FDA’s New Program: the Generic Drug User Fee Amendments of 2012 (GDUFA)
As of October 1, 2012, all firms that manufacture human generic drugs will need to pay user fees to FDA. User fees are fees paid by industry to FDA to help FDA review manufacturers’ products in a timely manner. In exchange for these fees from industry, FDA has committed to a number of metrics:
- Application Metrics – GDUFA is a five-year program. By the fifth year of the program, FDA will review and act on 90 percent of complete electronic generic applications within 10 months after the date of submission. Certain amended applications may have different metrics, phased in between three and five years.
- Backlog Metrics – FDA will review and act on 90 percent of the generic applications already submitted to FDA and pending on October 1, 2012 within the next five years.
- Inspection Metrics – FDA will aim to achieve risk-adjusted biennial inspections and parity of inspection coverage between foreign and domestic firms in five years.
- Efficiency Enhancements – FDA has made an immediate commitment to provide timely and complete information to applicants by issuing response letters for all abbreviated new drug applications. Other efficiency enhancements include rolling review, division-level deficiency review, first cycle meetings and a number of regulatory science initiatives.
Helpful Materials for Human Generic Drug Manufacturers:
FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.
The materials available thus far include:
- Guidance for Industry, Generic Drug User Fee Amendments: Questions and Answers
- Guidance for Industry, Self-Identification of Generic Drug Facilities, Sites and Organizations
- Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations
- Federal Register Notice of Public Meeting on Generic Drug User Fee Amendments
Important Next Steps:
Generic drug entities who have not previously registered with the FDA will need time to obtain the information and the authorization necessary to comply with GDUFA’s self-identification requirement. The Facilities Self-Identification guidance highlights these preparatory steps.
On October 1, 2012, GDUFA imposes a backlog fee on any original abbreviated new drug applications that are pending and have not received tentative approval. The Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations, listed above, provides advance notice of this requirement. It also describes the process for withdrawal of applications by sponsors who no longer seek approval or do not wish to pay the fee.
To Learn More:
A public meeting is scheduled for September 2012 and will provide a forum for discussion of GDUFA, FDA’s implementation plans, and industry comments.
Please go to FDA’s GDUFA website at www.fda.gov/gdufa to find more materials and to sign up to receive emails any time new materials become available. Contact information is also listed.