. The FDA inspections of generic products and APIs manufacturing sites (in relation with the marketing authorisation) should also give rise to the payment of a fee.

On its "Drugs" News page, the FDA reports about the passage of the fee act and outlines its historic dimension, marking the first time the generic drug industry will directly provide such funding to the FDA. The new legislation appears to come at the right time. Over the past several years, the number of applications for generic drugs has been steadily increasing and generated a significant backlog of pending applications within the Agency. The proportion of applications from foreign i.e. non-US companies has been strongly increasing whereas the number of US-American applications has been decreasing. Facing this situation, the FDA wasn't able to process the applications on time. With GDUFA, the situation is expected to improve. The fees collected should generate around 299 millions US-Dollars and help substantially increasing the number of employees reviewers and inspectors.

With this user fee the FDA is aims for the following goals:

  • Safety. Companies participating in the U.S. generic drug system will be inspected bienially. The FDA will use a risk based approach.
  • Access. Expediting the review process for ANDAs will bring greater predictability to the review times and will make low-cost drug products earlier available on the market.
  • Transparency. Identification of all facilities involved in the manufacture of generic drugs and associated APIs will be required. This will ensure a more intense supervision of complex global supply chains.

The act passed by the Congress and signed by President Barack Obama is the result of intense discussions, meetings and negotiations with interest groups, stakeholders and the generic drug industry. It contains not only the provisions for the generic drugs user fees but also a new user fee programme for Biosimilars (BsUFA) and the revised user fee programmes for prescription drugs (PDUFA) and Medical Devices (MDUFA). As of 1 October 2012 which is the beginning of the fiscal year 2013 the FDA will start to collect the user fees.

To find further information please see the "Act to amend the Federal Food, Drug, and Cosmetic Act" which contains the user fee programmes for generic drugs and biosimilars as well as the user fee programmes for prescription drugs and medical devices.

Please also see the Press Release "Generic Drug User Fee Act (GDUFA)" issued by the FDA. On this page, you can also download PowerPoint presentations on the topic made by two FDA representatives. The speech of FDA's Head Margaret Hamburg and a testimony of CDER Director Janet Woodcock can also be downloaded.

The course "Getting Approval of Generics in the EU and USA" on 15/16 November 2012 in Vienna, Austria will explain the GDUFA and its consequences in detail.

GDUFA will also be one of the main topics discussed at the "15th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients" from 7-9 November 2012 in Budapest.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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